Li Shuang, Bao Ju, Qu Yuan, Zhang Bo, Cao Xinni, Huang Yanping, Liu Zhe
Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.
Department of Anesthesiology, Peking University First Hospital, Beijing 100034, China.
Matern Fetal Med. 2025 Apr;7(2):69-75. doi: 10.1097/FM9.0000000000000266. Epub 2025 Feb 10.
To compare the analgesic effects of ibuprofen administered orally via two modes combined with a conventional, patient-controlled intravenous analgesia pump on maternal pain after cesarean section (CS).
This prospective, randomized, controlled study enrolled females who underwent CS from August 2022 to August 2023 at Peking University First Hospital, Beijing, China. Participants were randomly assigned to either an as-needed ibuprofen group (300 mg orally upon request) or a scheduled ibuprofen group (300 mg every 12 hours for 48 hours). The primary outcomes assessed were postoperative pain levels using the Wong-Baker Faces Pain Scale-Revised and cumulative oxycodone consumption at multiple time points up to 48 hours post-delivery. Secondary outcomes included recovery parameters (time to first flatus, ambulation, and lactation initiation), patient satisfaction with pain control, and postpartum depression scores evaluated by the Edinburgh Postnatal Depression Scale on postoperative day 3. Normally distributed data analyzed with -tests; non-normal data with Mann-Whitney U tests; categorical variables with chi-square or Fisher's exact tests (SPSS 26.0, < 0.05).
After excluding 61 non-eligible cases, 339 patients were included (171 as-needed 168 scheduled). The scheduled group showed significantly better pain control at 12 hours (4.00 (2.00-5.50) 4.00 (4.00-6.00), < 0.001), 24 hours (4.00 (2.00-4.00) 4.00 (2.00-6.00), < 0.001), and 36 hours (2.00 (2.00-4.00) 4.00 (2.00-4.00), < 0.001), and 48 hours (2.00 (2.00-4.00) 2.00 (2.00-4.00), = 0.004) post-delivery and lower levels of oxycodone consumption at 36 hours (10.20 (8.20-13.35) 11.00 (8.80-14.40), = 0.042) and 48 hours (12.40 (10.40-15.95) 13.80 (11.00-16.00), = 0.020) postpartum compared with those in the as-needed group. Additionally, the time to the return of bowel movements was shorter in the scheduled group than in the as-needed group (23.50 (16.94, 31.47) 27.00 (19.88, 35.97), = 0.004). Differences in post-delivery ambulation, lactation initiation, satisfaction levels, and depression scores were not significantly different between the two groups.
The results of this study promote the use of ibuprofen (scheduled oral administration) combined with a conventional, patient-controlled intravenous analgesia pump for achieving better post-CS pain control than an as-needed dosage regimen.
Chinese Clinical Trial Registry, ChiCTR2400082474.
比较两种口服布洛芬给药方式联合传统的患者自控静脉镇痛泵对剖宫产术后产妇疼痛的镇痛效果。
本前瞻性、随机对照研究纳入了2022年8月至2023年8月在中国北京北京大学第一医院接受剖宫产的女性。参与者被随机分为按需布洛芬组(按需口服300mg)或定时布洛芬组(每12小时口服300mg,共48小时)。评估的主要结局指标为使用修订的面部表情疼痛量表评估的术后疼痛水平以及产后48小时内多个时间点的羟考酮累积消耗量。次要结局指标包括恢复参数(首次排气时间、下床活动时间和开始泌乳时间)、患者对疼痛控制的满意度以及术后第3天使用爱丁堡产后抑郁量表评估的产后抑郁评分。正态分布数据采用t检验分析;非正态数据采用曼-惠特尼U检验;分类变量采用卡方检验或Fisher精确检验(SPSS 26.0,P<0.05)。
排除61例不符合条件的病例后,共纳入339例患者(按需组171例,定时组168例)。定时组在产后12小时(4.00(2.00 - 5.50)比4.00(4.00 - 6.00),P<0.001)、24小时(4.00(2.00 - 4.00)比4.00(2.00 - 6.00),P<0.001)、36小时(2.00(2.00 - 4.00)比4.00(2.00 - 4.00),P<0.001)和48小时(2.00(2.00 - 4.00)比2.00(2.00 - 4.00),P = 0.004)的疼痛控制明显更好,且在产后36小时(10.20(8.20 - 13.35)比11.00(8.80 - 14.40),P = 0.042)和48小时(12.40(10.40 - 15.95)比13.80(11.00 - 16.00),P = 0.020)的羟考酮消耗量更低。此外,定时组的首次排便时间比按需组短(23.50(16.94,31.47)比27.00(19.88,35.97),P = 0.004)。两组在产后下床活动、开始泌乳、满意度水平和抑郁评分方面的差异无统计学意义。
本研究结果支持使用布洛芬(定时口服给药)联合传统的患者自控静脉镇痛泵,以实现比按需给药方案更好的剖宫产术后疼痛控制。
中国临床试验注册中心,ChiCTR2400082474