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1.
BMC Musculoskelet Disord ; 25(1): 654, 2024 Aug 21.
Article in English | MEDLINE | ID: mdl-39169349

ABSTRACT

BACKGROUND: Patients surgically treated for lumbar spinal stenosis or cervical radiculopathy report improvement in approximately two out of three cases. Advancements in Machine Learning and the utility of large datasets have enabled the development of prognostic prediction models within spine surgery. This trial investigates if the use of the postoperative outcome prediction model, the Dialogue Support, can alter patient-reported outcome and satisfaction compared to current practice. METHODS: This is a prospective, multicenter clinical trial. Patients referred to a spine clinic with cervical radiculopathy or lumbar spinal stenosis will be screened for eligibility. Participants will be assessed at baseline upon recruitment and at 12 months follow-up. The Dialogue Support will be used on all participants, and they will thereafter be placed into either a surgical or a non-surgical treatment arm, depending on the decision made between patient and surgeon. The surgical treatment group will be studied separately based on diagnosis of either cervical radiculopathy or lumbar spinal stenosis. Both the surgical and the non-surgical group will be compared to a retrospective matched control group retrieved from the Swespine register, on which the Dialogue Support has not been used. The primary outcome measure is global assessment regarding leg/arm pain in the surgical treatment group. Secondary outcome measures include patient satisfaction, Oswestry Disability Index (ODI), EQ-5D, and Numeric Rating Scales (NRS) for pain. In the non-surgical treatment group primary outcome measures are EQ-5D and mortality, as part of a selection bias analysis. DISCUSSION: The findings of this study may provide evidence on whether the use of an advanced digital decision tool can alter patient-reported outcomes after surgery. TRIAL REGISTRATION: The trial was retrospectively registered at ClinicalTrials.gov on April 17th, 2023, NCT05817747. PROTOCOL VERSION: 1. TRIAL DESIGN: Clinical multicenter trial.


Subject(s)
Big Data , Lumbar Vertebrae , Patient Reported Outcome Measures , Radiculopathy , Spinal Stenosis , Humans , Prospective Studies , Spinal Stenosis/surgery , Lumbar Vertebrae/surgery , Radiculopathy/surgery , Treatment Outcome , Patient Satisfaction , Cervical Vertebrae/surgery , Multicenter Studies as Topic , Male , Female , Pain Measurement
2.
Trials ; 25(1): 553, 2024 Aug 22.
Article in English | MEDLINE | ID: mdl-39169395

ABSTRACT

BACKGROUND: Osteoarthritis (OA) contributes increasingly to disability worldwide. There is ample high-quality research on the treatment of knee and hip OA, whereas research on surgical and non-surgical treatment in hand OA is sparse. Limited evidence suggests that education and exercise may improve pain, function, stiffness, and grip strength in hand OA. The established surgical options in hand OA have disadvantages. Prostheses preserve motion but have a high complication rate, whereas fusions decrease function due to limited movement. There is an unmet need for high-quality research on treatment options for hand OA and a need for the development of effective and safe movement-sparing therapies. This study aims to compare the effects of a motion-preserving surgical treatment (denervation of the proximal interphalangeal (PIP) joint) with a patient education and exercise program on patient-reported outcomes and objective function in painful PIP OA. METHODS: In this parallel-group, two-armed, randomized, controlled superiority trial (RCT), 90 participants are assigned to surgical PIP joint denervation or education and exercise. Pain on load 1 year after intervention is the primary outcome measure. Secondary outcome measures include pain at rest, Patient-Rated Wrist and Hand Evaluation (PRWHE), HQ8 score, EQ5D-5L, objective physical function, complications, two-point discrimination, Mini Sollerman, consumption of analgesics, and the need for further surgery. Assessments are performed at baseline, 3 and 6 months, and 1 year after intervention. DISCUSSION: There are no previous RCTs comparing surgical and non-surgical treatment in PIP OA. If patient education plus exercise or PIP denervation improve function, these treatments could be implemented as first-line treatment options in PIP OA. However, if denervation does not achieve better results than non-surgical treatment, it is not justified to use in PIP OA. TRIAL REGISTRATION: Prospectively registered in ClinicalTrials.gov (NCT05980793) on 8 August 2023. URL https://classic. CLINICALTRIALS: gov/ct2/show/NCT05980793 .


Subject(s)
Denervation , Exercise Therapy , Finger Joint , Osteoarthritis , Humans , Denervation/methods , Finger Joint/surgery , Osteoarthritis/surgery , Osteoarthritis/physiopathology , Osteoarthritis/therapy , Treatment Outcome , Exercise Therapy/methods , Patient Education as Topic , Female , Pain Measurement , Middle Aged , Patient Reported Outcome Measures , Male , Time Factors , Recovery of Function , Aged , Hand Strength , Randomized Controlled Trials as Topic , Equivalence Trials as Topic
3.
N Z Med J ; 137(1601): 36-47, 2024 Aug 23.
Article in English | MEDLINE | ID: mdl-39173160

