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2.
Front Cardiovasc Med ; 11: 1343549, 2024.
Article in English | MEDLINE | ID: mdl-38978789

ABSTRACT

Background: Cannabis is one of the most widely used psychoactive substances. Its components act through several pathways, producing a myriad of side effects, of which cardiovascular events are the most life-threatening. However, only a limited number of studies address cannabis's perioperative impact on patients during noncardiac surgery. Methods: Studies were identified by searching the PubMed, Medline, EMBASE, and Google Scholar databases using relevant keyword combinations pertinent to the topic. Results: Current evidence shows that cannabis use may cause several cardiovascular events, including abnormalities in cardiac rhythm, myocardial infarction, heart failure, and cerebrovascular events. Additionally, cannabis interacts with anticoagulants and antiplatelet agents, decreasing their efficacy. Finally, the interplay of cannabis with inhalational and intravenous anesthetic agents may lead to adverse perioperative cardiovascular outcomes. Conclusions: The use of cannabis can trigger cardiovascular events that may depend on factors such as the duration of consumption, the route of administration of the drug, and the dose consumed, which places these patients at risk of drug-drug interactions with anesthetic agents. However, large prospective randomized clinical trials are needed to further elucidate gaps in the body of knowledge regarding which patient population has a greater risk of perioperative complications after cannabis consumption.

3.
J Pain Res ; 17: 1601-1638, 2024.
Article in English | MEDLINE | ID: mdl-38716038

ABSTRACT

Clinical management of sacroiliac disease has proven challenging from both diagnostic and therapeutic perspectives. Although it is widely regarded as a common source of low back pain, little consensus exists on the appropriate clinical management of sacroiliac joint pain and dysfunction. Understanding the biomechanics, innervation, and function of this complex load bearing joint is critical to formulating appropriate treatment algorithms for SI joint disorders. ASPN has developed this comprehensive practice guideline to serve as a foundational reference on the appropriate management of SI joint disorders utilizing the best available evidence and serve as a foundational guide for the treatment of adult patients in the United States and globally.

4.
Br J Anaesth ; 132(3): 575-587, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38199928

ABSTRACT

BACKGROUND: Breast cancer is the most common cancer among women and tumour resection carries a high prevalence of chronic persistent postsurgical pain (CPSP). Perioperative i.v. lidocaine infusion has been proposed as protective against CPSP; however, evidence of its benefits is conflicting. This review evaluates the effectiveness of perioperative lidocaine infusions for breast cancer surgery. METHODS: Randomised trials comparing perioperative lidocaine infusions with parenteral analgesia in breast cancer surgery patients were sought. The two co-primary outcomes were the odds of CPSP at 3 and 6 months after operation. Secondary outcomes included rest pain at 1, 6, 12, and 24 h; analgesic consumption at 0-24 and 25-48 h; quality of recovery; opioid-related side-effects; and lidocaine infusion side-effects. Hartung-Knapp-Sidik-Jonkman (HKSJ) random effects modelling was used. RESULTS: Thirteen trials (1039 patients; lidocaine: 518, control: 521) were included. Compared with control, perioperative lidocaine infusion did not decrease the odds of developing CPSP at 3 and 6 months. Lidocaine infusion improved postoperative pain at 1 h by a mean difference (95% confidence interval) of -0.65 cm (-0.73 to -0.57 cm) (P<0.0001); however, this difference was not clinically important (1.1 cm threshold). Similarly, lidocaine infusion reduced oral morphine consumption by 7.06 mg (-13.19 to -0.93) (P=0.029) over the first 24 h only; however, this difference was not clinically important (30 mg threshold). The groups were not different for any of the remaining outcomes. CONCLUSIONS: Our results provide moderate-quality evidence that perioperative lidocaine infusion does not reduce CPSP in patients undergoing breast cancer surgery. Routine use of lidocaine infusions for perioperative analgesia and CPSP prevention is not supported in this population. SYSTEMATIC REVIEW PROTOCOL: PROSPERO CRD42023420888.


