Analgesic Effectiveness of Wound Infiltration with Bupivacaine Versus a Mixture of Bupivacaine with Tramadol for Postoperative Pain Management Among Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia at Dilla University Referal Hospital, 2023: A Double-Blind Randomized Controlled Trial

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Abstract Background Post-cesarean pain is among the principal problems with an incidence rate ranging from 25.5 to 80%. A variety of pain managing approaches have been used over the years, to manage post-cesarean pain, but none of them were free of adverse effects. Wound infiltration is a simple and feasible approach to managing post-cesarean pain. Despite its simplicity, the effectiveness of wound infiltration with a mixture of bupivacaine and tramadol is still unknown. Objective The study aims to compare the analgesic effectiveness of wound infiltration with bupivacaine versus a combination of bupivacaine with tramadol for postoperative pain management among parturients undergoing cesarean section under spinal anesthesia. Methodology: A double-blind, superiority-based, parallel, randomized controlled trial was conducted on 60 parturients. Parturients were randomized to take either bupivacaine (B = 30) or a combination of bupivacaine and tramadol (BT = 30). The homogeneity of variance was examined using Levine's test, and the normality was assessed using Shapiro-Wilk. The independent t-test and the Manny Whitney U test were used, respectively, for Parametric and non-parametric data. To assess the repeated measurements, a mixed linear model and general estimating equations were used. A p-value of below 0.05 is taken as Statistically significant. Result Totally 60 parturients were analyzed and no dropouts. The severity of pain in the 6th hour is 6 times greater in the B group in comparison to the BT Group (P = 0.001, OR = 6.289, CI = 2.097–18.858). The mean tramadol consumption was lesser in the BT group (140.00 ± 48.066 mg) than B group (175.00 ± 34.114 mg) min with a statistically significant mean difference of 10.761 (95% CI, 13.459 to 56.541), t (58) = 3.252, P = 0.002, (d = 0.839). The mean first analgesia request was higher in a mixture of tramadol and bupivacaine group, (Mean ± SD) (367.33 ± 50.099 min) than bupivacaine group (216.33 ± 68.744 min) with a statistically significant difference of 15.530 (95% CI, -182.087 to -119.913), t (58) = 5.6553, P = 0.001. Conclusion and recommendation: Wound infiltration with a combination of bupivacaine and tramadol is more effective than bupivacaine alone for postoperative analgesia for pregnant patients who underwent cesarean delivery under spinal anesthesia.

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