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The Quality of Recovery after Dexamethasone, Ondansetron, or Placebo Administration in Patients Undergoing Lower Limbs Orthopedic Surgery under Spinal Anesthesia Using Intrathecal Morphine. A Randomized Controlled Trial.

ABSTRACT: Intrathecal morphine is widely and successfully used to prevent postoperative pain after orthopedic surgery, but it is frequently associated with side effects. The aim of this study was to evaluate the effect of dexamethasone or ondansetron when compared to placebo to reduce the occurrence of these undesirable effects and, consequently, to improve the quality of recovery based on patient's perspective. Methods. One hundred and thirty-five patients undergoing lower extremity orthopedic surgery under spinal anesthesia using bupivacaine and morphine were randomly assigned to receive IV dexamethasone, ondansetron, or saline. On the morning following surgery, a quality of recovery questionnaire (QoR-40) was completed. Results. No differences were detected in the global and dimensional QoR-40 scores following surgery; however, following postanesthesia care unit (PACU) discharge, pain scores were higher in patients receiving ondansetron compared with patients who received dexamethasone. Conclusion. Neither ondansetron nor dexamethasone improves the quality of recovery after lower limbs orthopedic surgery under spinal anesthesia using intrathecal morphine.

SUBMITTER: Moro ET

PROVIDER: S-EPMC7256731 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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The Quality of Recovery after Dexamethasone, Ondansetron, or Placebo Administration in Patients Undergoing Lower Limbs Orthopedic Surgery under Spinal Anesthesia Using Intrathecal Morphine. A Randomized Controlled Trial.

Moro Eduardo Toshiyuki ET Ferreira Miguel Antônio Teixeira MAT Gonçalves Renyer Dos Santos RDS Vargas Roberta Costa RC Calil Samira Joverno SJ Soranz Maria Alice MA Bloomstone Joshua J

Anesthesiology research and practice 20200520

Intrathecal morphine is widely and successfully used to prevent postoperative pain after orthopedic surgery, but it is frequently associated with side effects. The aim of this study was to evaluate the effect of dexamethasone or ondansetron when compared to placebo to reduce the occurrence of these undesirable effects and, consequently, to improve the quality of recovery based on patient's perspective. <i>Methods</i>. One hundred and thirty-five patients undergoing lower extremity orthopedic sur ...[more]

PMID: 32518560

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Project description:BackgroundPosterior spinal fusion for scoliosis is one of the most painful elective pediatric surgeries. Good postoperative pain control allows early ambulation and return of ability to tolerate oral intake. Options for analgesia in this patient population are suboptimal. We hypothesized that extended-release epidural morphine (EREM) would provide better pain control and less adverse effects compared to intrathecal (IT) morphine.MethodsThe primary outcome was total IV morphine consumption during 0-48 hours postoperatively. Secondary outcomes included time until first patient-controlled analgesia (PCA) demand, pain scores, and adverse opioid effects. After institutional review board approval, 71 subjects undergoing posterior spinal fusion for idiopathic scoliosis completed the study. The subjects were randomly allocated to 7.5 μg/kg IT morphine or 150 μg/kg EREM. The final IT morphine and EREM groups contained 37 and 34 subjects, respectively. Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen. Morphine consumption, pain scores, nausea and vomiting, pruritus, and respiratory depression were measured every 4 hours. Parents completed a caregiver questionnaire about their child's pain control regimen after the first postoperative day.ResultsThere was no difference in total morphine consumption over the first 48 hours between subjects in the EREM and IT morphine groups: median (range) 42.2 (5.5-123.0) and 34.0 (4.5-128.8) mg, respectively (P = .27). EREM and IT morphine groups had no difference in time until first PCA demand. Pain scores were no different between the groups from 8 to 24 hours after surgery. Compared to IT morphine, EREM subjects had lower pain scores from 28 to 36 hours after surgery. The reported incidence of pruritus was lower in the EREM subjects.ConclusionsThere was no difference in total morphine consumption or time until first PCA demand between the EREM and IT morphine groups. EREM provides a longer duration of analgesia after posterior spinal fusion for scoliosis and may be associated with less opioid-induced pruritus.

Project description:Study objectiveThis study's purpose was to determine if ondansetron can prevent pruritus after administration of intrathecal morphine in children, as has been demonstrated in adults.DesignA double-blinded, randomized placebo-controlled trial.SettingOperating room and first 24 h postoperative inpatient stay at an academic children's hospital.PatientsForty-six children aged 3-17 years, who received 4-5 mcg/kg intrathecal morphine for urological or orthopedic procedures were included.InterventionsChildren were randomized to receive intravenous ondansetron (treatment) or saline placebo (placebo), prior to intrathecal morphine administration, and q6H for 24 h thereafter. Intraoperative anti-emetics and postoperative rescue treatments for pruritus and nausea were standardized.MeasurementsPatients were interviewed q6H for scored pruritus, nausea, and pain, using standardized scales.Main resultsThe trial was terminated for futility after interim analysis. Forty-six children were recruited and 45 completed data collection. No significant difference was found between both groups for incidence of pruritus (requiring treatment) [relative risk (RR) 0.9, 95% CI: 0.7, 1.2], during the first postoperative 24 h. Notably, the incidence of pruritus was 84% overall, much higher than rates in previously published studies. Intravenous ondansetron significantly reduced the incidence of nausea, compared with the placebo group [RR 0.5, 95% CI: 0.3, 0.9].ConclusionsThis study found no evidence for intravenous ondansetron as an effective preventative for pruritus following intrathecal morphine in children. However, this RCT did find that the rate of pruritus following intrathecal morphine administration may be significantly higher than previously thought. Nausea and vomiting (a secondary outcome) were reduced significantly in the treatment group. The negative findings of this study reinforce the potential dangers of extrapolating the drug effects seen in adults onto pediatric patients.