Subject(s)
Anesthetics, Local , Breast Neoplasms , Chronic Pain , Lidocaine , Pain, Postoperative , Perioperative Care , Humans , Pain, Postoperative/prevention & control , Pain, Postoperative/drug therapy , Lidocaine/administration & dosage , Lidocaine/therapeutic use , Breast Neoplasms/surgery , Female , Anesthetics, Local/administration & dosage , Anesthetics, Local/therapeutic use , Chronic Pain/prevention & control , Chronic Pain/drug therapy , Perioperative Care/methods , Infusions, Intravenous , Treatment Outcome , Acute Pain/prevention & control , Acute Pain/drug therapy , Randomized Controlled Trials as Topic
5.
Biomedicines ; 11(4)2023 Apr 10.
Article in English | MEDLINE | ID: mdl-37189763

ABSTRACT

While denervation can occur with aging, peripheral nerve injuries are debilitating and often leads to a loss of function and neuropathic pain. Although injured peripheral nerves can regenerate and reinnervate their targets, this process is slow and directionless. There is some evidence supporting the use of neuromodulation to enhance the regeneration of peripheral nerves. This systematic review reported on the underlying mechanisms that allow neuromodulation to aid peripheral nerve regeneration and highlighted important in vivo studies that demonstrate its efficacy. Studies were identified from PubMed (inception through September 2022) and the results were synthesized qualitatively. Included studies were required to contain content related to peripheral nerve regeneration and some form of neuromodulation. Studies reporting in vivo highlights were subject to a risk of bias assessment using the Cochrane Risk of Bias tool. The results of 52 studies indicate that neuromodulation enhances natural peripheral nerve regeneration processes, but still requires other interventions (e.g., conduits) to control the direction of reinnervation. Additional human studies are warranted to verify the applicability of animal studies and to determine how neuromodulation can be optimized for the greatest functional restoration.

6.
Ergonomics ; 66(12): 2133-2147, 2023 Dec.
Article in English | MEDLINE | ID: mdl-36861457

ABSTRACT

Cognitive dissonance refers to a state where two psychologically inconsistent thoughts, behaviours, or attitudes are held at the same time. The objective of this study was to explore the potential role of cognitive dissonance in biomechanical loading in the low back and neck. Seventeen participants underwent a laboratory experiment involving a precision lowering task. To establish a cognitive dissonance state (CDS), study participants were provided negative feedback on their performance running counter to a pre-established expectation that their performance was excellent. Dependent measures of interest were spinal loads in the cervical and lumbar spines, calculated via two electromyography-driven models. The CDS was associated with increases to peak spinal loads in the neck (11.1%, p < .05) and low back (2.2%, p < .05). A greater CDS magnitude was also associated with a greater spinal loading increase. Therefore, cognitive dissonance may represent a risk factor for low back/neck pain that has not been previously identified.Practitioner summary: Upon establishing a cognitive dissonance state in a group of participants, spinal loading in the cervical and lumbar spines were increased proportional to the magnitude of the cognitive dissonance reported. Therefore, cognitive dissonance may represent a risk factor for low back and neck pain that has not been previously identified.


Subject(s)
Low Back Pain , Neck Pain , Humans , Neck Pain/etiology , Cognitive Dissonance , Spine , Lumbar Vertebrae , Low Back Pain/etiology , Electromyography , Biomechanical Phenomena
7.
Neuromodulation ; 26(1): 124-130, 2023 Jan.
Article in English | MEDLINE | ID: mdl-35367127

