Jiang Wencai, Peng Yanhua, Chen Xuemeng, Fu Lijuan, Zhai Wenhu, Zhang Xianjie, Zhou Yukai
Department of Anesthesiology, Deyang People's Hospital, Deyang, China.
Department of Anesthesiology, Deyang People's Hospital, Deyang, China
BMJ Open. 2024 Dec 12;14(12):e088177. doi: 10.1136/bmjopen-2024-088177.
Supraclavicular brachial plexus block (SCB) is a common regional analgesic technique for upper limb fracture surgery, but it often leads to rebound pain. Our primary aim is to determine whether different administration methods of esketamine can reduce rebound pain in patients undergoing SCB for upper limb fracture surgery.
METHODS/DESIGN: This study is designed as a single-centre, double-blinded, prospective, randomised controlled trial. Patients undergoing upper limb fracture surgery, who plan to use a tourniquet, aged 18-60 years, with a body mass index of 18-30 kg/m and an American Society of Anaesthesiologists classification of I-III will be randomised into three groups after providing written informed consent: group N (perineural esketamine/ropivacaine); group V (intravenous esketamine/perineural ropivacaine); and group C (perineural ropivacaine). The primary outcome will be the percentage of patients experiencing rebound pain within 24 hours postoperatively. Secondary outcomes include the Numeric Rating Scale (NRS) score of rebound pain, the onset of rebound pain, (since performing SCB), the cumulative area under the curve of NRS pain severity scores through 48 hours postsurgery, postoperative opioid consumption at 48 hours postoperatively, onset and duration of the sensory blockade, onset and duration of the motor blockade and adverse reactions and adverse events. Patients will be followed-up to 48 hours postoperatively.
This protocol describes the design of a randomised controlled trial to evaluate the effect of different modes of administration of esketamine combined with SCB on the incidence of rebound pain after upper limb fracture surgery. The results may help to identify the most effective methods for managing pain in patients undergoing upper limb fracture surgery.
This study has been approved by the Ethics Committee of the Deyang People's Hospital (2023-03-010-K01). It was registered on the Chinese Clinical Trials Registry on 24 August 2023. We intend to publish the results in a peer-reviewed journal.
ChiCTR2300075083.
锁骨上臂丛神经阻滞(SCB)是上肢骨折手术常用的区域镇痛技术,但常导致术后疼痛反弹。我们的主要目的是确定不同给药方式的艾司氯胺酮是否能减轻接受上肢骨折手术的SCB患者的疼痛反弹。
方法/设计:本研究设计为单中心、双盲、前瞻性随机对照试验。计划使用止血带、年龄在18 - 60岁、体重指数为18 - 30kg/m²且美国麻醉医师协会分级为I - III级的上肢骨折手术患者,在提供书面知情同意书后将被随机分为三组:N组(神经周围注射艾司氯胺酮/罗哌卡因);V组(静脉注射艾司氯胺酮/神经周围注射罗哌卡因);C组(神经周围注射罗哌卡因)。主要结局指标为术后24小时内出现疼痛反弹的患者百分比。次要结局指标包括疼痛反弹的数字评分量表(NRS)评分、疼痛反弹的起始时间(自实施SCB起)、术后48小时内NRS疼痛严重程度评分曲线下面积、术后48小时的阿片类药物消耗量、感觉阻滞的起始时间和持续时间、运动阻滞的起始时间和持续时间以及不良反应和不良事件。患者将被随访至术后48小时。
本方案描述了一项随机对照试验的设计,以评估艾司氯胺酮不同给药方式联合SCB对上肢骨折手术后疼痛反弹发生率的影响。研究结果可能有助于确定上肢骨折手术患者疼痛管理的最有效方法。
本研究已获得德阳市人民医院伦理委员会批准(2023 - 03 - 010 - K01)。于2023年8月24日在中国临床试验注册中心注册。我们计划在同行评审期刊上发表研究结果。
ChiCTR2300075083。