ABSTRACT

AIMS: Post mastectomy pain syndrome (PMPS) can have significant negative effects on patients' quality of life after mastectomy. The estimated prevalence of PMPS varies widely and there is little data from a New Zealand population. This limits clinicians' ability to meaningfully describe and discuss pain-related complications of mastectomy peri-operatively. METHOD: We designed a single-centre, retrospective study to describe acute post-operative analgesic requirements after mastectomy, to describe the prevalence of PMPS at least 1 year after surgery, and to identify associated risk factors for this complication. RESULTS: One hundred and thirty mastectomy patients met inclusion criteria and 59 were willing and able to participate in 12-month follow-up. Acute post-operative pain was generally well managed with modest doses of oral analgesics. Sixty-six percent (n=39) of women reported some form of persistent pain symptoms post-mastectomy; this was associated with younger age, axillary surgery and chemotherapy. Only 5% of patients (n=3) met consensus criteria for PMPS, which limited identification of risk factors for this more severe complication. CONCLUSION: Despite PMPS occurring infrequently, post-operative pain of a less severe nature after mastectomy occurs commonly. Clinicians should remain vigilant to possible risk factors for this post-operative complication and counsel patients appropriately.


Subject(s)
Breast Neoplasms , Mastectomy , Pain, Postoperative , Tertiary Care Centers , Humans , Female , Pain, Postoperative/drug therapy , Pain, Postoperative/epidemiology , Pain, Postoperative/etiology , Mastectomy/adverse effects , Middle Aged , Retrospective Studies , Adult , Aged , Breast Neoplasms/surgery , Risk Factors , Analgesics/therapeutic use , New Zealand/epidemiology , Acute Pain/etiology , Acute Pain/drug therapy , Acute Pain/epidemiology , Prevalence , Chronic Pain/epidemiology , Chronic Pain/etiology , Chronic Pain/drug therapy , Pain Measurement
4.
Clin Oral Investig ; 28(9): 483, 2024 Aug 13.
Article in English | MEDLINE | ID: mdl-39136788

ABSTRACT

OBJECTIVES: The aim of this study was to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets. MATERIALS AND METHODS: This double-blind, randomized clinical study was completed with 34 patients, who had an indication for extraction of their bilaterally impacted teeth. The right and left teeth of the patients were randomly divided into L-PRF and PBM groups. L-PRF group was treated with the blood product centrifuged for 12 min at 2700 rpm, and the PBM group was treated with a diode laser at different points for 60 s with a wavelength of 940 nm in repeated sessions. Postoperative pain was evaluated using Visual Analogue Scale (VAS), soft tissue healing with Landry Index (LI), tissue healing in the distal region of mandibular second molar by probing depth measurement, and bone healing via panoramic x-ray using the Image J program. RESULTS: No statistically significant difference was found for any variable compared between the groups. CONCLUSION: L-PRF and PBM applications provide similar support in the healing of extraction sockets. Nevertheless, the advantages and disadvantages of both methods determine their usage areas. CLINICAL RELEVANCE: While L-PRF is advantageous in the early healing of extraction sockets, PBM may be preferred in terms of bone trabeculation in the long term.


Subject(s)
Leukocytes , Low-Level Light Therapy , Molar, Third , Pain, Postoperative , Platelet-Rich Fibrin , Tooth Extraction , Tooth Socket , Wound Healing , Humans , Low-Level Light Therapy/methods , Female , Double-Blind Method , Male , Wound Healing/radiation effects , Adult , Molar, Third/surgery , Leukocytes/radiation effects , Tooth, Impacted/surgery , Tooth, Impacted/therapy , Radiography, Panoramic , Pain Measurement , Lasers, Semiconductor/therapeutic use , Treatment Outcome
5.
Trials ; 25(1): 537, 2024 Aug 14.
Article in English | MEDLINE | ID: mdl-39138506

ABSTRACT

BACKGROUND: Ultrasound-guided supraclavicular block (UGSCB) is an emerging technique gaining interest amongst emergency physicians that provides regional anaesthesia to the upper limb to tolerate painful procedures. It offers an alternative to the more traditional technique of a Bier block (BB). However, the effectiveness or safety of UGSCB when performed in the emergency department (ED) is unclear. METHODS: SUPERB (SUPraclavicular block for Emergency Reduction versus Bier block) is a prospective open-label non-inferiority randomised controlled trial comparing the effectiveness of UGSCB versus BB for closed reduction of upper limb fractures and/or dislocations. Adult patients presenting with upper limb fracture and/or dislocation requiring closed reduction in ED were randomised to either UGSCB or BB. Once regional anaesthesia is obtained, closed reduction of the injured part was performed and immobilised. The primary outcome is maximal pain experienced during closed reduction measured via a visual analogue scale (VAS). Secondary outcomes include post-reduction pain, patient satisfaction, total opioid requirement in ED, ED length of stay, adverse events and regional anaesthesia failure. RESULTS: Primary outcome analysis will be performed using both the intention-to-treat and per-protocol populations. The between-group difference in maximum pain intensity will be assessed using linear regression modelling with trial group allocation (UGSCB vs BB) included as a main affect. A pre-specified non-inferiority margin of 20 mm on the VAS scale will be used to establish non-inferiority of UGSCB compared to BB. CONCLUSION: SUPERB is the first randomised controlled trial to investigate the effectiveness and safety of UGSCB in the ED. The trial has the potential to demonstrate that UGSCB is an alternative safe and effective option for the management of upper extremity emergencies in the ED.


