在BABA机器人辅助和内镜甲状腺切除术中，术前在皮瓣部位注射罗哌卡因和肾上腺素可安全减轻术后疼痛：一项符合CONSORT标准的双盲随机对照研究（PAIN - BREKOR试验）。
Preoperative flap-site injection with ropivacaine and epinephrine in BABA robotic and endoscopic thyroidectomy safely reduces postoperative pain: A CONSORT-compliant double-blinded randomized controlled study (PAIN-BREKOR trial).
作者信息
Lee Joon-Hyop, Suh Yong Joon, Song Ra-Yeong, Yi Jin Wook, Yu Hyeong Won, Kwon Hyungju, Choi June Young, Lee Kyu Eun
机构信息
Department of Surgery, Seoul National University Bundang Hospital, Gyeonggi-do Department of Surgery, Seoul National University Hospital and College of Medicine Cancer Research Institute, Seoul National University College of Medicine, Seoul Thyroid and Endocrine Surgery Section, Department of Surgery, Gachon University Gil Medical Center, Incheon, Republic of Korea.
出版信息
Medicine (Baltimore). 2017 Jun;96(22):e6896. doi: 10.1097/MD.0000000000006896.
BACKGROUND
Clinical trials on bilateral axillo-breast approach (BABA) thyroidectomy show that levobupivacaine and ropivacaine significantly reduce postoperative pain, but they focused on BABA robotic thyroidectomy only and did not identify specific sites of significant pain relief. Our objective was to assess the pain reduction at various sites and safety of ropivacaine-epinephrine flap injection in BABA thyroidectomy.
METHODS
This prospective double-blinded randomized controlled trial was conducted in compliance with the revised CONSORT statement (ClinicalTrials.gov registration no. NCT02112370). Patients were randomized into the ropivacaine-epinephrine arm or control (normal saline) arm.
RESULTS
From January 2014 to May 2016, 148 patients participated. The primary endpoint was site-specific pain, as measured by numeric rating scale 12 hours after surgery. The ropivacaine-epinephrine group exhibited significantly less swallowing difficulty (P = .008), anterior neck pain (P = .016), and right (P = .019) and left (P = .035) chest pain. Secondary endpoints were systolic (P = .402), diastolic (P = .827) blood pressure, and pulse rate (P = .397) after injection before incision and during surgery. The vital signs of the groups just after injection did not differ. During surgery, the ropivacaine-epinephrine patients had higher pulse rates (99 ± 13.3 vs 88 ± 16.1, P < .001) but within normal range. There were no adverse events such as postoperative nausea and vomiting. There was no significant difference in pain scores in either patient group between patients who underwent robotic or endoscopic interventions.
CONCLUSION
BABA flap-site injection with ropivacaine and epinephrine mix before incision effectively and safely reduced postoperative pain. Future studies should focus on tailoring ropivacaine and epinephrine dosage for individuals.
背景
关于双侧腋窝-乳房入路（BABA）甲状腺切除术的临床试验表明，左旋布比卡因和罗哌卡因可显著减轻术后疼痛，但这些研究仅聚焦于BABA机器人甲状腺切除术，且未明确显著减轻疼痛的具体部位。我们的目的是评估罗哌卡因-肾上腺素皮瓣注射在BABA甲状腺切除术中不同部位的疼痛减轻效果及安全性。
方法
本前瞻性双盲随机对照试验按照修订后的CONSORT声明进行（ClinicalTrials.gov注册号：NCT02112370）。患者被随机分为罗哌卡因-肾上腺素组或对照组（生理盐水组）。
结果
2014年1月至2016年5月，共有148例患者参与。主要终点是术后12小时通过数字评分量表测量的特定部位疼痛。罗哌卡因-肾上腺素组的吞咽困难（P = 0.008）、颈前疼痛（P = 0.016）以及右侧（P = 0.019）和左侧（P = 0.035）胸痛明显减轻。次要终点是注射后切开前及手术期间的收缩压（P = 0.402）、舒张压（P = 0.827）和脉搏率（P = 0.397）。注射后两组的生命体征无差异。手术期间，罗哌卡因-肾上腺素组患者的脉搏率较高（99±13.3对88±16.1，P < 0.001），但在正常范围内。未发生术后恶心、呕吐等不良事件。接受机器人或内镜干预的患者中，两组患者的疼痛评分无显著差异。
结论
术前在BABA皮瓣部位注射罗哌卡因和肾上腺素混合液可有效、安全地减轻术后疼痛。未来的研究应聚焦于为个体量身定制罗哌卡因和肾上腺素的剂量。
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