Tramadol-paracetamol for postoperative pain after spine surgery - A randomized, double-blind, placebo-controlled study.

OBJECTIVES: Multimodal pain management is one component in enhanced recovery after surgery protocol. Here we evaluate the efficacy of tramadol-paracetamol in acute postoperative pain and pain outcome at 12 months after spine surgery in randomized, double-blind, placebo-controlled trial. METHODS: We randomized 120 patients undergoing spine surgery to receive, for add-on pain management, two tramadol-paracetamol 37.5 mg/325 mg (n = 61) or placebo tablets (n = 59) twice a day for 5 postoperative days. In the hospital, multimodal pain management consisted of dexketoprofen and oxycodone. After discharge, patients were prescribed ibuprofen 200 mg, maximum 1,200 mg/day. Pain, analgesic use, and satisfaction with pain medication were followed up with the Brief Pain Inventory questionnaire before surgery and at 1 and 52 weeks after surgery. The primary outcome was patients' satisfaction with pain medication 1 week after surgery. RESULTS: At 1 week after surgery, patients' satisfaction with pain medication was similarly high in the two groups, 75% [interquartile range, 30%] in the placebo group and 70% [40%] in the tramadol-paracetamol group (p = 0.949) on a scale: 0% = not satisfied, 100% = totally satisfied. At 1 week, ibuprofen dose was lower in the placebo group 200 mg [1,000] compared to the tramadol-paracetamol group, 800 mg [1,600] (p = 0.016). There was no difference in the need for rescue oxycodone. Patients in the tramadol-paracetamol group had more adverse events associated with analgesics during the first postoperative week (relative risk = 1.8, 95% confidence interval, 1.2-2.6). CONCLUSION: Add-on pain treatment with tramadol-paracetamol did not enhance patients' satisfaction with early pain management after back surgery.

A novel comparison of erector spinae plane block and paravertebral block in laparoscopic cholecystectomy.

OBJECTIVE: Erector spinae plane block is an updated method than paravertebral block, possessing a lower risk of complications. This study aimed to compare erector spinae plane and paravertebral blocks to safely reach the most efficacious analgesia procedure in laparoscopic cholecystectomy cases. METHODS: The study included 90 cases, aged 18-70 years, classified as American Society of Anesthesiologists I-II, who underwent an laparoscopic cholecystectomy procedure. They were randomly separated into three groups, namely, Control, erector spinae plane, and paravertebral block. No block procedure was applied to Control, and a patient-controlled analgesia device was prepared containing tramadol at a 10 mg bolus dose and a 10-min locked period. The pain scores were recorded with a visual analog scale for 24 h postoperatively. RESULTS: The visual analog scale values at 1, 5, 10, 20, and 60 min at rest and 60 min coughing were found to be significantly higher in Control than in paravertebral block. A significant difference was revealed between Control vs. paravertebral block and paravertebral block vs. erector spinae plane in terms of total tramadol consumption (p=0.006). Total tramadol consumption in the first postoperative 24 h was significantly reduced in the paravertebral block compared with the Control and erector spinae plane groups. CONCLUSION: Sonography-guided-paravertebral block provides sufficient postoperative analgesia in laparoscopic cholecystectomy surgery. Erector spinae plane seems to attenuate total tramadol consumption.

Post craniotomy pain management in Copenhagen rat by intraperitoneal or oral dosage of Tramadol: a comparative evaluation.

Calvarial craniotomy in animal models involves pain and distress. Moderate to severe pain in laboratory animals requires adequate pain management strategies. According to previous studies, the options available for suitable analgesia for rat calvarial craniotomy are very few. For most analgesic treatments, injectable routes of administration are predominantly used. However, these routes require restraining the animals, which may cause unnecessary pain, distress and suffering. As a well-fare measure, we focused on pain management by oral administration of analgesia. In this particular study, which is a sub-study of a major experiment on bone regeneration with different polymeric scaffold materials, we have compared the analgesic efficacy of intraperitoneal (I/P) and oral administration of tramadol (10 mg/kg) over a period of 96 h post-surgery in rat craniotomy models. The focus of our study is to evaluate the potential pain reduction efficacy of orally administered Tramadol without any restraining involved. We have used various non-invasive methods to assess the pain-alleviating efficacy of tramadol administered through different methods. We found that the efficacy of oral administration of tramadol is comparable to I/P administration in alleviating pain. Additionally, oral administration through drinking water has the benefit of not putting the animal under unwanted restraining stress.

The Role of Pharmacogenomics in Opioid Prescribing.

