Elsaeed Usama A, Algyoushy Eslam Ahmed Fouad Ismail Hussein, Hatem Dina Latif Mahrous
Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Sci Rep. 2025 Sep 12;15(1):32466. doi: 10.1038/s41598-025-18389-w.
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).
腹腔镜妇科手术虽为微创手术,但术后常伴有严重疼痛,需要使用全身镇痛药。有人提议通过腹腔内或套管针穿刺部位注射局部麻醉剂来改善镇痛效果和促进恢复,但证据仍不一致。为评估和比较腹腔内及穿刺部位注射局部麻醉剂与安慰剂在减轻接受妇科腹腔镜手术女性术后疼痛及改善恢复结果方面的疗效。这项随机、双盲、三臂对照试验纳入了90名年龄在18至60岁之间、在埃及开罗艾因·库拉医院接受择期妇科腹腔镜手术的女性(2024年3月至2025年3月;ClinicalTrials.gov标识符:NCT07030647)。参与者被随机分为:A组(套管针穿刺部位注射0.25%布比卡因)、B组(腹腔内注射0.25%布比卡因)和C组(生理盐水安慰剂)。术后分别在1、6、12和24小时使用视觉模拟评分法(VAS)评估疼痛情况。次要结局包括双氯芬酸的补救使用、首次使用镇痛药的时间、双氯芬酸的总剂量、下床活动时间、住院时间和患者满意度。各组的基线人口统计学特征具有可比性。B组在1、6和12小时时疼痛评分最低(分别为0.1±0.3;2.9±1.1;2.1±0.3),其次是A组,C组最高(p<0.001)。在24小时时,疼痛评分相似(p=0.087)。与A组(83.3%)和C组(100%)相比,B组双氯芬酸的需求量显著降低(26.7%)(p<0.001)。B组首次使用补救镇痛药的时间最长(7.1±1.1小时,而A组为2.9±0.7小时,C组为1.5±0.8小时;p<0.001)。B组24小时双氯芬酸的总消耗量最低(75毫克),而A组为(114±38.2毫克),C组为(142.5±22.9毫克;p<0.001)。B组下床活动最早(3.5±0.9小时),其次是A组(5.1±0.6小时)和C组(6.9±0.8小时;p<0.001)。所有组的住院时间均为24小时。B组患者满意度最高(7.3±1.2),A组中等(4.2±1.6),C组最低(3.±0.8;p<0.001)。与安慰剂相比,腹腔内及套管针穿刺部位注射局部麻醉剂均能显著减轻术后疼痛和镇痛药需求。腹腔内注射显示出更好的疗效,能使患者更早下床活动并提高患者满意度。常规使用腹腔内局部麻醉剂可能会促进妇科腹腔镜手术后的恢复。试验注册ClinicalTrials.gov标识符:NCT07030647(2025年6月20日追溯注册)