Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, China.
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Trials. 2020 May 5;21(1):381. doi: 10.1186/s13063-020-04308-z.
Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space-occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. Intense immediate postoperative pain after many spinal procedures makes its control of utmost importance. Preemptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement; however, the analgesic effect is only maintained for a relatively short period of time. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomy has better short-term and long-term effects than the local anesthetic alone has not been reported yet.
The PRE-EASE trial is a prospective, randomized, open-label, blinded endpoint, single-center clinical study including 116 participants scheduled for elective laminoplasty or laminectomy, with a 6 months' follow-up process. Preemptive local infiltration with betamethasone and ropivacaine (treatment group) or ropivacaine alone (control group) throughout the entire thickness of the planned incision site will be performed by the surgeon prior to making the incision. The primary outcome will be the cumulative butorphanol consumption within the first 48-h postoperative period.
This study will add significant new knowledge to the effect and feasibility of preemptive local infiltration of betamethasone for postoperative pain management in laminoplasty and laminectomy.
ClinicalTrials.gov: NCT04153396. Registered on 6 November 2019.
椎管内占位病变、椎管狭窄、椎间盘突出、损伤等疾病的治疗已沿用数十年，采用的术式包括椎板成形术和椎板切除术。术后，患者手术部位常出现剧烈疼痛。许多脊柱手术后会立即出现剧烈的术后疼痛，因此控制疼痛至关重要。局部麻醉药的预防性注射可显著减轻休息和运动时的术后疼痛，但镇痛效果仅能维持较短的时间。与单独使用局部麻醉药相比，在椎板成形术或椎板切除术时使用倍他米松联合局部麻醉药是否具有更好的短期和长期效果尚未见报道。
PRE-EASE 试验是一项前瞻性、随机、开放标签、盲终点、单中心临床试验，纳入 116 例择期行椎板成形术或椎板切除术的患者，随访时间为 6 个月。术者在切开前，在计划切口的整个厚度进行倍他米松和罗哌卡因（治疗组）或罗哌卡因（对照组）的预防性局部浸润。主要结局是术后 48 小时内累积布托啡诺消耗量。
本研究将为椎板成形术和椎板切除术的术后疼痛管理中预防性局部浸润倍他米松的效果和可行性提供重要的新知识。
ClinicalTrials.gov：NCT04153396。于 2019 年 11 月 6 日注册。