OPINION STATEMENT: Pharmacogenomics is increasingly important to guide objective, safe, and effective individualised prescribing. Personalised prescribing has revolutionised treatments in the past decade, allowing clinicians to maximise drug efficacy and minimise adverse effects based on a person's genetic profile. Opioids, the gold standard for cancer pain relief, are among the commonest medications prescribed in palliative care practice. This narrative review examines the literature surrounding opioid pharmacogenomics and its applicability to the palliative care cancer population. There is currently limited intersection between the fields of palliative care and pharmacogenomics, but growing evidence presents a need to build linkages between the two disciplines. Pharmacogenomic evidence guiding opioid prescribing is currently available for codeine and tramadol, which relates to CYP2D6 gene variants. However, these medications are prescribed less commonly for pain in palliative care. Research is accelerating with other opioids, where oxycodone (CYP2D6) and methadone (CYP2B6, ABCB1) already have moderate evidence of an association in terms of drug metabolism and downstream analgesic response and side effects. OPRM1 and COMT are receiving increasing attention and have implications for all opioids, with changes in opioid dosage requirements observed but they have not yet been studied widely enough to be considered clinically actionable. Current evidence indicates that incorporation of pharmacogenomic testing into opioid prescribing practice should focus on the CYP2D6 gene and its actionable variants. Although opioid pharmacogenomic tests are not widely used in clinical practice, the progressively reducing costs and rapid turnover means greater accessibility and affordability to patients, and thus, clinicians will be increasingly asked to provide guidance in this area. The upsurge in pharmacogenomic research will likely discover more actionable gene variants to expand international guidelines to impact opioid prescribing. This rapidly expanding area requires consideration and monitoring by clinicians in order for key findings with clinical implications to be accessible, meaningfully interpretable and communicated.

Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators.

Opioid prescribing for postoperative pain management is challenging because of inter-patient variability in opioid response and concern about opioid addiction. Tramadol, hydrocodone, and codeine depend on the cytochrome P450 2D6 (CYP2D6) enzyme for formation of highly potent metabolites. Individuals with reduced or absent CYP2D6 activity (i.e., intermediate metabolizers [IMs] or poor metabolizers [PMs], respectively) have lower concentrations of potent opioid metabolites and potentially inadequate pain control. The primary objective of this prospective, multicenter, randomized pragmatic trial is to determine the effect of postoperative CYP2D6-guided opioid prescribing on pain control and opioid usage. Up to 2020 participants, age ≥8 years, scheduled to undergo a surgical procedure will be enrolled and randomized to immediate pharmacogenetic testing with clinical decision support (CDS) for CYP2D6 phenotype-guided postoperative pain management (intervention arm) or delayed testing without CDS (control arm). CDS is provided through medical record alerts and/or a pharmacist consult note. For IMs and PM in the intervention arm, CDS includes recommendations to avoid hydrocodone, tramadol, and codeine. Patient-reported pain-related outcomes are collected 10 days and 1, 3, and 6 months after surgery. The primary outcome, a composite of pain intensity and opioid usage at 10 days postsurgery, will be compared in the subgroup of IMs and PMs in the intervention (n = 152) versus the control (n = 152) arm. Secondary end points include prescription pain medication misuse scores and opioid persistence at 6 months. This trial will provide data on the clinical utility of CYP2D6 phenotype-guided opioid selection for improving postoperative pain control and reducing opioid-related risks.

The Effect of Perianal Tramadol Infiltration on Postoperative Pain Following Hemorrhoidectomy.

INTRODUCTION: The present study was attempted to evaluate the effect of perianal infiltration of tramadol on postoperative pain in patients undergoing hemorrhoidectomy. METHOD: This double-blind clinical trial study was carried out on 90 patients with grade 3 and 4 hemorrhoids undergoing hemorrhoidectomy. Patients were randomly assigned into 3 groups of control or bupivacaine or tramadol. Before the surgery, perianal infiltration of .25% bupivacaine or tramadol or normal saline was prescribed to each group, respectively. Data on pain severity (based on the visual analog scale (VAS), the duration of surgery, sedation score, pain at the first defecation, first request time for additional analgesia, nausea and vomiting, and analgesic intakes) were evaluated and analyzed. RESULTS: Duration of surgery was almost similar in all 3 groups (P = .974). The results showed a significant difference in pain score between 3 groups (P ≤.05) at all times after the surgery. In addition, the means of sedation scores (P = .03), pain score at the first defecation (P = .001), the time to first analgesic request (P = .001), and ketorolac administration times (P = .01) were significantly different between 3 groups. Finally, no complication was reported regarding postoperative nausea and vomiting. CONCLUSION: Given the notable efficacy of tramadol in reducing pain after hemorrhoidectomy and its minor side effects, this medication is suggested as an effective topical anesthetic to decrease pain after hemorrhoidectomy.

Acupuncture against chronic postsurgical pain in non-small cell lung cancer patients: A protocol of randomized controlled trial.