ABSTRACT

OBJECTIVES: Placement of percutaneous spinal cord stimulator (SCS) implant has become a therapeutic option for various chronic pain conditions; however, early surgical explant still occurs. Unfortunately, evidence regarding the incidence of early surgical explant, and patient-specific factors and comorbidities associated with such, is limited and mixed. The objective of this retrospective analysis was to elucidate the incidence and predictors of percutaneous SCS explant within the first two years of device placement. MATERIALS AND METHODS: The PearlDiver-Mariner Patient Record Database of all payer claims was used to identify patients who underwent percutaneous lead SCS implant (leads and generator) with subsequent explant within two years of initial device implant. The primary outcome was to determine the incidence of SCS explant within the first two years of device placement. Secondary outcomes included evaluating the effects of several patient-specific comorbidities on explant rates using univariate regression analysis. RESULTS: Across the database, a total of 52,070 patients who underwent percutaneous lead SCS implant were included, of whom 3104 (5.96%) had SCS explant within the first two years. Most explants occurred within the first-year time interval at 72.8% (2260 patients), whereas only 27.2% (844 patients) had SCS explant between years one and two. At the one-year time interval, covariates associated with an increased odds ratio (OR) (95% CI) of SCS explant were 1) depression (1.39 [1.26, 1.52]), 2) chronic preoperative (1.27 [1.16, 1.39]) or postoperative (1.23 [1,13, 1.36]) opioid use, 3) cannabis abuse (1.58 [1.20, 2.02]), 4) tobacco use (1.13 [1.04, 1.23]), and 5) coagulopathy (1.22 [1.07, 1.38]). In contrast, the OR of explant was lower in patients who were older, men, or had diabetes (complicated or uncomplicated). All associated covariates became nonsignificant after the first year of SCS implant (ie, between the first and second years), and only depression and tobacco use remained as associated factors for device explant. CONCLUSIONS: Our retrospective analysis highlights that the rate of percutaneous SCS explant appears to considerably decrease after the first year of device implant. Furthermore, this analysis sheds additional insights into patients who may be at risk of early percutaneous SCS explant, especially within the first year of device placement, and underscores the importance of a continued multidimensional/biopsychologic assessment in patients with chronic pain.


Subject(s)
Chronic Pain , Spinal Cord Stimulation , Male , Humans , Retrospective Studies , Chronic Pain/therapy , Spinal Cord Stimulation/adverse effects , Databases, Factual , Spinal Cord
8.
Hum Factors ; : 187208221120459, 2022 Sep 04.
Article in English | MEDLINE | ID: mdl-36059264

ABSTRACT

OBJECTIVE: The objective of this systematic review was to investigate the potential link between cognitive dissonance or its related constructs (emotional dissonance, emotional labor) and musculoskeletal disorders. BACKGROUND: The etiology of musculoskeletal disorders is complex, as pain arises from complex interactions among physical, social, and psychological stressors. It is possible that the psychological factor of cognitive dissonance may contribute to the etiology and/or maintenance of musculoskeletal disorders. METHOD: MEDLINE, APA PsycInfo, and CINAHL Plus databases were searched for studies investigating cognitive dissonance or its related constructs as exposure(s) of interest and outcomes related to physical health (including, but not limited to, musculoskeletal pain). Risk of bias was assessed using the Appraisal tool for Cross-Sectional Studies (AXIS) tool. RESULTS: The literature search yielded 7 studies eligible for inclusion. None of the included studies investigated cognitive dissonance directly but instead investigated dissonance-related constructs of emotional dissonance and emotional labor, in which a mismatch between required and felt emotions might elicit a psychological response consistent with the cognitive dissonance state. Moderate effect sizes between dissonance-related constructs and musculoskeletal disorders were noted (OR 1.25-2.22). CONCLUSION: There is likely a relationship between the two factors studied. However, as the included studies were cross-sectional in nature, a causal relationship between cognitive dissonance-related constructs and musculoskeletal disorders cannot be inferred. Therefore, future study proposing and validating a causal pathway between these variables is warranted. APPLICATION: Cognitive dissonance and its related constructs may serve as risk factors for musculoskeletal disorders that have not been considered previously.