Subject(s)
Emergency Service, Hospital , Ultrasonography, Interventional , Upper Extremity , Humans , Ultrasonography, Interventional/methods , Prospective Studies , Upper Extremity/innervation , Pain Measurement , Nerve Block/methods , Nerve Block/adverse effects , Treatment Outcome , Fractures, Bone , Brachial Plexus Block/methods , Brachial Plexus Block/adverse effects , Equivalence Trials as Topic , Closed Fracture Reduction/methods , Closed Fracture Reduction/adverse effects , Joint Dislocations/therapy , Data Interpretation, Statistical , Patient Satisfaction
6.
J Med Life ; 17(5): 478-485, 2024 May.
Article in English | MEDLINE | ID: mdl-39144688

ABSTRACT

Chronic low back pain (LBP) is very common, resulting in functional deficits and significant socio-economic burden. Non-pharmacological treatments, such as physical-psychological therapy, are frequently utilized. Vojta therapy (VT) is a type of physical therapy that effectively enhances the automatic control of body posture. This study aimed to evaluate the effects of combining VT with the usual standard of care (USC) therapy on psychometric and functional parameters in patients with chronic LBP. A total of 148 patients diagnosed with chronic LBP were recruited and randomized into two groups: LBP-VT (n = 82) and LBP-USC (n = 66). Patients were assessed for demographic characteristics, comorbid conditions, clinical findings, health status, pain symptom scales, psychometric, and functional parameters. The LBP-VT group received VT in addition to USC and electrotherapy, while the LBP-USC group received only USC. Initial Hamilton Depression Scale assessments indicated moderate depression, which improved to mild depression post-treatment. The effect of the treatment on self-esteem was significant for the LBP-VT group and moderate for the LBP-USC group. Functional parameters improved in both groups, with the LBP-VT group having significantly better results. Combining VT with standard care, electrotherapy, and massage significantly improved posture, reduced depression associated with functional deficits, and enhanced self-esteem in patients with chronic LBP.


Subject(s)
Low Back Pain , Physical Therapy Modalities , Psychometrics , Humans , Low Back Pain/therapy , Low Back Pain/psychology , Male , Female , Middle Aged , Adult , Chronic Pain/therapy , Chronic Pain/psychology , Standard of Care , Pain Measurement , Treatment Outcome
7.
Pain Res Manag ; 2024: 6866549, 2024.
Article in English | MEDLINE | ID: mdl-39145150

ABSTRACT

Background: The effect of transcutaneous electrical nerve stimulation (TENS) on pain and impression of change was assessed during a 2.5-hour intervention on the first postoperative days following hip surgery in a randomized, single-blinded, placebo-controlled trial involving 30 patients. Methods: Mixed-frequency TENS (2 Hz/80 Hz) was administered using specially designed pants integrating modular textile electrodes to facilitate stimulation both at rest and during activity. The treatment outcome was assessed by self-reported pain Numerical Rating Scale (NRS) and Patient Global Impression of Change (PGIC) scores at four time points. The ability to perform a 3-meter walk test and the use of analgesics were also evaluated. Group comparison and repeated-measure analysis were carried out using nonparametric statistics. Results: The active TENS group exhibited significantly higher PGIC scores after 30 minutes, which persisted throughout the intervention (all p ≤ 0.001). A reduction in NRS appeared after one hour of active TENS, persisting throughout the intervention (all p ≤ 0.05). The median group differences in pain ratings were greater than the minimum clinically important difference, and the analysis of pain trajectories confirmed clinical significance at the individual level. Moreover, patients in the active TENS group were more likely able to perform a 3-meter walk test by the end of the intervention (p = 0.04). Analysis of the opioid-sparing effect of TENS was inconclusive (p = 0.066). No postoperative surgical complications or TENS-related side effects were observed during the study. Conclusion: Mixed-frequency TENS integrated in pants could potentially be an interesting addition to the arsenal of treatments for multimodal analgesia following hip surgery. This trial is registered with NCT05678101.


Subject(s)
Pain Measurement , Pain, Postoperative , Transcutaneous Electric Nerve Stimulation , Humans , Transcutaneous Electric Nerve Stimulation/methods , Male , Female , Pain, Postoperative/therapy , Pain, Postoperative/etiology , Middle Aged , Aged , Single-Blind Method , Treatment Outcome , Adult , Pain Management/methods , Hip/surgery
8.
Aesthet Surg J ; 44(Supplement_1): S22-S30, 2024 Aug 16.
Article in English | MEDLINE | ID: mdl-39147384

ABSTRACT

The procedure with the highest rate of opioid prescription in plastic surgery is abdominoplasty. Additionally, plastic surgery patients are at a particularly elevated risk of becoming opioid-dependent. The main objective of this study was to perform a systematic review and create an algorithm for a multimodal pain regimen specific to patients undergoing abdominoplasty. A systematic search of the research literature was performed to summarize the prevailing understanding of multimodal pain control in the management of abdominoplasty. The initial search yielded 448 articles. Sixty-eight manuscripts were identified for full-text review. The effectiveness of current strategies was evaluated by way of pain scores, opioid usage, and length of stay, as well as other measures of physical function such as time to early mobilization. In 32 studies involving 2451 patients, the efficacy of different pain regimens during abdominoplasty was evaluated. Among nontraditional, opioid-sparing analgesia, efficacy of treatment interventions for improved pain and decreased opioid usage was found inall studies. Among local infusion studies, efficacy of treatment interventions for improved pain and decreased opioid usage was found in 78% of studies. Last, among regional block studies, efficacy of treatment interventions for improved pain was found in 87%, with 73% efficacy for decreased opioid usage. Multimodal pain regimens in abdominoplasty have the potential to play an important role in opioid-sparing practices in medicine by incorporating nonopioid pain adjuvants such as nonsteroidal anti-inflammatory drugs and transversus abdominis plane blocks in the preoperative, perioperative, and postoperative periods.