INTRODUCTION: Video-assisted thoracoscopic lobectomy is the prior recommended treatment for non-small cell lung cancer (NSCLC), with the advantages of small trauma, less postoperative pain, and quick recovery. However, a large number of patients may suffer chronic postsurgical pain (CPSP), which makes the patients unwilling to practice pulmonary exercises, and it would directly affect patient's cough, sputum expectoration, and mobility. Opioids could greatly improve the quality of postoperative analgesia and the quality of life after surgery, but it is accompanied with obvious side effects. A number of clinical studies have proved that acupuncture could improve postoperative pain and reduce opioid use. In this study, we try to conduct a randomized controlled study to evaluate the efficacy and safety of plum-blossom needle acupuncture combined with Tramadol in improving CPSP after lobectomy in NSCLC patients. METHODS: Patients will be randomly divided into treatment group (acupuncture plus Tramadol) and control group (sham acupuncture plus Tramadol) with a random number table in 1:1 ratio. The patients, outcome assessor, and statistician will be blinded. The outcomes are changes of numerical rating scale, Karnofsky performance score, brief pain inventory, blood routine, liver and kidney function. The data will be analyzed by SPSS 22.0. CONCLUSIONS: The results will help to evaluate the efficacy and safety of plum-blossom needle acupuncture in improving CPSP after lobectomy in NSCLC patients.

Patient-Centered Decision-making for Postoperative Narcotic-Free Endocrine Surgery: A Randomized Clinical Trial.

Importance: Historically, opioid pain medications have been overprescribed following thyroid and parathyroid surgery. Many narcotic prescriptions are incompletely consumed, creating waste and opportunities for abuse. Objective: To determine whether limiting opioid prescriptions after outpatient thyroid and parathyroid surgery to patients who opt in to narcotic treatment reduces opioid consumption without increasing postoperative pain compared with usual care (routine narcotic prescriptions). Design, Setting, and Participants: A randomized clinical trial of Postoperative Opt-In Narcotic Treatment (POINT) or routine narcotic prescription (control) was conducted at a single tertiary referral center from June 1 to December 30, 2020. A total of 180 adults undergoing ambulatory cervical endocrine surgery, excluding patients currently receiving opioids, were assessed for eligibility. POINT patients received perioperative pain management counseling and were prescribed opioids only on patient request. Patients reported pain scores (0-10) and medication use through 7 daily postoperative surveys. Logistic regression was used to determine factors associated with opioid consumption. Interventions: Patients in the POINT group were able to opt in or out of receiving prescriptions for opioid pain medication on discharge. Control patients received routine opioid prescriptions on discharge. Main Outcomes and Measures: Daily peak pain score through postoperative day 7 was the primary outcome. Noninferiority was defined as a difference less than 2 on an 11-point numeric rating scale from 0 to 10. Analysis was conducted on the evaluable population. Results: Of the 180 patients assessed for eligibility, the final study cohort comprised 102 patients: 48 randomized to POINT and 54 to control. Of these, 79 patients (77.5%) were women and median age was 52 (interquartile range, 43-62) years. A total of 550 opioid tablets were prescribed to the control group, and 230 tablets were prescribed to the POINT group, in which 23 patients (47.9%) opted in for an opioid prescription. None who opted out subsequently required rescue opioids. In the first postoperative week, 17 POINT patients (35.4% of survey responders in the POINT group) reported consuming opioids compared with 27 (50.0%) control patients (P = .16). Median peak outpatient pain scores were 6 (interquartile range, 4-8) in the control group vs 6 (interquartile range, 5-7) in the POINT group (P = .71). In multivariate analysis, patients with a history of narcotic use were 7.5 times more likely to opt in (95% CI, 1.61-50.11; P = .02) and 4.8 times more likely to consume opioids (95% CI, 1.04-1.52; P = .01). Higher body mass index (odds ratio, 1.11; 95% CI, 1.01-1.23; P = .03) and highest inpatient postoperative pain score (odds ratio, 1.24; 95% CI, 1.04-1.52; P = .02) were also associated with opioid consumption. Conclusions and Relevance: In this trial, an opt-in strategy for postoperative narcotics reduced opioid prescription without increasing pain after cervical endocrine surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04710069.

Effect of erector spinae plane block on the postoperative quality of recovery after laparoscopic cholecystectomy: a prospective double-blind study.

