Mulcahy Michael J, Elalingam Thananchayan, Jang Kevin, D'Souza Mario, Tait Matthew
Department of Neurosurgery, Nepean Public Hospital, Sydney, Australia.
Macquarie Neurosurgery, Suite 201, 2 Technology Place, Sydney, Australia.
Trials. 2021 Jun 29;22(1):424. doi: 10.1186/s13063-021-05377-4.
There has been increasing focus to improve the quality of recovery following anterior cervical spine surgery (ACSS). Postoperative pain and nausea are the most common reasons for prolonged hospital stay and readmission after ACSS. Superficial cervical plexus block (SCPB) provides site-specific analgesia with minimal side effects, thereby improving the quality of recovery. The aim of our study was to investigate the effect bilateral cervical plexus block has on postoperative recovery in patients undergoing ACSS.
The study is a pragmatic, multi-centre, blinded, parallel-group, randomised placebo-controlled trial. 136 eligible patients (68 in each group) undergoing ACSS will be included. Patients randomised to the intervention group will have a SCPB administered under ultrasound guidance with a local anaesthetic solution (0.2% ropivacaine, 15mL); patients randomised to the placebo group will be injected in an identical manner with a saline solution. The primary outcome is the 40-item quality of recovery questionnaire score at 24 h after surgery. In addition, comparisons between groups will be made for a 24-h opioid usage and length of hospital stay. Neck pain intensity will be quantified using the numeric rating scale at 1, 3, 6 and at 24 h postoperatively. Incidence of nausea, vomiting, dysphagia or hoarseness in the first 24 h after surgery will also be measured.
By conducting a blinded placebo trial, we aim to control for the bias inherently associated with a tangible medical intervention and show the true treatment effect of SCPB in ACSS. A statistically significant result will indicate an overall improved quality of recovery for patients; alternatively, if no benefit is shown, this trial will provide evidence that this intervention is unnecessary.
ClinicalTrials.gov ACTRN12619000028101. Prospectively registered on 11 January 2019 with Australia New Zealand Clinical Trials Registry.
提高颈椎前路手术（ACSS）后恢复质量的关注度日益增加。术后疼痛和恶心是ACSS后住院时间延长和再次入院的最常见原因。颈浅丛阻滞（SCPB）提供部位特异性镇痛且副作用最小，从而提高恢复质量。我们研究的目的是调查双侧颈丛阻滞对接受ACSS患者术后恢复的影响。
本研究是一项实用的、多中心、双盲、平行组、随机安慰剂对照试验。将纳入136例接受ACSS的符合条件患者（每组68例）。随机分配至干预组的患者将在超声引导下使用局部麻醉溶液（0.2%罗哌卡因，15mL）进行SCPB；随机分配至安慰剂组的患者将以相同方式注射生理盐水。主要结局是术后24小时的40项恢复质量问卷评分。此外，将对两组之间的24小时阿片类药物使用情况和住院时间进行比较。术后1、3、6和24小时将使用数字评分量表对颈部疼痛强度进行量化。还将测量术后24小时内恶心、呕吐、吞咽困难或声音嘶哑的发生率。
通过进行双盲安慰剂试验，我们旨在控制与切实的医学干预固有相关的偏倚，并显示SCPB在ACSS中的真实治疗效果。具有统计学意义的结果将表明患者的总体恢复质量得到改善；相反，如果未显示出益处，该试验将提供证据证明这种干预是不必要的。
ClinicalTrials.gov ACTRN12619000028101。于2019年1月11日在澳大利亚新西兰临床试验注册中心进行前瞻性注册。