Subject(s)
Abdominoplasty , Algorithms , Analgesics, Opioid , Pain Management , Pain, Postoperative , Humans , Abdominoplasty/adverse effects , Pain, Postoperative/etiology , Pain, Postoperative/prevention & control , Pain, Postoperative/diagnosis , Pain, Postoperative/drug therapy , Pain Management/methods , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/therapeutic use , Pain Measurement , Treatment Outcome , Nerve Block/methods , Opioid-Related Disorders/prevention & control , Opioid-Related Disorders/etiology
9.
BMC Oral Health ; 24(1): 976, 2024 Aug 22.
Article in English | MEDLINE | ID: mdl-39174937

ABSTRACT

BACKGROUND: Dental simulation games are virtual educational games that help children get familiar with different dental procedures. This study aimed to evaluate the pretreatment exposure to the "Baby Panda Dental Care" game in reducing pain and anxiety in comparison with the tell-show-do (TSD) technique during primary molars pulpotomy for patients aged 6-10 years. MATERIALS AND METHODS: It was a triple-blinded, two-arm, parallel-group, randomized, active-controlled trial. It was done on 60 patients, who were randomly divided into two groups: the control group, TSD technique (n = 30), and the experimental group, "Baby Panda Dental" Care (n = 30). For the TSD technique, children were provided with a verbal explanation followed by a demonstration of the dental treatment in a non-threatening way. The "do" phase is then initiated during performing treatment. For the "Baby Panda dental care" game, children were asked to play for 5 min before treatment, selecting root canal therapy procedures. Pulse rate and RMS pictorial scale were recorded at four time points: (1) at the baseline (t0). (2) After conditioning the child (t1). (3) During treatment (t2). (4) After finishing the treatment (t3). Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale was recorded during treatment (t2). RESULTS: The pulse rate is higher in the control group at t1 (p = 0.012) and t2 (p = 0.015). There was a statistically significant difference in the mean RMS pictorial scale score at t1 (p < 0.001), t2 (p = 0.006), and t3 (p < 0.001), a statistically significant difference was noticed in FLACC behavioral pain assessment between the two groups (p = 0.033). CONCLUSIONS: The mobile dental game showed better results than the TSD technique, but neither technique did not reduce anxiety and pain effectively during dental treatment. TRIAL REGISTRATION: The trial was registered at the ISRCTN registry (ISRCTN30470866) on 19/04/2024.


Subject(s)
Dental Anxiety , Molar , Pulpotomy , Tooth, Deciduous , Humans , Pulpotomy/methods , Child , Male , Female , Dental Anxiety/prevention & control , Dental Anxiety/psychology , Video Games , Pain Measurement
10.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi ; 38(8): 917-922, 2024 Aug 15.
Article in Chinese | MEDLINE | ID: mdl-39175311

ABSTRACT

Objective: To compare the effectiveness of robot-assisted and traditional freehand screw placement in the treatment of atlantoaxial dislocation. Methods: The clinical data of 55 patients with atlantoaxial dislocation who met the selection criteria between January 2021 and January 2024 were retrospectively analyzed. According to different screw placement methods, they were divided into the traditional group (using the traditional freedhand screw placement, 31 cases) and the robot group (using the Mazor X robot-assisted screw placement, 24 cases). There was no significant difference in gender, age, body mass index, etiology, and preoperative visual analogue scale (VAS) score, cervical spine Japanese Orthopaedic Association (JOA) score between the two groups ( P>0.05). The operation time, intraoperative blood loss, operation cost, and intraoperative complications were recorded and compared between the two groups. The VAS score and cervical spine JOA score were used to evaluate the improvement of pain and cervical spinal cord function before operation and at 1 month after operation. CT examination was performed at 3 days after operation, and the accuracy of screw placement was evaluated according to Neo grading criteria. Results: All the 55 patients successfully completed the operation. The operation time, intraoperative blood loss, and operation cost in the robot group were significantly higher than those in the traditional group ( P<0.05). A total of 220 C 1 and C 2 pedicle screws were inserted in the two groups, and 94 were inserted in the robot group, with an accuracy rate of 95.7%, among them, 2 were inserted by traditional freehand screw placement due to bleeding caused by intraoperative slip. And 126 pedicle screws were inserted in the traditional group, with an accuracy rate of 87.3%, which was significantly lower than that in the robot group ( P<0.05). There were 1 case of venous plexus injury in the robot group and 3 cases in the traditional group, which improved after pressure hemostasis treatment. No other intraoperative complication such as vertebral artery injury or spinal cord injury occurred in both groups. All patients were followed up 4-16 months with an average of 6.6 months, and there was no significant difference in the follow-up time between the two groups ( P>0.05). Postoperative neck pain significantly relieved in both groups, and neurological symptoms relieved to varying degrees. The VAS score and cervicle spine JOA score of both groups significantly improved at 1 month after operation when compared with preoperative scores ( P<0.05), and there was no significant difference in the score change between the two groups ( P>0.05). Conclusion: In the treatment of atlantoaxial dislocation, the accuracy of robot-assisted screw placement is superior to the traditional freedhand screw placement.