BACKGROUND: Laparoscopic cholecystectomy is a common surgical procedure that frequently results in substantial postoperative pain. Erector spinae plane block (ESPB) has been shown to have beneficial postoperative analgesic effects when used as a part of multimodal analgesia. The aim of this study was to determine whether ESPB improves postoperative recovery quality in patients undergoing laparoscopic cholecystectomy. Evaluation of the effects of ESPB on postoperative pain, opioid consumption, and nausea and vomiting was the secondary objective. METHODS: In this prospective double-blind study, 82 patients undergoing laparoscopic cholecystectomy were randomised into one of two groups: a standard multimodal analgesic regimen in Group N (control) or an ESPB was performed in Group E. Preoperative and postoperative recovery quality was measured using the 40-item quality of recovery (QoR-40) questionnaire; postoperative pain was evaluated using the numerical rating scale scores. RESULTS: Postoperative mean (standard deviation) QoR-40 scores were higher in Group E (181 [7.3]) than in Group N (167 [11.4]); P<0.01. With repeated measures, a significant effect of group and time was demonstrated for the global QoR-40 score, P<0.01, indicating better quality of recovery in Group E. Pain scores were significantly lower in Group E than in Group N, both during resting and motion at T1-T8 times (P<0.01 at each time). The total amount of tramadol consumed in the first 24 h was lower in Group E [median 0 mg, inter-quartile range (IQR) (0-140)], than in Group N [median 180 mg, IQR (150-240); P<0.01]. CONCLUSIONS: ESPB improved postoperative quality of recovery in patients undergoing laparoscopic cholecystectomy. Moreover, ESPB reduced pain scores and cumulative opioid consumption. CLINICAL TRIAL REGISTRATION: NCT04112394.

The role of adenosine A1 receptor in the peripheral tramadol's effect in the temporomandibular joint of rats.

Peripheral tramadol's delivery in the temporomandibular joint (TMJ) leads to significant analgesic outcomes and inflammatory process's resolvent actions. Mechanistically, these properties are apart from the opioid system. Nevertheless, the molecular mechanisms behind these effects are still unclear. Therefore, the present study investigated the hypothesis that adenosine A1 receptors are involved in the tramadol-induced analgesic and anti-inflammatory effects in the TMJ. Animals were pretreated with an intra-TMJ injection of DPCPX (antagonist of A1 receptor) or tramadol and subsequent nociceptive challenge with an intra-TMJ injection of 1.5% formalin. For over 45 min, the nociceptive behavior was quantitated, and by the end of this assessment, the animals were euthanized, and the periarticular tissue was collected. Lastly, an in vitro assay of BMDM (Bone Marrow-Derived Macrophages) was performed to investigate tramadol activity in macrophages. The intra-TMJ injection of tramadol ameliorates formalin-induced hypernociception along with inhibiting leukocyte migration. The tramadol's peripheral anti-inflammatory effect was mediated by the adenosine A1 receptor and was associated with increased protein expression of α2a-adrenoceptor in the periarticular tissues (p < 0.05: ANOVA, Tukey's test). Also, tramadol inhibits formalin-induced leukocyte migration and protein expression of P2X7 receptors in the periarticular tissue (p < 0.05); however, DPCPX did not alter this effect (p > 0.05). Moreover, DPCPX significantly reduced the protein expression of the M2 macrophage marker, MRC1. In BMDM, tramadol significantly reduces inflammatory cytokines release, and DPCPX abrogated this effect (p < 0.05). We identify tramadol's peripheral effect is mediated by adenosine A1 receptor, possibly expressed in macrophages in the TMJ tissue. We also determined an important discovery related to the activation of A1R/α2a receptors in the tramadol action.

Intraocular pressure and pupil diameter in healthy cats anesthetized with isoflurane and pre-medicated with isolated acepromazine or in combination with tramadol / [Pressão intraocular e diâmetro pupilar em gatos saudáveis anestesiados com isoflurano e pré-medicados com acepromazina isolada ou em combinação com tramadol]

The objective of this study was to determine changes on intraocular pressure (IOP) and pupil diameter (PD) in healthy cats anesthetized with isoflurane, and premedicated with acepromazine alone or in combination with tramadol. Thirty cats were allocated in two groups (n=15/each) and were treated with acepromazine (AG) or acepromazine/tramadol (ATG). PD and IOP were assessed before and following 30 (PM1), and 40 minutes (PM2) of treatments. Anesthesia was induced with propofol, and IOP and DP were recorded (A10) at 10 minute intervals until the end of anesthesia (A40). IOP decreased in AG and ATG, when comparing baseline with PM1. IOP decreased only in AG, in comparisons between baseline and PM2. During anesthesia, IOP did not change within and between groups. Comparisons between baseline with those recorded at PM1 and 2 showed that PD increased in the ATG. During anesthesia, PD decreased significantly in AG and ATG. Both protocols maintained the IOP within the reference range to perform corneal or intraocular surgery in healthy cats but did not sustain pre-anesthetic pupil dilation observed in ATG.(AU)

