METHODS: This double-blinded, randomized controlled trial will enroll 74 AIS patients undergoing elective PSF. Participants will be assigned to the ESPB group or control group at a 1:1 ratio. Patients in the ESPB group will receive ultrasound-guided bilateral ESPB preoperatively, and patients in the control group received sham ESPB using normal saline. The primary joint endpoints are the area under the curve (AUC) of numerical rating scale (NRS) score and opioid consumption in postoperative 24 h. The secondary endpoints are numerical rating scale (NRS) score and opioid consumption at postoperative 0.5, 3, 6, 9, 12, 24, 36, and 48 h, rescue analgesia, recovery outcomes, and adverse events.
CONCLUSIONS: At present, studies investigating the effect of ESPB on pediatric patients are still needed. This study focuses on the effect of ESPB on pediatric patients undergoing PSF on postoperative pain control and intends to provide a new strategy of multimodal analgesia management for major spine surgery.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2300074505. Registered on August 8, 2023.
方法:这种双盲,随机对照试验将纳入74例接受选择性PSF的AIS患者.参与者将以1:1的比例分配到ESPB组或对照组。ESPB组患者术前接受超声引导双侧ESPB,对照组患者接受生理盐水假ESPB治疗。主要关节终点是术后24h的数字评定量表(NRS)评分和阿片类药物消耗的曲线下面积(AUC)。次要终点是术后0.5、3、6、9、12、24、36和48h的数字评定量表(NRS)评分和阿片类药物消耗,抢救镇痛,恢复结果,和不良事件。
结论:目前,仍需要研究ESPB对儿科患者的影响.本研究主要探讨ESPB对PSF患儿术后疼痛控制的影响,旨在为脊柱大手术提供一种多模式镇痛管理的新策略。
背景:中国临床试验注册ChiCTR2300074505。2023年8月8日注册。