9.
Front Med (Lausanne) ; 9: 975080, 2022.
Article in English | MEDLINE | ID: mdl-36045918

ABSTRACT

Background: Pectoralis nerve blocks (PECS) have been shown in numerous studies to be a safe and effective method to treat postoperative pain and reduce postoperative opioid consumption after breast surgery. However, there are few publications evaluating the PECS block effectiveness in conjunction with multimodal analgesia (MMA) in outpatient breast surgery. This retrospective study aims to evaluate the efficacy of PECS's blocks on perioperative pain management and opioid consumption. Methods: We conducted a retrospective study to assess the efficacy of preoperative PECS block in addition to preoperative MMA (oral acetaminophen and/or gabapentin) in reducing opioid consumption in adult female subjects undergoing outpatient elective breast surgery between 2015 and 2020. A total of 228 subjects were included in the study and divided in two groups: PECS block group (received PECS block + MMA) and control Group (received only MMA). The primary outcome was to compare postoperative opioid consumption between both groups. The secondary outcome was intergroup comparisons of the following: postoperative nausea and vomiting (PONV), incidence of rescue antiemetic medication, PACU non-opioid analgesic medication required, length of PACU stay and the incidence of 30-day postoperative complications between both groups. Results: Two hundred and twenty-eight subjects (n = 228) were included in the study. A total of 174 subjects were allocated in the control group and 54 subjects were allocated in the PECS block group. Breast reduction and mastectomy/lumpectomy surgeries were the most commonly performed procedures (48% and 28%, respectively). The total amount of perioperative (intraoperative and PACU) MME was 27 [19, 38] in the control group and 28.5 [22, 38] in the PECS groups (p = 0.21). PACU opioid consumption was 14.3 [7, 24.5] MME for the control group and 17 [8, 23] MME (p = 0.732) for the PECS group. Lastly, the mean overall incidence of postsurgical complications at 30 days was 3% (N = 5), being wound infection, the only complication observed in the PECS groups (N = 2), and hematoma (N = 2) and wound dehiscence (N = 1) in the control group. Conclusion: PECS block combined with MMA may not reduce intraoperative and/or PACU opioid consumption in patients undergoing outpatient elective breast surgery.

10.
Neuromodulation ; 2022 Aug 14.
Article in English | MEDLINE | ID: mdl-35977852

ABSTRACT

OBJECTIVES: Inadvertent dural puncture (IDP) is a known complication associated with traditional neuraxial procedures; however, its characterization after percutaneous spinal cord stimulation (SCS) lead placement has yet to be clearly established in large population studies. This retrospective analysis aims to understand the incidence and associated characteristics of patients with IDP after percutaneous SCS lead placement. MATERIALS AND METHODS: The PearlDiver Mariner database of national all-payer claims was used to identify patients who received percutaneous SCS leads and had a claim for IDP (intraoperative IDP or postdural puncture headache [PDPH] claim) within 45 days. The primary outcome was to determine the overall incidence of IDP. Secondary outcomes included an evaluation of associated risk factors for IDP and treatments used in symptomatic management. RESULTS: A total of 90,952 patients who underwent percutaneous lead SCS placement were included. The incidence of IDP was 0.48% (436/90,952 patients). Older age (odds ratio [OR]: 0.96; 95% CI: 0.95-0.97; p < 0.0001) and male sex (OR: 0.66; 95% CI: 0.53-0.81; p < 0.001) had a lower odds of having a claim for IDP, whereas a history of IDP was associated with a higher OR (95% CI) by 13.72 times (10.72-17.58) (p < 0.0001). Of the IDP patients, 64% (277/436 patients) had a claim for a therapeutic blood patch. Discrepancy in type of claim for IDP was observed, with most being for PDPH. CONCLUSIONS: Our findings suggest that IDP after percutaneous SCS lead placement is an uncommon event; however, certain factors are associated with its development. Overall, early recognition of IDP after percutaneous SCS lead placement is imperative to facilitate the delivery of targeted treatments and prevent further harmful consequences to the patient.

11.
Contemp Clin Trials ; 112: 106623, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34798295

ABSTRACT

BACKGROUND: Postoperative ileus (POI) is a common complication with no proven prophylactic measures in place. While perioperative opioid use has been implicated in POI development, current treatments fail to target this disease mechanism. Methylnaltrexone (MNTX) has been used to prevent the effects of opioids on the bowel and could reduce the incidence of POI when administered preoperatively. METHODS: In this phase IIb randomized controlled trial, we assessed the effect of perioperative MNTX on time-to-first-bowel movement following spinal arthrodesis surgeries. RESULTS: 82 patients were randomly selected in a 1:1 ratio to be included in either the treatment or placebo groups. Comparison of relevant factors of included patients to patients who refused to participate (n = 21) and to a prior retrospective series (n = 241) revealed no differences in age, male sex, liver disease, and number of surgical levels. Overall treatment fidelity (98% adherence) and retention (100% at one-month follow-up) were high. The predicted POI incidence (9.3-11.1%) was also equivalent to a prior retrospective series. However, the overall observed POI incidence (3.7%) was lower than expected, which could reflect a superimposed 'trial effect' related to standardized care in a research setting. CONCLUSIONS: Since exposure to significant opioid doses represents a barrier to enhanced recovery after surgery, the results of this innovative trial may provide further guidance for the peri-operative use of opioid-receptor blockers. Here, we show that MNTX can be effectively administered in the peri-operative period with appropriate follow-up achieved in a representative population of patients undergoing spinal surgery. TRIAL REGISTRATION NUMBERS: Clinicaltrials.gov - NCT03852524 and Institutional Review Board - 2018H0260.