O objetivo do presente artigo é determinar possíveis alterações na pressão intraocular (PIO) e no diâmetro pupilar (DP) em gatos saudáveis anestesiados com isoflurano e pré-medicados com acepromazina isolada ou em combinação com acepromazina/tramadol. Trinta gatos saudáveis foram distribuídos aleatoriamente em dois grupos (n=15/cada) e tratados com acepromazina (GA) ou acepromazina/tramadol (GAT). DP e PIO foram avaliadas antes (basal) e após 30 (PM1) e 40 minutos (PM2) dos tratamentos. A anestesia foi induzida com propofol, e a PIO e o DP foram registrados (A10) a cada 10 minutos até o final da anestesia com isoflurano (A40). Ao se compararem os valores obtidos no basal com PM1, a PIO diminuiu em GA e GAT; com PM2, a PIO reduziu apenas no GA. Durante a anestesia, a PIO não diferiu dentro e entre os grupos. Comparações entre os valores basais e os registrados em PM1 e em PM2 mostraram que a DP aumentou significativamente no GAT. Durante a anestesia, o DP diminuiu significativamente em GA e GAT. Ambos os protocolos mantêm a PIO dentro dos valores de referência para realizar cirurgias corneanas ou intraoculares em gatos saudáveis, mas não sustentam a dilatação pupilar pré-anestésica observada em GAT.(AU)

Factors affecting the effect of naldemedine for opioid-induced constipation: a single-institution, retrospective analysis.

Naldemedine is the newest orally available, peripherally selective µ-opioid receptor antagonist blocker approved for opioid-induced constipation (OIC) treatment in adult patients. On the other hand, some patients have insufficient OIC control even with naldemedine. Thus, this retrospective study was conducted to identify factors affecting the effect of naldemedine. The participants were 210 patients who had received naldemedine at our institute between June 2017 and August 2019. Variables associated with alleviation of OIC were extracted from clinical records and used for regression analysis. The effect of naldemedine was determined according to the degree of constipation. The degree of constipation was categorized as grade 0 - 2 with reference to the CTCAE version 5.0. Multivariate ordered logistic regression analysis was conducted to identify factors affecting the effect of naldemedine. Use of naldemedine within 2 days of opioid initiation [odds ratio (OR) =0.346, 95% confidence interval (CI) =0.173-0.693; P = 0.003], concomitant use of anticholinergics (OR = 2.033, 95% CI = 1.150-3.594; P = 0.015), tramadol (OR = 0.488, 95% CI = 0.250-0.953; P =0.036), and chronic non-cancer pain (OR = 0.429, 95% CI = 0.197-0.937; P = 0.034) were identified as significant factors related to the effect of naldemedine.

Ultrasound-Guided Thoracic Paravertebral Nerve Block on Postoperative Pain, Quality of Life, and Recovery in Patients with Non-Small-Cell Lung Cancer.

OBJECTIVES: Our study will investigate the effect of ultrasound-guided thoracic paravertebral block (UG-TPVB) on postoperative pain, quality of life, and enhanced recovery in patients with non-small-cell lung cancer (NSCLC) undergoing lobectomy surgery. METHODS: Our study included 100 patients aged 52 to 75 years who underwent lobectomy surgery with pathological diagnosis of NSCLC. Patients received ultrasound-guided thoracic paravertebral block or general anesthesia with tracheal intubation. Patients' pain score was recorded on a numeric rating scale (NRS) 24 hours post operation. The total postoperative dosage of tramadol hydrochloride, length of hospitalization, quality of life (QoL), and inflammation levels were recorded. RESULTS: Compared with patients who received general anesthesia with tracheal intubation, patients in the UG-TPVB group had lower postoperative NRS scores at 24 h (1.8 vs. 3.5, P = 0.035); the average 24 h postoperative NRS score of the UG-TPVB group is lower than that of the general anesthesia with tracheal intubation (4.6 vs. 5.3, P = 0.012), thus receiving less dosage of tramadol hydrochloride (221 ± 45 vs. 250 ± 38 mg, P < 0.01). Patients in the UG-TPVB group had better EORTC QLQ-C30 scores compared with patients in the general anesthesia with tracheal intubation group. The difference of length of hospitalization, hs-CRP, and IL-6 between two groups did not reach statistical difference (length of hospitalization 6.2 vs. 6.9 days, P = 0.055; hs-CRP: 7.1 ± 1.9 vs. 10.4 ± 6.6, P = 0.095; and IL-6: 71.3 ± 7.2 vs. 68.9 ± 8.7, P = 0.529). Discussion. NSCLC patients undergoing lobectomy surgery who received UG-TPVB had less postoperative pain, used less dosage of tramadol hydrochloride, and had better QoL.

The analgesic efficacy of ultrasound-guided transversus abdominis plane (TAP) block combined with oral multimodal analgesia in comparison with oral multimodal analgesia after caesarean delivery: a randomized controlled trial.

