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Randomized Controlled Trial
Efficacy of postoperative analgesia with duloxetine in posthemorrhoidectomy pain: a prospective, randomized, double-blind and placebo-controlled trial.
- Marlus Tavares Gerber, Humberto Fenner Lyra, Thomas Rolf Erdmann, Fernanda Bomfati, Patrick Barcelos Gaspareto, and Getúlio Rodrigues de Oliveira Filho.
- University Hospital, Federal University of Santa Catarina, Maria Flora Pausewang St. S/N Campus Universitário - Trindade, Florianopolis, Santa Catarina, 88036-800, Brazil. marlusgerber@yahoo.com.br.
- BMC Anesthesiol. 2022 Dec 1; 22 (1): 372372.
BackgroundTo evaluate the effect of duloxetine when added to a multimodal analgesia regimen on posthemorrhoidectomy pain, opioid consumption, and side effects.MethodsProspective, randomized, double-blind placebo-controlled trial. This study included 62 patients who underwent hemorrhoidectomy. The patients were randomly assigned to receive oral duloxetine 60 mg or placebo 2 h before and 24 h after surgery. The primary outcomes were pain intensity - measured on an 11-point visual analog pain scale - and cumulative morphine consumption at 12, 24, and 48 postoperative hours.ResultsFifty-two patients completed the study (25 in the duloxetine group and 27 in the placebo group). Pain scores did not differ between duloxetine and placebo: 4.5; 3.0 - 7.0 vs. 5.0; 3.5 - 7.0, p = 0.68 at 12 h, 3.0; 2.0 - 5.0 vs. 3.0; 2.0 - 5.0, p = 0.56 at 24 h, and 2.5; 1.75 - 3.75 vs. 1.5; 0.5 - 3, p = 0.08 at 48 h. Further, cumulative morphine consumption did not differ between the duloxetine and placebo groups: 4; 1.25 - 10.75 mg vs. 7; 1.0 - 12.0 mg, p = 0.68 at 12 h, 9.5; 2.0 - 17.5 mg vs. 8.0; 4.0 - 18.0 mg; p = 0.80 at 24 h, and 11.0; 2.0 - 27.0 mg vs. 10; 4.0 - 24.0 mg, p = 0.78 at 48 h. Side effects did not differ between the groups.ConclusionsCompared with placebo, duloxetine did not decrease pain intensity or morphine consumption during the first 48 h postoperatively.Trial RegistrationThe study was retrospectively registered on the Brazilian Clinical Trials Registry (identifier: RBR-9pdgms, registration date: 08/10/2020).© 2022. The Author(s).
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