Chang Tsung-Kun, Huang Ching-Wen, Su Wei-Chih, Tsai Hsiang-Lin, Ma Cheng-Jen, Yeh Yung-Sung, Chen Yen-Cheng, Li Ching-Chun, Cheng Kuang-I, Su Miao-Pei, Wang Jaw-Yuan
Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
Pain Ther. 2020 Dec;9(2):671-681. doi: 10.1007/s40122-020-00197-x. Epub 2020 Sep 29.
Post-operative pain control remains unsatisfactory in patients after laparotomy. This study aimed to evaluate the efficacy, safety, and quality of life with a single dose of extended-release dinalbuphine sebacate (ERDS) pre-operatively to intravenous patient-controlled analgesia (PCA) with fentanyl in patients undergoing laparotomy.
This was a prospective, open-label, randomized controlled study. Of 110 randomized patients, 107 completed all assessments. The area under the curve (AUC) of visual analogue scale (VAS) from baseline to 48 h after surgery, VAS throughout 7 days after surgery, post-operative analgesics use, quality of life, satisfaction, and safety were evaluated.
The AUC of VAS from baseline to 48 h after surgery were 118.6 [97.5% confidence interval (CI) 95.6-141.6] in ERDS group and 176.13 (97.5% CI 150.8-201.4) in PCA group, which showed the non-inferiority because the upper limit of the 97.5% CIs of ERDS group was lower than the lower limit of PCA group (P < 0.001), but also had superiority in favor of ERDS group (P < 0.001). ERDS group reported a significant reduction in VAS pain intensity at 4, 24, 32, 72, 120, and 144 h after surgery, and better quality of life (P < 0.05). The safety profile was comparable between ERDS and PCA groups.
In patients undergoing laparotomy, a single dose of dinalbuphine sebacate was superior to intravenous PCA with fentanyl on lower pain intensity and better quality of life.
NCT03296488.
剖腹手术后患者的术后疼痛控制仍不尽人意。本研究旨在评估术前单次注射长效丁丙诺啡癸酸酯（ERDS）联合芬太尼静脉自控镇痛（PCA）在剖腹手术患者中的疗效、安全性和生活质量。
这是一项前瞻性、开放标签、随机对照研究。110名随机分组的患者中，107名完成了所有评估。评估了从基线到术后48小时的视觉模拟量表（VAS）曲线下面积（AUC）、术后7天的VAS、术后镇痛药使用情况、生活质量、满意度和安全性。
ERDS组从基线到术后48小时的VAS AUC为118.6 [97.5%置信区间（CI）95.6 - 141.6]，PCA组为176.13（97.5% CI 150.8 - 201.4），显示出非劣效性，因为ERDS组97.5% CI的上限低于PCA组的下限（P < 0.001），且ERDS组具有优势（P < 0.001）。ERDS组术后4、24、32、72、120和144小时的VAS疼痛强度显著降低，生活质量更好（P < 0.05）。ERDS组和PCA组的安全性相当。
在接受剖腹手术的患者中，单次注射丁丙诺啡癸酸酯在降低疼痛强度和改善生活质量方面优于芬太尼静脉PCA。
NCT03296488。