BACKGROUND: The transversus abdominis plane (TAP) block is used increasingly in parturients after caesarean delivery. This is a randomized controlled trial to evaluate the effectiveness of bilateral single-shot of TAP blocks in patients who received multimodal oral analgesia for postoperative pain relief. METHODS: Parturients who were scheduled for elective caesarean delivery under spinal anaesthesia were recruited and randomized to receive bilateral single-shot of TAP blocks or placebo in addition to multimodal oral analgesia which consisted of regular tramadol, celecoxib and paracetamol, with oral oxycodone used as a rescue for breakthrough pain. Only parturients in the TAP group would receive the TAP blocks with an injection of 15 ml (0.25%) ropivacaine on each side under aseptic techniques. All the parturients were evaluated for pain or related complications in the first 24 h after surgery. The primary outcome is the percentage of parturients who required oxycodone as a rescue analgesia. RESULTS: Eighty and 79 parturients were allocated to the TAP and placebo group respectively. Nine out of 79 (11.4%) parturients in the TAP group and 15 out of 73 (20.5%) parturients in the placebo group required oxycodone for breakthrough pain, P = 0.122. CONCLUSIONS: Bilateral single-shot of TAP blocks confer little additional benefit when a multimodal oral analgesic regimen is used for pain control after caesarean section under spinal anaesthesia. TRIAL REGISTRATION: Clinical Trial Registry of China ( http://www.chictr.org.cn ) identifier: ChiCTR-INR-16010130 , retrospectively registered on Dec 12, 2016.

Comparison between subarachnoid morphine and femoral nerve block for analgesia after knee ligament reconstruction: a randomized clinical trial / Comparação entre morfina subaracnoidea e bloqueio do nervo femoral para analgesia após reconstrução ligamentar de joelho: estudo clínico randomizado

Abstract Background and objectives There are no consensus of the ideal technique to provide analgesia in knee ligament reconstructions. The aim of this study was to compare the intensity of postoperative pain in these patients under different modalities of analgesia. Method Randomized and controlled clinical trial of patients undergoing reconstruction of the Anterior Cruciate Ligament (ACL) with flexor tendons between December 2013 and 2014. All patients underwent spinal anesthesia and rescue analgesia with tramadol. The groups C, M, R0,375 and R0,25 was compared with only the previously described technique, subarachnoid morphine (100░µg), or Femoral Nerve Block (BNF) with 25░mL of 0.375% ropivacaine and 0.25%, respectively. Pain intensity at 6, 12 and 24░hours, age, sex, rescue analgesia, adverse reactions and satisfaction were evaluated. Results Among the 83 eligible patients, a predominance of males (85.7%) was observed, between 28 and 31 years. The group C requested more opioid (27.3%) than the other groups, without significance when compared. There were no significant differences in pain intensity at 6, 12 and 24░hours. There was a higher incidence of urinary retention in the M group (23.8%) than in the R0,375 (0%) and prolonged quadriceps motor block in the R0,375 group (30%) than in the M and C groups (0%), with statistical significance (p░<░0.05). Conclusion There was no difference in the intensity of postoperative pain in patients submitted to ACL reconstruction with flexor tendons under the analgesic modalities evaluated, despite the predominance of urinary retention in the M group and motor block in the R0,375 group.

Resumo Justificativa e objetivos Não há consenso sobre qual é a técnica ideal para prover analgesia em reconstruções ligamentares de joelho. Objetivou‐se comparar a intensidade da dor pós‐operatória desses pacientes sob diferentes modalidades de analgesia. Método Ensaio clínico randomizado e controlado de pacientes submetidos à reconstrução do ligamento cruzado anterior com tendões flexores entre dezembro de 2013 e 2014. Todos os pacientes foram submetidos a raquianestesia e analgesia de resgate com tramadol. Compararam‐se os grupos C, M, R0,375 e R0,25; aos quais se ofertou apenas a técnica anteriormente descrita, morfina subaracnóidea (100 µg) ou bloqueio de nervo femoral com 25 mL de ropivacaína 0,375% e 0,25%, respectivamente. Avaliou‐se intensidade da dor em 6, 12 e 24 horas, idade, sexo, analgesia de resgate, reações adversas e satisfação. Resultados Entre os 83 pacientes elegíveis, observou‐se predomínio do sexo masculino (85,7%) entre 28 e 31 anos. O Grupo C solicitou mais opioide (27,3%) do que os demais grupos, sem significância quando comparados. Não houve diferenças significativas na intensidade da dor em 6, 12 e 24 horas. Houve maior incidência de retenção urinária no Grupo M (23,8%) do que no R0,375 (0%) e de bloqueio motor prolongado do quadríceps no Grupo R0,375 (30%) do que nos Grupos M e C (0%), com significância estatística (p< 0,05). Conclusão Não houve diferença na intensidade da dor pós‐operatória nos pacientes submetidos à reconstrução de ligamento cruzado anterior com tendões flexores sob as modalidades analgésicas avaliadas, apesar do predomínio de retenção urinária no Grupo M e bloqueio motor no Grupo R0,375.