Subject(s)
Atlanto-Axial Joint , Joint Dislocations , Robotic Surgical Procedures , Humans , Robotic Surgical Procedures/methods , Treatment Outcome , Joint Dislocations/surgery , Male , Atlanto-Axial Joint/surgery , Female , Operative Time , Cervical Vertebrae/surgery , Bone Nails , Retrospective Studies , Spinal Fusion/methods , Pain Measurement , Adult
11.
Lasers Med Sci ; 39(1): 211, 2024 Aug 08.
Article in English | MEDLINE | ID: mdl-39115705

ABSTRACT

PURPOSE: To evaluate the effect of post-surgical photobiomodulation therapy in dogs. METHODS: Twenty dogs were selected for elective gastropexy and randomly divided into a control (CG, n = 10) and a PBMT group (PBMTG, n = 10). Pre­medication consisted of medetomidine and butorphanol. Meloxicam was administered before the procedure. Induction was performed with propofol and maintained with sevoflurane. Local blocks with lidocaine were used. Incisional gastropexy was performed in all animals. PBMTG received PBMT immediately after surgery. The need for postoperative rescue analgesia, if the animal had eaten by the evaluation momen, and pain scores were collected using the Glasgow Composite Measure Pain Scale - Short Form (CMPS­SF) at 1, 2, 4, 6, 8, 12, 16, 20, and 24 h post­endotracheal extubation. CMPS­SF scores were compared with the Mann-Whitney Test and proportions of animals that required rescue analgesia and had eaten with a χ2 test. P was set at < 0.05. RESULTS: No rescue analgesia was needed for any animal. Still, significant differences were observed in CMPS-SF scores between CG and PBMTG between 1 and 4 h post-extubation. PBMTG had a significantly higher proportion of animals eating up to the 8 h post-extubation evaluation moment. CONCLUSION: Adding post-surgical photobiomodulation to a standard anesthesia and analgesia protocol reduced CMPS-SF scores and increased the proportion of animals that resumed eating compared to the standard protocol alone.


Subject(s)
Gastric Dilatation , Gastropexy , Low-Level Light Therapy , Stomach Volvulus , Low-Level Light Therapy/veterinary , Gastropexy/veterinary , Animals , Dogs , Gastric Dilatation/surgery , Stomach Volvulus/surgery , Medetomidine/administration & dosage , Meloxicam/administration & dosage , Butorphanol/administration & dosage , Propofol/administration & dosage , Sevoflurane/administration & dosage , Treatment Outcome , Anesthesia , Analgesia , Pain Measurement/veterinary , Analgesics/administration & dosage
12.
Clin Transl Sci ; 17(8): e70005, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39177194

ABSTRACT

Chronic pain is a prevalent condition with enormous economic burden. Opioids such as tramadol, codeine, and hydrocodone are commonly used to treat chronic pain; these drugs are activated to more potent opioid receptor agonists by the hepatic CYP2D6 enzyme. Results from clinical studies and mechanistic understandings suggest that CYP2D6-guided therapy will improve pain control and reduce adverse drug events. However, CYP2D6 is rarely used in clinical practice due in part to the demand for additional clinical trial evidence. Thus, we designed the ADOPT-PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) chronic pain study, a multicenter, pragmatic, randomized controlled clinical trial, to assess the effect of CYP2D6 testing on pain management. The study enrolled 1048 participants who are taking or being considered for treatment with CYP2D6-impacted opioids for their chronic pain. Participants were randomized to receive immediate or delayed (by 6 months) genotyping of CYP2D6 with clinical decision support (CDS). CDS encouraged the providers to follow the CYP2D6-guided trial recommendations. The primary study outcome is the 3-month absolute change in the composite pain intensity score assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Follow-up will be completed in July 2024. Herein, we describe the design of this trial along with challenges encountered during enrollment.


Subject(s)
Analgesics, Opioid , Chronic Pain , Cytochrome P-450 CYP2D6 , Humans , Chronic Pain/drug therapy , Analgesics, Opioid/therapeutic use , Analgesics, Opioid/adverse effects , Cytochrome P-450 CYP2D6/genetics , Cytochrome P-450 CYP2D6/metabolism , Male , Female , Pain Management/methods , Middle Aged , Pragmatic Clinical Trials as Topic , Pain Measurement , Pharmacogenomic Testing , Adult , Precision Medicine/methods
13.
Updates Surg ; 76(4): 1161-1167, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39117876