Project description:BackgroundThe primary goal of this study was to determine whether administration of intrathecal morphine reduces postoperative pain. The secondary goal was to determine the effect of intrathecal morphine upon circulating levels of the weakly analgesic endocannabinoids, anandamide (AEA) and 2-arachidonoylglycerol (2-AG), and the related lipids palmitoylethanolamide (PEA) and oleoylethanolamide (OEA).MethodsForty two total knee arthroplasty (TKA) patients were enrolled in a prospective, double-blinded, randomized study. The intervention consisted of intrathecal morphine (200 μg) or placebo administered at the time of the spinal anesthesia. Postoperative pain was measured during the first 4 h after surgery while serum levels of AEA, 2-AG, PEA, OEA, and cortisol were measured at baseline and 4 h after surgery.ResultsAdministration of intrathecal morphine reduced postoperative pain 4 h after TKA surgery compared to placebo (p = 0.005) and reduced postoperative systemic opioid consumption (p = 0.001). At baseline, intrathecal morphine led to a significant reduction in AEA, 2-AG, and OEA levels but did not affect PEA or cortisol levels. In patients administered intrathecal placebo, 2-AG levels were elevated 4 h after surgery; whereas patients receiving intrathecal morphine showed reductions in AEA, PEA, and OEA when compared to placebo. At 4 h after TKA surgery cortisol levels were significantly elevated in the placebo group and reduced in those receiving morphine.ConclusionsThese results indicate that intrathecal morphine reduces postoperative pain in TKA patients. Furthermore, activation of central opioid receptors negatively modulates the endocannabinoid tone, suggesting that potent analgesics may reduce the stimulus for production of peripheral endocannabinoids. This study is the first to document the existence of rapid communication between the central opioid and peripheral endocannabinoid systems in humans.Trial registrationThis trial was registered retrospectively.Trial registryNCT02620631 . Study to Examine Pain Relief With Supplemental Intrathecal Morphine in TKA Patients, NCT02620631 , 12/03/2015.

Project description:BackgroundIntrathecal opioids are routinely administered during spinal anesthesia for postcesarean analgesia. The effectiveness of intrathecal morphine for postcesarean analgesia is well established, and the use of intrathecal hydromorphone is growing. No prospective studies have compared the effectiveness of equipotent doses of intrathecal morphine versus intrathecal hydromorphone as part of a multimodal analgesic regimen for postcesarean analgesia. The authors hypothesized that intrathecal morphine would result in superior analgesia compared with intrathecal hydromorphone 24 h after delivery.MethodsIn this single-center, double-blinded, randomized trial, 138 parturients undergoing scheduled cesarean delivery were randomized to receive 150 µg of intrathecal morphine or 75 µg of intrathecal hydromorphone as part of a primary spinal anesthetic and multimodal analgesic regimen; 134 parturients were included in the analysis. The primary outcome was the numerical rating scale score for pain with movement 24 h after delivery. Static and dynamic pain scores, nausea, pruritus, degree of sedation, and patient satisfaction were assessed every 6 h for 36 h postpartum. Total opioid consumption was recorded.ResultsThere was no significant difference in pain scores with movement at 24 h (intrathecal hydromorphone median [25th, 75th] 4 [3, 5] and intrathecal morphine 3 [2, 4.5]) or at any time point (estimated difference, 0.5; 95% CI, 0 to 1; P = 0.139). Opioid received in the first 24 h did not differ between groups (median [25th, 75th] oral morphine milligram equivalents for intrathecal hydromorphone 30 [7.5, 45.06] vs. intrathecal morphine 22.5 [14.0, 37.5], P = 0.769). From Kaplan-Meier analysis, the median time to first opioid request was 5.4 h for hydromorphone and 12.1 h for morphine (log-rank test P = 0.200).ConclusionsAlthough the hypothesis was that intrathecal morphine would provide superior analgesia to intrathecal hydromorphone, the results did not confirm this. At the doses studied, both intrathecal morphine and intrathecal hydromorphone provide effective postcesarean analgesia when combined with a multimodal analgesia regimen.

Dataset Information

The Quality of Recovery after Dexamethasone, Ondansetron, or Placebo Administration in Patients Undergoing Lower Limbs Orthopedic Surgery under Spinal Anesthesia Using Intrathecal Morphine. A Randomized Controlled Trial.

Publications

The Quality of Recovery after Dexamethasone, Ondansetron, or Placebo Administration in Patients Undergoing Lower Limbs Orthopedic Surgery under Spinal Anesthesia Using Intrathecal Morphine. A Randomized Controlled Trial.

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