[Comparison between subarachnoid morphine and femoral nerve block for analgesia after knee ligament reconstruction: a randomized clinical trial]. / Comparação entre morfina subaracnoidea e bloqueio do nervo femoral para analgesia após reconstrução ligamentar de joelho: estudo clínico randomizado.

BACKGROUND AND OBJECTIVES: There is no consensus of the ideal technique to provide analgesia in knee ligament reconstructions. The aim of this study was to compare the intensity of postoperative pain in these patients under different modalities of analgesia. METHOD: Randomized and controlled clinical trial of patients undergoing reconstruction of the anterior cruciate ligament (ACL) with flexor tendons between December 2013 and 2014. All patients underwent spinal anesthesia and rescue analgesia with tramadol. The Groups C, M, R0,375 and R0,25 were compared with only the previously described technique, subarachnoid morphine (100 µg) or femoral nerve block with 25 mL of 0.375% ropivacaine and 0.25%, respectively. Pain intensity at 6, 12 and 24hours, age, sex, rescue analgesia, adverse reactions and satisfaction were evaluated. RESULTS: Among the 83 eligible patients, a predominance of males (85.7%) was observed, between 28 and 31 years. The Group C requested more opioid (27.3%) than the other groups, without significance when compared. There were no significant differences in pain intensity at 6, 12 and 24hours. There was a higher incidence of urinary retention in the Group M (23.8%) than in the R0,375 (0%) and prolonged quadriceps motor block in the R0,375 Group (30%) than in the M and C Groups (0%), with statistical significance (p < 0.05). CONCLUSION: There was no difference in the intensity of postoperative pain in patients submitted to anterior cruciate ligament reconstruction with flexor tendons under the analgesic modalities evaluated, despite the predominance of urinary retention in the M Group and motor block in the R0,375 Group.

Pain management after ambulatory surgery: a prospective, multicenter, randomized, double-blinded parallel controlled trial comparing nalbuphine and tramadol.

BACKGROUND: Postoperative pain in ambulatory surgery is a multifactorial issue affecting patient satisfaction, time of discharge, and rehospitalization. This study evaluated the efficacy and safety of nalbuphine for the treatment of postoperative pain after ambulatory surgery, relative to tramadol. METHODS: This multi-center, randomized, double blind, and controlled study was conducted at 10 centers. In accordance with the inclusion criteria, 492 ambulatory surgery patients were recruited. These patients had moderate to severe pain after ambulatory surgery, with a visual analogue scale (VAS) score > 3 cm. They were randomly divided into an experimental (n = 248) or control (n = 244) group and treated for analgesia with 0.2 mg/kg of nalbuphine or 2 mg/kg of tramadol, respectively. VAS scores, adverse events, and vital signs of the patients were recorded before administration (baseline; T1); and 30 min (T2), 2 h (T3), 4 h (T4), and 6 h (T5) after administration of analgesia. A decrease in pain intensity of more than 25% compared with the baseline was used as an indicator of analgesic efficacy. The experimental and control groups were compared with regard to this indicator of efficacy at each timepoint. RESULTS: The VAS scores of the experimental and control groups were statistically comparable at timepoints T1-T4. At T5, the VAS scores of the experimental group were significantly lower than that of the control. The pain intensity was significantly higher in the experimental group compared with the control at T2 and T3. Adverse events and vital signs were similar for the two groups at each timepoint. CONCLUSIONS: Nalbuphine can provide effective and safe pain relief in patients after ambulatory surgery. TRIAL REGISTRATION: The registration number is ChiCTR-IOR-16010032 , the date of registration was 2016-11-28.

Comparison of preemptive paracetamol, paracetamol-diclofenac & paracetamol-tramadol combination on postoperative pain after elective abdominal surgery under general anesthesia, Ethiopia: a randomized control trial study, 2018.