ABSTRACT

Excisional haemorrhoidectomy is the gold standard for operating haemorrhoids, but it is accompanied by a significant problem: postoperative pain. Several strategies have been adopted to minimize this condition. Oral metronidazole has been proven to reduce postoperative pain but with some complications. This systematic review was conducted to investigate the effects and general efficacy of topical metronidazole administration and to evaluate its potential superiority over the oral formula. A systematic review of the literature was carried out. Randomized controlled trials published until September 2023 on PubMed, Central, and Web of Science were considered. The primary outcome considered was postoperative pain, which was evaluated using visual analogue scores. The secondary outcomes were analgesic use, return to work, and complications. Six randomized controlled trials were included, with a total of 536 patients. Topical metronidazole was compared with placebo in two studies, with oral formula in three studies, and with placebo and oral administration in one study. Topical metronidazole was found to be effective for treating postoperative pain when compared to a placebo but had no significant advantage over the oral formula. No complications were reported in the studies. Topical and oral metronidazole are effective solutions for postoperative pain after excisional haemorrhoidectomy. No superiority was demonstrated based on the route of administration, and complications were marginal for both formulas. Further studies are required to determine the best metronidazole solution.


Subject(s)
Administration, Topical , Hemorrhoidectomy , Metronidazole , Pain, Postoperative , Randomized Controlled Trials as Topic , Humans , Metronidazole/administration & dosage , Hemorrhoidectomy/methods , Hemorrhoidectomy/adverse effects , Pain, Postoperative/prevention & control , Pain, Postoperative/drug therapy , Administration, Oral , Hemorrhoids/surgery , Treatment Outcome , Pain Measurement
14.
Vet Anaesth Analg ; 51(5): 531-538, 2024.
Article in English | MEDLINE | ID: mdl-39142979

ABSTRACT

OBJECTIVE: To clinically evaluate previously developed pain scales [Donkey Chronic Pain Composite Pain Scale (DCP-CPS), Donkey Chronic Pain Facial Assessment of Pain (DCP-FAP) and combined Donkey Chronic Pain Scale (DCPS)], including behavioural and facial expression-based variables, for the assessment of chronic pain in donkeys. STUDY DESIGN: Prospective, blinded clinical study. ANIMAL: A group of 77 donkeys (34 patients and 43 healthy control animals). METHODS: Animals were assessed by two observers that were blinded to the condition of the animals. RESULTS: Both DCP-CPS and DCP-FAP, and resulting combined DCPS scores, showed good interobserver reliability [intraclass correlation coefficient (ICC) = 0.91, 95% confidence interval (CI) = 0.86-0.95, p < 0.001; ICC = 0.71, CI = 0.50-0.83, p < 0.001 and ICC = 0.84, CI = 0.72-0.91, p < 0.001, respectively]. All scores (DCP-CPS, DCP-FAP and the resulting combined DCPS) were significantly higher for patients than for controls at all time points (p < 0.001 for all three scales). Sensitivity and specificity for identification of pain (cut-off value >3) was 73.0% and 65.1% for DCP-CPS, and 60.9% and 83.3% for DCP-FAP, respectively. For the combined DCPS, sensitivity was 87.0% and specificity 90.9% (cut-off value >6). CONCLUSIONS AND CLINICAL RELEVANCE: Based on behavioural and facial expression-based variables, DCPS proved a promising and reproducible tool to assess different types of chronic pain in donkeys. The combination of behavioural and facial expression-based variables showed the best discriminatory characteristics in the current study. Further studies are needed for refinement of these tools.


Subject(s)
Chronic Pain , Equidae , Pain Measurement , Animals , Chronic Pain/veterinary , Pain Measurement/veterinary , Pain Measurement/methods , Female , Male , Prospective Studies , Facial Expression , Behavior, Animal , Reproducibility of Results , Sensitivity and Specificity
15.
Anaesthesiol Intensive Ther ; 56(2): 98-107, 2024.
Article in English | MEDLINE | ID: mdl-39166501

ABSTRACT

INTRODUCTION: This study, conducted between December 2015 and March 2018 at a single university hospital, explored the feasibility and safety of opioid-free anesthesia combined with preoperative thoracic paravertebral block (ThPVB) for patients undergoing elective video-assisted thoracoscopic surgery (VATS). The aim was to assess the impact of this approach on postoperative pain levels and opioid consumption. MATERIAL AND METHODS: Sixty-four patients scheduled for elective VATS were randomly assigned to either the intervention group, receiving opioid-free anesthesia with ThPVB, or the control group, managed with standard general anesthesia. Postoperatively, both groups received oxycodone patient-controlled analgesia along with non-opioid analgesics. Pain intensity was measured using the Numeric Pain Rating Scale (NRS) and Prince Henry Hospital Pain Score (PHHPS). The total dose of postoperative oxycodone and the occurrence of opioid-related adverse events were recorded during the 24-hour follow-up period. RESULTS: Patients in the intervention group showed significantly lower pain levels at 20 and 24 hours post-procedure ( P = 0.015, P = 0.021, respectively) compared to the control group. Notably, oxycodone consumption at 24 hours was significantly higher in the control group ( p < 0.0001). No serious adverse events were observed during the study period. CONCLUSIONS: This study demonstrates the feasibility and safety of opioid-free anesthesia combined with ThPVB for elective VATS. The approach significantly reduces postoperative pain and the need for opioids, supporting its potential as an effective and balanced perioperative anesthetic strategy.


