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Subcutaneous Bupivacaine Infiltration Is Not Effective to Support Control of Postoperative Pain in Paediatric Patients Undergoing Spinal Surgery.

ABSTRACT: Spinal deformity corrections in paediatric patients are long-lasting procedures involving damage to many tissues and long pain exposure; therefore, effective pain management after surgical treatment is an important issue. In this study, the effect of inclusion of local infiltration analgesia, as an integral part of the scheme in postoperative pain control, in children and adolescents, subjected to the spinal deformity correction procedure, was assessed. Thirty patients, aged 8 to 17 years, undergoing spinal deformity correction were divided into a study group, receiving a 0.25% bupivacaine solution before wound closure, and a control group (no local analgesic agent). Morphine, at the doses of 0.10 mg/kg of body weight, was administered to the patients when pain occurred. Pain scores, morphine administration, and bleeding were observed during 48 postoperative hours. The pain scores were slightly lower in a 0-4 h period in patients who received bupivacaine compared with those in the control group. However, no differences were observed in a longer period of time and in the total opioid consumption. Moreover, increasing bleeding was observed in the bupivacaine-treated patients (study group) vs. the control. Bupivacaine only modestly affects analgesia and, due to the increased bleeding observed, it should not to be part of pain control management in young patients after spinal deformity correction.

SUBMITTER: Danielewicz A

PROVIDER: S-EPMC8198662 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceLiposomal bupivacaine for pain relief is purported to last 3 days compared with 8 hours with standard bupivacaine. However, its effectiveness is unknown in truncal incisions for cardiothoracic or vascular operations.ObjectiveTo compare the effectiveness of single-administration standard bupivacaine vs liposomal bupivacaine in patients undergoing truncal incisions.Design, setting, and participantsThis randomized clinical trial enrolled patients undergoing sternotomy, thoracotomy, minithoracotomy, and laparotomy from a single cardiovascular surgery department in an academic medical center between November 2012 and June 2018. The study was powered to detect a Cohen effect size of 0.35 with a power of greater than 80%. Data analysis was performed from July to December 2018.InterventionPatients were randomized to standard bupivacaine or liposomal bupivacaine.Main outcomes and measuresPain was assessed over 3 postoperative days by the Numeric Rating Scale (NRS). Adjunctive opioids were converted to morphine equivalents units (MEU). NRS scores were compared using Wilcoxon rank-sum (3-day area under the curve) and 2-way nonparametric mixed models (daily scale score) to assess time-by-group interaction. Secondary outcomes included cumulative opioid consumption.ResultsA total of 280 patients were analyzed, with 140 in each group (single-administration standard bupivacaine vs liposomal bupivacaine). Mean (SD) age was 60.2 (14.4) years, and 101 of 280 patients (36%) were women. Irrespective of treatment assignment, pain decreased by a mean of approximately 1 point per day over 3 days (β = -0.87; SE = 0.11; mixed model regression P < .001). Incision type was associated with pain with patients undergoing thoracotomy (including minithoracotomy) reporting highest median (interquartile range [IQR]) pain scores on postoperative days 1 (liposomal vs standard bupivacaine, 6 [4-8] vs 5 [3-7]; P = .049, Wilcoxon rank-sum) and 2 (liposomal vs standard bupivacaine, 5 [4-7] vs 4 [2-6]; P = .003, Wilcoxon rank-sum) but not day 3 (liposomal vs standard bupivacaine, 3 [2-6] vs 3 [1-5]; P = .10, Wilcoxon rank-sum), irrespective of treatment group. Median (IQR) 3-day cumulative NRS was 12.0 (8.0-16.5) for bupivacaine and 13.5 (9.0-17.0) for liposomal bupivacaine (P = .15, Wilcoxon rank-sum) Furthermore, use of opioids was greater following liposomal bupivacaine compared with standard bupivacaine (median [IQR], 41.5 [21.3-73.8] MEU vs 33.0 [17.8-62.5] MEU; P = .03, Wilcoxon rank-sum). On multivariable analysis, no interaction by incision type was observed for mean pain scores or opioid use.Conclusions and relevanceIn this randomized clinical trial involving truncal incisions for cardiovascular procedures, liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 postoperative days.Trial registrationClinicalTrials.gov Identifier: NCT02111746.

Project description:ImportanceMost women report moderate to severe pain after cesarean delivery. The extent of the ability of surgical wound infiltration with local anesthetic agents during cesarean delivery for the reduction of postoperative pain is uncertain.ObjectiveTo examine the efficacy of single wound infiltration with bupivacaine and adrenaline during cesarean delivery for the reduction of postoperative pain.Design, setting, and participantsThis randomized clinical trial was conducted between January 25, 2018, and May 30, 2020, at a university teaching hospital in Afula, Israel. A total of 288 women with singleton pregnancy who were scheduled for a planned cesarean delivery at term were randomized to receive single wound infiltration with bupivacaine and adrenaline during cesarean delivery (intervention group) or no single wound infiltration (control group) at a 1:1 ratio.InterventionsIn the intervention group, the subcutaneous layer was infiltrated on both sides of the wound by a mixture of bupivacaine and adrenaline before wound closure. Other perioperative techniques were similar between the groups.Main outcomes and measuresThe primary outcome was mean pain intensity over the course of 24 hours after the operation, as measured by a visual analog scale (VAS) score ranging from 0 to 10 (with higher scores indicating greater pain intensity). To detect a mean (SD) reduction of 1 (3) points in the VAS score in the intervention group, 286 women were needed in total. Secondary outcomes included VAS score greater than 4 (indicating moderate pain) at 2 hours after the operation, use of rescue opioids, maternal satisfaction with the pain management procedure (using a scale of 1-5, with higher scores indicating greater satisfaction), duration of the operation, scar complications (hematoma, infection, and separation), and length of stay.ResultsAmong 288 women (mean [SD] age, 32.5 [5.1] years; all of Arab or Jewish ethnicity), 143 were randomized to the intervention group, and 145 were randomized to the control group. Demographic and obstetric variables were similar between groups. The primary outcome (VAS pain score) was significantly lower in the intervention group (mean [SD], 2.21 [0.56]) compared with the control group (mean [SD], 2.41 [0.73]; P = .02). In the intervention group, 11 women (7.7%) had a VAS score greater than 4 at 2 hours compared with 22 women (15.2%) in the control group (odds ratio, 0.47; 95% CI, 0.22-1.00; P = .05). In addition, compared with the control group, the intervention group had significantly lower postpartum use of rescue opioid analgesics (19 women [13.3%] vs 37 women [25.5%]; P = .009) and greater satisfaction with pain management (mean [SD] score, 4.65 [0.68] vs 4.44 [0.76]; P = .007). In the intervention vs control groups, duration of the operation, scar complications (hematoma, infection, or separation), and length of stay were comparable.Conclusions and relevanceIn this study, wound infiltration with a single administration of bupivacaine and adrenaline during cesarean delivery reduced postoperative pain and opioid use and may have improved maternal satisfaction with pain management. These findings suggest the technique is efficacious, safe, and easy to perform.Trial registrationClinicalTrials.gov Identifier: NCT03395912.

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Subcutaneous Bupivacaine Infiltration Is Not Effective to Support Control of Postoperative Pain in Paediatric Patients Undergoing Spinal Surgery.

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