Subject(s)
Ileus , Adult , Arthrodesis/adverse effects , Feasibility Studies , Humans , Ileus/epidemiology , Ileus/etiology , Ileus/prevention & control , Male , Naltrexone/analogs & derivatives , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Quaternary Ammonium Compounds , Retrospective Studies
12.
Spine J ; 22(3): 444-453, 2022 03.
Article in English | MEDLINE | ID: mdl-34419626

ABSTRACT

BACKGROUND CONTEXT: Postoperative ileus is a major barrier to gastrointestinal recovery following surgery. Opioid analgesics likely play an important causative role, particularly in spinal or orthopedic surgeries not involving bowel manipulation. Methylnaltrexone, a peripherally-acting µ-opioid receptor antagonist, is a potential prophylactic treatment. PURPOSE: To assess the influence of perioperative subcutaneous methylnaltrexone administration on gastrointestinal recovery following short-segment lumbar arthrodesis surgeries. DESIGN: This is a randomized, double-blind, controlled trial. PATIENT SAMPLE: Eligible patients undergoing posterior short-segment lumbar arthrodesis surgeries at a single institution between February 2019 and April 2021 were enrolled in this study. OUTCOME MEASURES: The primary outcome measure was time-to-first bowel movement. Secondary outcome measures included time-to-discharge/discharge eligibility. Exploratory outcome measures included daily postoperative opioid consumption and pain scores. METHODS: In this study, eligible patients were enrolled to receive either methylnaltrexone or placebo perioperatively. Time-to-bowel movement, time-to-discharge/discharge eligibility, intra and postoperative analgesic administration, and pain scores were recorded and compared. RESULTS: Eighty two patients in total were enrolled; 41 to the methylnaltrexone and 41 to the placebo group. Both groups were similar in their baseline characteristics. There was no difference in median (range) time-to-bowel movement between the 2 groups [61.8 hours (35.7-93.6) versus 50.7 hours (17.8-110.8), p = .391]. There was also no difference in time-to-discharge/discharge eligibility [105.0 hours (81.0 - 201.3) versus 90.7 (77.5 - 184.5), p=.784]. Finally, there were no differences in either postoperative opioid consumption or numeric rating scores for back, leg, or abdominal pain on postoperative days 0 to 4 (p>.05). CONCLUSIONS: Methylnaltrexone did not accelerate gastrointestinal recovery and did not affect opioid consumption or pain scores following short-segment spinal surgery as compared to placebo. Additional studies will be needed to identify effective opioid receptor antagonist dosing regimens for patients undergoing either short- or long-segment spinal arthrodesis procedures.


Subject(s)
Naltrexone , Quaternary Ammonium Compounds , Analgesics, Opioid/therapeutic use , Arthrodesis , Double-Blind Method , Humans , Naltrexone/adverse effects , Naltrexone/analogs & derivatives , Narcotic Antagonists/adverse effects , Pain, Postoperative/drug therapy , Quaternary Ammonium Compounds/adverse effects , Treatment Outcome
13.
Front Surg ; 8: 757269, 2021.
Article in English | MEDLINE | ID: mdl-34957201