Subject(s)
Analgesia, Patient-Controlled , Analgesics, Opioid , Feasibility Studies , Nerve Block , Oxycodone , Pain, Postoperative , Thoracic Surgery, Video-Assisted , Humans , Thoracic Surgery, Video-Assisted/methods , Male , Female , Oxycodone/administration & dosage , Oxycodone/therapeutic use , Middle Aged , Pain, Postoperative/drug therapy , Pain, Postoperative/prevention & control , Analgesia, Patient-Controlled/methods , Nerve Block/methods , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/therapeutic use , Adult , Aged , Analgesics, Non-Narcotic/administration & dosage , Analgesics, Non-Narcotic/therapeutic use , Pain Measurement , Perioperative Care/methods
16.
Anaesthesiol Intensive Ther ; 56(2): 121-128, 2024.
Article in English | MEDLINE | ID: mdl-39166503

ABSTRACT

INTRODUCTION: The significant effect of deep neuromuscular block (NMB) in laparoscopic surgery is still controversial, especially in lower-pressure pneumoperitoneum. This study investigates the effect of deep neuromuscular block on intraabdominal pressure (IAP), surgical space quality, post-operative abdominal pain, and shoulder tip pain in laparoscopic gynaecological surgery. MATERIAL AND METHODS: This is a randomised, double-blinded control trial which randomised samples to moderate NMB (train-of-four count [TOF] of 1 or 2) or deep NMB (post-tetanic count [PTC] of 1 or 2). Surgery began with IAP 8 mmHg but was allowed to increase the pressure if the surgical condition was unfavourable. The surgical condition was rated on a 4-point scale. Post-operative abdominal pain and shoulder tip pain was assessed using a numerical rating scale for pain, with 0 defined as no pain and 10 severe pain at recovery area (time 0), 30 minutes, and 24 hours post-operation. RESULTS: Seventy patients completed the study. The rate of increasing IAP between the 2 groups ( P = 0.172) is not significant, but deep NMB requires less pressure - mean highest IAP of 10.31 (± 1.39) mmHg, moderate NMB 11.54 (± 1.69) mmHg. The mean surgical space condition score was significantly better in the deep NMB group at 2.4 (± 0.7) compared to moderate NMB at 3.2 (± 0.66), P < 0.005. There was a significantly lower post-operative abdominal pain score in deep NMB but no significant difference in shoulder tip pain score between the 2 groups. CONCLUSIONS: Deep NMB enables the usage of lower IAP in laparoscopic surgery without interfering with surgical space condition, and it reduces the post-operative abdominal pain score in 24 hours compared to moderate NMB.


Subject(s)
Gynecologic Surgical Procedures , Laparoscopy , Neuromuscular Blockade , Pain, Postoperative , Pneumoperitoneum, Artificial , Pressure , Humans , Laparoscopy/methods , Female , Neuromuscular Blockade/methods , Double-Blind Method , Gynecologic Surgical Procedures/methods , Pneumoperitoneum, Artificial/methods , Adult , Middle Aged , Abdominal Pain/etiology , Shoulder Pain/etiology , Pain Measurement/methods
17.
Anaesthesiol Intensive Ther ; 56(2): 151-159, 2024.
Article in English | MEDLINE | ID: mdl-39166507

ABSTRACT

INTRODUCTION: Patients suffering from severe chronic pain often have problems finding an appropriate combination of painkillers. We retrospectively evaluated the effectiveness and safety of pulsed radiofrequency ablation (pRFA) of the genicular nerves in 96 patients with knee osteoarthritis (KO). We hypothesized that age, sex, and body mass index (BMI) may influence the quality of the pRFA treatment. MATERIAL AND METHODS: A diagnostic blockade with total volume of 9 ml of 1% lidocaine (WZF, Poland) combined with 4 mg of dexamethasone with subsequent pRFA with a radio frequency of 300-500 kHz under ultrasound guidance was used during the procedure. The study participants were assessed during regular monthly visits until 12 months. RESULTS: The nerves' ultrasound identification was successful in 90.62% of the cases. According to the numeric rating scale (NRS), pain was reduced by 50% or more in 64.06% of the cases. The average pain relief period lasted just over 7 and a half months. There were no pRFA-related complications or side effects of the drugs used. CONCLUSIONS: pRFA seems to be safe and effective for the treatment of chronic pain in KO. The outcome of the treatment may be related to the patient's age (block duration increased with patient age) and sex (in women, the therapeutic effect was more effectively prolonged) in our study group. There was also higher effectiveness of pRFA in high-BMI patients, which was close to statistical significance ( P = 0.053).


