Randomized Clinical Trial of Gabapentin Versus Placebo for Pain After Sacrospinous Ligament Fixation.

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Citation: Female Pelvic Medicine & Reconstructive Surgery. 28(2):65-71, 2022 02 01.PMID: 35084369Institution: MedStar Washington Hospital CenterDepartment: Obstetrics and Gynecology/UrogynecologyForm of publication: Journal ArticleMedline article type(s): Journal Article | Randomized Controlled TrialSubject headings: *Ligaments | *Pain, Postoperative | Analgesics/tu [Therapeutic Use] | Double-Blind Method | Gabapentin | Humans | Ligaments/su [Surgery] | Pain Measurement | Pain, Postoperative/dt [Drug Therapy] | Pain, Postoperative/et [Etiology]Year: 2022Name of journal: Female pelvic medicine & reconstructive surgeryAbstract: CONCLUSIONS: Although a 2-week course of gabapentin did not significantly decrease overall pain with normal activity after a sacrospinous ligament fixation procedure, pain at rest was lower with gabapentin compared with placebo. Copyright (c) 2021 American Urogynecologic Society. All rights reserved.METHODS: This double-blinded, randomized, placebo-controlled trial compared 2 weeks of gabapentin (300 mg nightly for 3 days and then 300 mg twice a day for 11 days) versus identical-appearing placebo after a sacrospinous ligament fixation procedure. The primary outcome was participant-reported average pain during normal activity in the past 24 hours (score 0-10 on the validated Surgical Pain Scale) assessed on postoperative day (POD) 7. We also assessed average pain at rest and gluteal (buttocks) pain (score 0-10). We needed 17 participants per group to detect a 2.5-point difference in Surgical Pain Scale score with an SD of 2.6 (alpha = 0.05; power, 80%).OBJECTIVES: Given the risk of postoperative pain and specifically neuropathic gluteal pain after a sacrospinous ligament suspension, we conducted a randomized trial to compare a 2-week course of gabapentin versus placebo on postoperative pain after a sacrospinous ligament fixation.RESULTS: The final intention-to-treat analysis compared 19 (49%) in the gabapentin group versus 20 (51%) in the placebo group. Between the gabapentin and placebo groups, average pain (2.0 +/- 2.0 vs 3.4 +/- 2.8, P = 0.09, respectively) and gluteal pain (2.1 +/- 2.0 vs 3.4 +/- 2.4, P = 0.09) during normal activity on POD 7 were not significantly different. However, average pain at rest on POD 7 was lower with gabapentin (1.6 +/- 1.5 vs 3.2 +/- 2.6, P = 0.04).All authors: Dieter AA, Feliciano KM, Geller EJ, Willis-Gray M, Wu JMOriginally published: Female Pelvic Medicine & Reconstructive Surgery. 28(2):65-71, 2022 02 01.Fiscal year: FY2022Fiscal year of original publication: FY2022Digital Object Identifier: Date added to catalog: 2022-02-22
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Journal Article MedStar Authors Catalog Article 35084369 Available 35084369

CONCLUSIONS: Although a 2-week course of gabapentin did not significantly decrease overall pain with normal activity after a sacrospinous ligament fixation procedure, pain at rest was lower with gabapentin compared with placebo. Copyright (c) 2021 American Urogynecologic Society. All rights reserved.

METHODS: This double-blinded, randomized, placebo-controlled trial compared 2 weeks of gabapentin (300 mg nightly for 3 days and then 300 mg twice a day for 11 days) versus identical-appearing placebo after a sacrospinous ligament fixation procedure. The primary outcome was participant-reported average pain during normal activity in the past 24 hours (score 0-10 on the validated Surgical Pain Scale) assessed on postoperative day (POD) 7. We also assessed average pain at rest and gluteal (buttocks) pain (score 0-10). We needed 17 participants per group to detect a 2.5-point difference in Surgical Pain Scale score with an SD of 2.6 (alpha = 0.05; power, 80%).

OBJECTIVES: Given the risk of postoperative pain and specifically neuropathic gluteal pain after a sacrospinous ligament suspension, we conducted a randomized trial to compare a 2-week course of gabapentin versus placebo on postoperative pain after a sacrospinous ligament fixation.

RESULTS: The final intention-to-treat analysis compared 19 (49%) in the gabapentin group versus 20 (51%) in the placebo group. Between the gabapentin and placebo groups, average pain (2.0 +/- 2.0 vs 3.4 +/- 2.8, P = 0.09, respectively) and gluteal pain (2.1 +/- 2.0 vs 3.4 +/- 2.4, P = 0.09) during normal activity on POD 7 were not significantly different. However, average pain at rest on POD 7 was lower with gabapentin (1.6 +/- 1.5 vs 3.2 +/- 2.6, P = 0.04).

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