ABSTRACT

Background: Recently formed ileostomies may produce an average of 1,200 ml of watery stool per day, while an established ileostomy output varies between 600-800 ml per day. The reported incidence of renal impartment in patients with ileostomy is 8-20%, which could be caused by dehydration (up to 50%) or high output stoma (up to 40%). There is a lack of evidence if an ileostomy could influence perioperative fluid management and/or surgical outcomes. Methods: Subjects aged ≥18 years old with an established ileostomy scheduled to undergo an elective non-ileostomy-related major abdominal surgery under general anesthesia lasting more than 2 h and requiring hospitalization were included in the study. The primary outcome was to assess the incidence of perioperative complications within 30 days after surgery. Results: A total of 552 potential subjects who underwent non-ileostomy-related abdominal surgery were screened, but only 12 were included in the statistical analysis. In our study cohort, 66.7% of the subjects were men and the median age was 56 years old (interquartile range [IQR] 48-59). The median time from the creation of ileostomy to the qualifying surgery was 17.7 months (IQR: 8.3, 32.6). The most prevalent comorbidities in the study group were psychiatric disorders (58.3%), hypertension (50%), and cardiovascular disease (41.7%). The most predominant surgical approach was open (8 [67%]). The median surgical and anesthesia length was 3.4 h (IQR: 2.5, 5.7) and 4 h (IQR: 3, 6.5), respectively. The median post-anesthesia care unit (PACU) stay was 2 h (IQR:0.9, 3.1), while the median length of hospital stay (LOS) was 5.6 days (IQR: 4.1, 10.6). The overall incidence of postoperative complications was 50% (n = 6). Two subjects (16.7%) had a moderate surgical wound infection, and two subjects (16.7%) experienced a mild surgical wound infection. In addition, one subject (7.6%) developed a major postoperative complication with atrial fibrillation in conjunction with moderate hemorrhage. Conclusions: Our findings suggest that the presence of a well-established ileostomy might not represent a relevant risk factor for significant perioperative complications related to fluid management or hospital readmission. However, the presence of peristomal skin complications could trigger a higher incidence of surgical wound infections.

14.
Medicine (Baltimore) ; 100(11): e24836, 2021 Mar 19.
Article in English | MEDLINE | ID: mdl-33725954

ABSTRACT

ABSTRACT: Anesthesiologists and surgeons have demonstrated a lack of familiarity with professional guidelines when providing care for surgical patients with a do-not-resuscitate (DNR) order. This substantially infringes on patient's self-autonomy; therefore, leading to substandard care particularly for palliative surgical procedures. The interventional nature of surgical procedures may create a different mentality of surgical "buy-in," that may unintentionally prioritize survivability over maintaining patient self-autonomy. While previous literature has demonstrated gains in communication skills with simulation training, no specific educational curriculum has been proposed to specifically address perioperative code status discussions. We designed a simulated standardized patient actor (SPA) encounter at the beginning of post-graduate year (PGY) 2, corresponding to the initiation of anesthesiology specific training, allowing residents to focus on the perioperative discussion in relation to the SPA's DNR order.Forty four anesthesiology residents volunteered to participate in the study. PGY-2 group (n = 17) completed an immediate post-intervention assessment, while PGY-3 group (n = 13) completed the assessment approximately 1 year after the educational initiative to ascertain retention. PGY-4 residents (n = 14) did not undergo any specific educational intervention on the topic, but were given the same assessment. The assessment consisted of an anonymized survey that examined familiarity with professional guidelines and hospital policies in relation to perioperative DNR orders. Subsequently, survey responses were compared between classes.Study participants that had not participated in the educational intervention reported a lack of prior formalized instruction on caring for intraoperative DNR patients. Second and third year residents outperformed senior residents in being aware of the professional guidelines that detail perioperative code status decision-making (47%, 62% vs 21%, P = .004). PGY-3 residents outperformed PGY-4 residents in correctly identifying a commonly held misconception that institutional policies allow for automatic perioperative DNR suspensions (85% vs 43%; P = .02). Residents from the PGY-3 class, who were 1 year removed the educational intervention while gaining 1 additional year of clinical anesthesiology training, consistently outperformed more senior residents who never received the intervention.Our training model for code-status training with anesthesiology residents showed significant gains. The best results were achieved when combining clinical experience with focused educational training.


Subject(s)
Clinical Competence/statistics & numerical data , Perioperative Care/psychology , Perioperative Medicine/education , Resuscitation Orders/psychology , Students, Medical/psychology , Adult , Anesthesiology/education , Female , Guideline Adherence/statistics & numerical data , Humans , Internship and Residency/statistics & numerical data , Knowledge , Male , Patient Simulation , Personal Autonomy , Problem-Based Learning , Surveys and Questionnaires
15.
Neuromodulation ; 24(3): 556-565, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33296127