Subject(s)
Chronic Pain , Osteoarthritis, Knee , Humans , Female , Male , Retrospective Studies , Osteoarthritis, Knee/complications , Osteoarthritis, Knee/therapy , Aged , Middle Aged , Chronic Pain/therapy , Chronic Pain/etiology , Treatment Outcome , Pulsed Radiofrequency Treatment/methods , Pain Measurement , Aged, 80 and over , Age Factors , Lidocaine/administration & dosage , Lidocaine/therapeutic use , Sex Factors , Ultrasonography, Interventional/methods , Body Mass Index
18.
Rev Assoc Med Bras (1992) ; 70(7): e20231599, 2024.
Article in English | MEDLINE | ID: mdl-39166658

ABSTRACT

OBJECTIVE: The objective of this study was to determine the effects of listening to nature sounds alone and virtual reality plus listening to nature sounds on pain and anxiety in hysterosalpingography. METHODS: This three-arm parallel randomized controlled trial included 135 (45 in each group) women who underwent hysterosalpingography in Turkey. The virtual reality+nature sounds group viewed a nature video with virtual reality glasses and listened to nature sounds during hysterosalpingography, whereas the nature sounds group only listened to nature sounds. The control group received only routine care. RESULTS: During hysterosalpingography, women in virtual reality+nature sounds group experienced less pain than those in control group (p=0.009). After hysterosalpingography, pain levels were lower in both virtual reality+nature sounds group and nature sounds group than in control group (p=0.000 and p=0.000, respectively), anxiety levels were lower in virtual reality+nature sounds group than in nature sounds group and control group (p=0.018 and p=0.000, respectively), and anxiety levels were lower in nature sounds group than in control group (p=0.013). CONCLUSION: Virtual reality with nature content plus listening to nature sounds and only listening to nature sounds are effective in reducing pain and anxiety related to hysterosalpingography procedures in women. Compared with only listening to nature sounds, virtual reality plus listening to nature sounds further reduced hysterosalpingography-related pain and anxiety.


Subject(s)
Anxiety , Hysterosalpingography , Virtual Reality , Humans , Female , Hysterosalpingography/methods , Hysterosalpingography/adverse effects , Adult , Anxiety/prevention & control , Anxiety/psychology , Sound , Pain Measurement , Pain/psychology , Pain/prevention & control , Young Adult , Turkey
19.
Rev Assoc Med Bras (1992) ; 70(7): e20231651, 2024.
Article in English | MEDLINE | ID: mdl-39166659

ABSTRACT

OBJECTIVE: The aim of the study was to evaluate the impact of laparoscopic surgical treatment of endometriosis on the levels of health-related depression in patients using a validated questionnaire. METHODS: A prospective study was carried out between September 2020 and May 2022 in a private hospital (São Luís, Maranhão, Brazil), which analysed depression using the Beck Depression Inventory-II, on 103 patients undergoing surgical treatment for endometriosis, evaluated preoperatively and 3 and 6 months after the procedure. Patients with unsuccessful clinical treatment for endometriosis and pain level ≥7 on Visual Analog Scale and who agreed to participate in the study were included. Demographic data were acquired by consulting medical records. RESULTS: The average age of the participants was 36±6.3 years; the majority of patients were brown (68.6%), married (66.6%), overweight (55.8%), had had hormonal treatments with progestogens (50.9%), low fertility (50.9%), severe endometriosis (39.3%), endometriosis surgery+myomectomy (29.4%) and one (1%) patient withdrew from the study. There was a statistically significant reduction in mean Beck Depression Inventory between the preoperative period and 6 months after surgery (p<0.0001). CONCLUSION: Surgical treatment of endometriosis appears to have a positive impact on the symptoms of depression in the patients evaluated.


Subject(s)
Depression , Endometriosis , Laparoscopy , Video-Assisted Surgery , Humans , Female , Endometriosis/surgery , Endometriosis/psychology , Adult , Prospective Studies , Laparoscopy/methods , Video-Assisted Surgery/methods , Treatment Outcome , Surveys and Questionnaires , Psychiatric Status Rating Scales , Brazil , Middle Aged , Pain Measurement
20.
BMJ Open ; 14(8): e085702, 2024 Aug 17.
Article in English | MEDLINE | ID: mdl-39153773

ABSTRACT

OBJECTIVES: To explore the relationship between age and postoperative 24-hour moderate-to-severe pain after radical resection of lung cancer and the specific effect of moderate-to-severe pain in the post-anaesthesia care unit (PACU) on this relationship. DESIGN: Retrospective cohort study. SETTING: Single medical centre. PARTICIPANTS: Patients ≥18 years having radical resection of lung cancer between 2018 and 2020. MEASUREMENTS: Postoperative 24-hour moderate-to-severe pain. RESULTS: A total of 3764 patients were included in the analysis. The incidence of postoperative 24-hour moderate-to-severe pain was 28.3%. Age had a significant effect on the prediction model of postoperative 24-hour moderate-to-severe pain. Among the whole population and those without moderate-to-severe pain in the PACU, those who were younger than 58.5 years were prone to experience moderate-to-severe pain 24 hours after surgery, and in patients with moderate-to-severe pain in the PACU, the age threshold was 62.5 years. CONCLUSION: For patients who underwent elective radical resection for lung cancer, age was related to postoperative 24-hour moderate-to-severe pain, and moderate-to-severe pain in the PACU had a specific effect on this relationship. Patients among the whole population and those patients without moderate-to-severe pain in the PACU were more likely to experience postoperative 24-hour moderate-to-severe pain when they were younger than 58.5 years old, and in patients with moderate-to-severe pain in the PACU, the age threshold was 62.5 years old.


Subject(s)
Lung Neoplasms , Pain, Postoperative , Humans , Lung Neoplasms/surgery , Male , Female , Pain, Postoperative/etiology , Retrospective Studies , Middle Aged , Aged , Age Factors , Pain Measurement , Adult , Anesthesia Recovery Period
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