BACKGROUND: In the practice of postoperative pain management, pain is still poorly managed in low resource setting where the practice of epidural and opioid free analgesia is impractical. There has been a recent trend of combining different drugs and concept of preemptive analgesia but the therapeutic superiority remains understudied for postoperative pain management. The aim of this study is to assess postoperative analgesic effect of preemptive Paracetamol, Paracetamol-diclofenac and Paracetamol-tramadol combination in patients undergoing laparotomy surgery. METHODS: Three-arm, randomized control trial study conducted on 63 patients undergone laparotomy surgery; group-P (paracetamol 1 g), group-PD (1 g + diclofenac 75 mg) and group-PT (paracetamol 1 g + tramadol 100 mg). The Numerical Rating Scale (NRS) pain rating system was used for this study. The primary endpoint of the study was total amount of analgesia consumption. Post-operative analgesic therapy [intravenous tramadol, 50 mg] were provided when patients complain of pain (request medication) or a numeric rating scale ≥4 was recorded. Secondary endpoint of the study were the time of first analgesic request and the intensity of the pain during 24 h post-op follow up period. Parametric data were analyzed using (ANOVA) and nonparametric data analyzed by Kuruska-Wallis H rank test. Chi-square test used for categorical variable. Statistical significance were sated at p value < 0.05 with a power of 80%. RESULTS: The mean total tramadol consumption was significant higher in paracetamol group 250 ± 79.06 mg compared to paracetamol-diclofenac (173.81 ± 87.49 mg p = 0. 008) and paracetamol-tramadol (154.76 ± 70.54 mg p = 0. 001) group. Time to first analgesic request was significantly shorter within paracetamol group (87.62 ± 20.95 min) compared to paracetamol-diclofenac (103.01 ± 23.53 min p = 0.029) and paracetamol-tramadol (144.05 ± 14.72 min p < 0.001) group. There was statistically significant difference at 4th, 6th and 8th hour showing lower median pain score in paracetamol-tramadol group compared to paracetamol group. CONCLUSION: Preemptive combination of paracetamol-tramadol and paracetamol-diclofenac reduce total tramadol consumption and prolongs time to first analgesic request compared to paracetamol alone in patients undergoing laparotomy surgery. TRIAL REGISTRATION: The study was retrospectively registered on 07 July 2019 at Pan African Clinical Trial Registry with the identification number of PACTR201908890749145 . It was accepted on 14 August 2019.

Comparison of preincisional and postincisional parasternal intercostal block on postoperative pain in cardiac surgery.

BACKGROUND: The optimum cardiac surgical pain management has known to maintain hemodynamic stability and, reduces respiratory and cardiovascular complications. Postoperative parasternal intercostal block has shown to reduce postoperative analgesic consumption after cardiac surgery. Therefore, this study sought to investigate the effectiveness of the preoperative ultrasound guided parasternal block in reducing postoperative pain after cardiac surgery. METHODS: This was a randomized, prospective, interventional, single blind study comprised of 90 adult patients scheduled for cardiac surgery involving sternotomy. Preoperatively and postoperatively, 0.25% bupivacaine administered in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under ultrasound guidance and direct vision, respectively. Postoperative pain was rated according to visual analogue scale. Secondary outcomes included intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation. MAIN RESULTS: There was no significant differences in visual analogue score visual analogue score at all time points till 24 hours postoperatively. Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72; P = .0001). Furthermore, there were no significant difference in total fentanyl requirement (7.20 ± 2.66 vs 8.37 ± 3.13; P = .06) and tramadol requirement (0.02 ± 0.15 vs 0.07 ± 0.26; P = .28) within first 24 hours. However, time to extubation was significantly higher in the preoperative group (P = .02). CONCLUSIONS: Preoperative and postoperative parasternal intercostal block provide comparable pain relief during the postoperative period.

Pharmacokinetics and analgesic efficacy of intranasal administration of tramadol in dogs after ovariohysterectomy.

OBJECTIVE: To assess analgesic efficacy and the pharmacokinetics of intranasal (IN) tramadol in dogs following ovariohysterectomy. STUDY DESIGN: Randomized, blinded clinical study. ANIMALS: A total of 30 bitches undergoing elective ovariohysterectomy. METHODS: Dogs were randomly assigned to one of three experimental groups (10 dogs per group): IN tramadol 4 mg kg-1 (group T-IN), intravenous (IV) tramadol 4 mg kg-1 (group T-IV) and IV methadone 0.2 mg kg-1 (group M). Drugs were administered at extubation. At established time points (before surgery and up to 8 hours after drug administration) analgesia was assessed using the Italian version of the Glasgow Composite Measure Pain Scale Short Form and physiological variables were recorded. To determine the pharmacokinetics of IN tramadol, blood samples were collected at predetermined time points. Shapiro-Wilk test was used to assess whether data were normally distributed and consequently parametric or non parametric tests were applied. A p value < 0.05 was considered significant. RESULTS: No significant intergroup differences were observed in the dogs that were administered rescue analgesia and time of its administration. Excluding dogs that were administered rescue analgesia, no significant intergroup differences emerged in pain scores and physiological variables, except for a lower rectal temperature in group M compared with the tramadol groups. After IN administration, tramadol was rapidly absorbed into the systemic circulation, reaching its maximum concentration (range 74.74-200.29 ng mL-1) within 30-60 minutes, it then decreased rapidly and was detectable in plasma for up to 2 hours after treatment in all dogs. CONCLUSIONS AND CLINICAL RELEVANCE: IN tramadol administration appears to be as effective as IV tramadol and methadone treatments in pain management of dogs after elective ovariohysterectomy. Given its low concentrations and short detection time in plasma after the IN route, systemic tramadol action appears unlikely.