Effects of Preoperative Extended-release Dinalbuphine Sebacate as an Analgesia in Ileostomy Reversal: A Randomized, Open-label Study

納疼解用於造口接合手術術後止痛：一項隨機分組開放性研究

Hung-Chang Chen(陳宏彰) ； Tao-Wei Ke(柯道維) ； Hwei-Ming Wang(王輝明) ； Sheng-Chi Chang(張伸吉) ； Ming-Hao Hsieh(謝明浩) ； Yuan-Yao Tsai(蔡元耀) ； William Tzu-Liang Chen(陳自諒)

《中華民國大腸直腸外科醫學會雜誌》 34卷1期 (2023/03) Pp. 24-33

https://doi.org/10.6312/SCRSTW.202303_34(1).11129

摘要

Purpose. Analgesia following stoma takedown is an essential postoperative management step because it is associated with recovery, complications, and patient satisfaction. Dinalbuphine sebacate (DS) is a novel long-acting analgesic. This open-label, randomized study investigated the efficacy and safety of DS as an analgesia following ileostomy reversal. Materials and Methods. Patients who had undergone laparoscopic surgery and been scheduled to receive ileostomy reversal were equally randomized into DS and control groups. In the DS group, patients were intra-gluteally injected with a single dose of 150 mg/2 mL DS 12 hours before surgery. In both groups, fentanyl was administered as required in the postoperative recovery room; in wards, opioids and ketorolac were administered for breakthrough pain whose numerical rating scale (NRS) ≥ 4 and < 4, respectively. Results. Thirty-eight patients completing all assessments were analyzed. The primary endpoint, mean fentanyl consumption, was significantly lower in the DS group (13.8 ± 27.5μg vs. 36.1 ± 38.6μg, p = 0.045). No significant difference was observed in morphine, nalbuphine, and ketorolac amounts administered in wards between the groups. The DS group also reported a reduction in pain intensity on postoperative day (POD) 0 (3.9 vs. 4.9, p = 0.010) and POD 1 (1.5 vs. 2.5, p = 0.045) compared with the control. Since POD 2, the mean pain scores were all lower than 2.0 in both groups, without significant differences. No serious adverse reactions were observed. Conclusions. Extended-release DS reduced the consumption of opioids and the pain intensity after ileostomy reversal surgery safely.

關鍵字

Dinalbuphine sebacate ； Ileostomy reversal ； Morphine ； Postoperative analgesia

並列摘要

目的：止痛是造口關閉手術術後管理的重點之一，它與患者的康復、併發症發生率和醫療滿意度密切相關。Dinalbuphine sebacate（DS）為一新型長效止痛劑。本研究為開放性、隨機分組設計，針對DS應用於迴腸造口關閉手術術後止痛的有效性和安全性進行觀察分析。材料與方法：本研究納入已接受過腹腔鏡手術並計劃進行迴腸造口關閉的患者進行研究，隨機分為DS組和對照組。DS組患者在術前12小時於臀大肌注射一劑2毫升、150 mg的DS。兩組均在術後恢復室依患者需求給予芬太尼；在病房中，對疼痛分數 ≥ 4或< 4的突發性疼痛，分別給予阿片類藥物或酮咯酸。結果：共計38名患者完成所有評估項目。主要終點－平均芬太尼消耗量，在DS組顯著降低（13.8 ± 27.5μg vs. 36.1 ± 38.6μg, p = 0.045）。在病房內的嗎啡、納布啡和酮咯酸使用量，兩組間沒有顯著差異。與對照組相比，DS組術後第0天（3.9 vs. 4.9, p = 0.010）和第一天（1.5 vs. 2.5, p = 0.045）的疼痛強度較低。自第二天起，兩組的平均疼痛評分均低於2.0，無顯著差異。本研究未觀察到嚴重不良反應。結論：長效緩釋DS安全地減少了阿片類藥物的消耗和迴腸造口關閉手術後的疼痛強度。

並列關鍵字

納疼解（Dinalbuphine sebacate） ； 迴腸造口關閉手術 ； 嗎啡 ； 術後止痛

參考文獻

Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectalcancer: incidence, mortality, survival, and risk factors. Prz Gastroenterol 2019;14(2):89-103. http://10.5114/pg.2018. 81072

Ferlay J, Colombet M, Soerjomataram I, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 cuntries and 25 major cancers in 2018. European Journal of Cancer 2018;103:356-87. http://doi.org/10.1016/j.ejca.2018.07.005

Dekker E, Tanis PJ, Vleugels JLA, et al. Colorectal cancer. Lancet 2019;394(10207):1467-80. http://10.1016/S0140- 6736(19)32319-0

Grupa VEM, Kroon HM, Ozmen I, et al. Current practice in Australia and New Zealand for defunctioning ileostomy afterrectal cancer surgery with anastomosis: analysis of the Binational Colorectal Cancer Audit. Colorectal Dis 2021;23(6):1421-33. http://10.1111/codi.15607

Mu Y, Zhao L, He H, Zhao H, et al. The efficacy of ileostomyafter laparoscopic rectal cancer surgery: a meta-analysis. World J Surg Oncol 2021;19(1):318. Published 2021 Nov 4.http://10.1186/s12957-021-02432-x