Effect of port-site and intraperitoneal local anesthetic injection versus placebo on postoperative pain and recovery after gynecologic laparoscopic surgery: a randomized controlled trial

腹腔镜手术后,切口部位和腹腔内局部麻醉注射与安慰剂对术后疼痛和恢复的影响:一项随机对照试验

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Abstract

Laparoscopic gynecological surgery, while minimally invasive, is frequently associated with significant postoperative pain requiring systemic analgesics. Local anesthetic administration, either intraperitoneally or at trocar sites, has been proposed to improve analgesia and recovery, but evidence remains inconsistent. To evaluate and compare the efficacy of intraperitoneal and port-site local anesthetic injection versus placebo in reducing postoperative pain and improving recovery outcomes in women undergoing gynecological laparoscopic surgery. This randomized, double-blind, three-arm controlled trial enrolled 90 women aged 18-60 years undergoing elective gynecological laparoscopy at Kasr Al-Ainy Hospital, Cairo, Egypt (March 2024-March 2025; ClinicalTrials.gov NCT07030647). Participants were randomized into: Group A (trocar site bupivacaine 0.25%), Group B (intraperitoneal bupivacaine 0.25%), and Group C (saline placebo). Postoperative pain was assessed using a visual analog scale (VAS) at 1, 6, 12, and 24 h. Secondary outcomes included rescue diclofenac use, time to first analgesic, total diclofenac dose, time to ambulation, hospital stay, and patient satisfaction. Baseline demographics were comparable across groups. Group B reported the lowest pain scores at 1, 6, and 12 h (0.1 ± 0.3; 2.9 ± 1.1; 2.1 ± 0.3, respectively), followed by Group A, while Group C had the highest (p < 0.001). At 24 h, pain scores were similar (p = 0.087). Diclofenac requirement was significantly reduced in Group B (26.7%) compared to Groups A (83.3%) and C (100%) (p < 0.001). Time to first rescue analgesic was longest in Group B (7.1 ± 1.1 h vs. 2.9 ± 0.7 and 1.5 ± 0.8; p < 0.001). Total 24-hour diclofenac consumption was lowest in Group B (75 mg) versus Groups A (114 ± 38.2 mg) and C (142.5 ± 22.9 mg; p < 0.001). Early ambulation occurred fastest in Group B (3.5 ± 0.9 h), followed by Group A (5.1 ± 0.6 h) and Group C (6.9 ± 0.8 h; p < 0.001). Hospital stay was 24 h in all groups. Patient satisfaction was highest in Group B (7.3 ± 1.2), intermediate in Group A (4.2 ± 1.6), and lowest in Group C (3.0 ± 0.8; p < 0.001). Both intraperitoneal and trocar site local anesthetic administration significantly reduced postoperative pain and analgesic requirements compared with placebo. Intraperitoneal administration demonstrated superior efficacy, leading to earlier ambulation and higher patient satisfaction. Routine use of intraperitoneal local anesthetic may enhance postoperative recovery in gynecological laparoscopy.Trial registration ClinicalTrials.gov Identifier: NCT07030647 (retrospectively registered 20 June 2025).

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