ABSTRACT

BACKGROUND AND OBJECTIVES: Multiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients. The Vectors study evaluated whether there is significant sustained improvement in pain and functional outcomes when therapy is delivered using a standardized approach. MATERIALS AND METHODS: Vectors, a post-market, single-arm study evaluated the safety and efficacy of SCS with an implantable neurostimulator starting with 1 kHz stimulation, targeting the T9-T10 disc space following paresthesia mapping. Subjects with chronic intractable low back and leg pain (visual analogue scale [VAS] ≥ 50 mm) were enrolled. The primary endpoint was change in overall pain (VAS) at the three-month visit compared to baseline. Subjects were followed through 12 months. Secondary endpoints included changes in low back and leg pain, quality of life (European Quality of Life - Five Dimensions, EQ-5D-5L), disability (Oswestry Disability Index, ODI), individual subject goals, and subject satisfaction. RESULTS: There was a significant reduction in overall pain (VAS; 45.4 mm) through the three-month visit, which was sustained through 12 months. At 12 months, 79% of subjects had ≥50% improvement in at least one pain domain (overall, lowback or leg) with 85% of subjects reporting therapy satisfaction. There was a decrease in disability and an improvement in quality of life with 70% of subjects achieving a personal activity goal by the three-month visit. CONCLUSIONS: Long-term pain relief and improvement in quality of life and function were achieved when following a standardized workflow. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT03345472.


Subject(s)
Chronic Pain , Spinal Cord Stimulation , Chronic Pain/therapy , Humans , Pain Measurement , Quality of Life , Spinal Cord , Treatment Outcome , Workflow
16.
Anesthesiology ; 134(2): 147-164, 2021 02 01.
Article in English | MEDLINE | ID: mdl-33372953

ABSTRACT

BACKGROUND: Liposomal bupivacaine is purported to extend analgesia of peripheral nerve blocks when administered perineurally. However, evidence of the clinical effectiveness of perineural liposomal bupivacaine is mixed. This meta-analysis seeks to evaluate the effectiveness of perineural liposomal bupivacaine in improving peripheral nerve block analgesia as compared with nonliposomal local anesthetics. METHODS: The authors identified randomized trials evaluating the effectiveness of peripheral nerve block analgesic that compared liposomal bupivacaine with nonliposomal local anesthetics. The primary outcome was the difference in area under the receiver operating characteristics curve (AUC) of the pooled 24- to 72-h rest pain severity scores. Secondary outcomes included postoperative analgesic consumption, time to first analgesic request, incidence of opioid-related side effects, patient satisfaction, length of hospital stay, liposomal bupivacaine side effects, and functional recovery. AUC pain scores were interpreted in light of a minimal clinically important difference of 2.0 cm · h. RESULTS: Nine trials (619 patients) were analyzed. When all trials were pooled, AUC pain scores ± SD at 24 to 72 h were 7.6 ± 4.9 cm · h and 6.6 ± 4.6 cm · h for nonliposomal and liposomal bupivacaine, respectively. As such, perineural liposomal bupivacaine provided a clinically unimportant benefit by improving the AUC (95% CI) of 24- to 72-h pain scores by 1.0 cm · h (0.5 to 1.6; P = 0.003) compared with nonliposomal bupivacaine. Excluding an industry-sponsored trial rendered the difference between the groups nonsignificant (0.7 cm · h [-0.1 to 1.5]; P = 0.100). Secondary outcome analysis did not uncover any additional benefits to liposomal bupivacaine in pain severity at individual timepoints up to 72 h, analgesic consumption, time to first analgesic request, opioid-related side effects, patient satisfaction, length of hospital stay, and functional recovery. No liposomal bupivacaine side effects were reported. CONCLUSIONS: Perineural liposomal bupivacaine provided a statistically significant but clinically unimportant improvement in the AUC of postoperative pain scores compared with plain local anesthetic. Furthermore, this benefit was rendered nonsignificant after excluding an industry-sponsored trial, and liposomal bupivacaine was found to be not different from plain local anesthetics for postoperative pain and all other analgesic and functional outcomes. High-quality evidence does not support the use of perineural liposomal bupivacaine over nonliposomal bupivacaine for peripheral nerve blocks.


Subject(s)
Analgesia/methods , Anesthetics, Local/therapeutic use , Bupivacaine/therapeutic use , Nerve Block/methods , Pain Management/methods , Anesthetics, Local/administration & dosage , Bupivacaine/administration & dosage , Humans , Liposomes , Peripheral Nerves/drug effects , Treatment Outcome
17.
Br J Anaesth ; 125(4): 560-579, 2020 10.
Article in English | MEDLINE | ID: mdl-32703549

ABSTRACT

BACKGROUND: Continuous epidural infusion (CEI) is commonly used for labour analgesia, but concerns over potential motor block, second-stage labour complications, and ineffective analgesia in late labour have prompted examining intermittent epidural bolus (IEB) as an alternative. However, evidence comparing these modalities is conflicting. The meta-analysis evaluates the analgesic efficacy of CEI vs IEB. METHODS: Databases were searched for trials comparing CEI to IEB for labour analgesia. The two co-primary outcomes were risk of breakthrough pain and difference in area under the curve (AUC) for pain scores during the first 4 h post-epidural initiation. Local anaesthetic consumption, maternal outcomes (i.e. delivery mode, labour duration, and maternal satisfaction), and side-effects of epidural analgesia were also evaluated. Results were pooled using random-effects modelling. Trial sequential analysis (TSA) was used to evaluate evidence reliability. RESULTS: Twenty-seven studies (3133 patients) were analysed. Compared with CEI, IEB decreased risk of breakthrough pain by 38% (risk ratio [95% confidence interval {CI}] of 0.62 [0.48, 0.81]; P=0.0004; I2=47%; 1164 patients) and reduced AUC of pain during the 4 h interval by 32.9% (mean difference [95% CI] of -16.7 mm h-1 [-18.9, -14.4]; P<0.0001; 1638 patients). Intermittent epidural bolus enhanced maternal satisfaction, shortened labour duration, decreased motor block, and reduced local anaesthetic consumption. The difference between the two groups was not statistically significant for epidural side-effects or mode of delivery. The TSA indicated adequate power for reliable inferences. CONCLUSIONS: Intermittent epidural bolus provides improved labour pain control during the first 4 h after epidural initiation with less breakthrough pain. Moderate- to high-quality evidence of intermittent epidural bolus superiority support its use as a safe and effective continuous epidural infusion alternative for labour analgesia.


Subject(s)
Analgesia, Epidural/methods , Analgesia, Obstetrical/methods , Anesthetics, Local/administration & dosage , Anesthetics, Local/adverse effects , Anesthetics, Local/pharmacology , Female , Humans , Labor, Obstetric , Patient Satisfaction , Pregnancy
18.
Am J Ther ; 19(1): 11-5, 2012 Jan.
Article in English | MEDLINE | ID: mdl-20634672

ABSTRACT

Patients rank postoperative nausea and vomiting (PONV) in the top five most undesirable outcomes of surgery. Thirty percent of all surgical patients experience PONV. We conducted an economic study to determine the financial implications of providing surgical patients with PONV prophylaxis to increase patient satisfaction and minimize postoperative complications. Our main objective was to develop an economic model of PONV prophylaxis. We retrospectively reviewed all surgical cases who received care at our institution from June 2005 to June 2007 in which the surgical patient was billed for treatment of nausea and vomiting while in the hospital. The PONV risk factors for these patients were assessed as well as the revenue stream associated with those patients who returned to the hospital within 5 days with nausea and vomiting as their chief complaint. Of the total number of medical charts reviewed (56,532), 28 (1.57%) of 1783 patients who were billed for PONV while in the hospital returned to the hospital with PONV. The total billable charges for PONV for these returning patients were $83,674; the total reimbursements were $25,816 yielding a 31% reimbursement rate. The total hospital expenses were $24,123 yielding a net hospital profit of $1693 for treating these 28 patients. The average hospital cost and charge per antiemetic drug dose was $0.304 and $3.66, respectively. Using these figures, we determined that our hospital's net profit increases linearly with increased PONV prophylaxis administration. Our economic analysis shows that PONV prophylaxis is economically beneficial for the hospital when weighed against the expenses generated by treating patients returning to the hospital with PONV.


Subject(s)
Antiemetics/therapeutic use , Models, Economic , Postoperative Nausea and Vomiting/prevention & control , Antiemetics/economics , Cost-Benefit Analysis , Female , Hospital Costs , Humans , Male , Patient Satisfaction , Postoperative Nausea and Vomiting/economics , Reimbursement Mechanisms , Retrospective Studies , Risk Factors
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