Division of Anaesthesiology & Perioperative Medicine, Mater University Hospital, Dublin, Ireland.
Department of Anaesthesia and Critical Care, St James's University Hospital, Dublin, Ireland.
Trials. 2021 Dec 28;22(1):965. doi: 10.1186/s13063-021-05863-9.
Compared to conventional thoracotomy, minimally invasive thoracic surgery (MITS) can reduce postoperative pain, reduce tissue trauma and contribute to better recovery. However, it still causes significant acute postoperative pain. Truncal regional anaesthesia techniques such as paravertebral and erector spinae blocks have shown to contribute to postoperative analgesia after MITS. Satisfactory placement of an ultrasound-guided thoracic paravertebral catheter can be technically challenging compared to an ultrasound-guided erector spinae catheter. However, in MITS, an opportunity arises for directly visualised placement of a paravertebral catheter by the surgeon under thoracoscopic guidance. Alongside with thoracic epidural, a paravertebral block is considered the "gold standard" of thoracic regional analgesic techniques. To the best of our knowledge, there are no randomised controlled trials comparing surgeon-administered paravertebral catheter and anaesthesiologist-assisted erector spinae catheter for MITS in terms of patient-centred outcomes such as quality of recovery.
This trial will be a prospective, double-blinded randomised controlled trial. A total of 80 eligible patients will be randomly assigned to receive either an anaesthesiologist-assisted ultrasound-guided erector spinae catheter or a surgeon-assisted video-assisted paravertebral catheter, in a 1:1 ratio following induction of general anaesthesia for minimally assisted thoracic surgery. Both groups will receive the same standardised analgesia protocol for both intra- and postoperative periods. The primary outcome is defined as Quality of Recovery (QoR-15) score between the two groups at 24 h postoperative. Secondary outcomes include assessment of chronic persistent surgical pain (CPSP) at 3 months postoperative using the Brief Pain Inventory (BPI) Short Form and Short Form McGill (SF-15) questionnaires, assessment of postoperative pulmonary function, area under the curve for Verbal Rating Score for pain at rest and on deep inspiration versus time over 48 h, total opioid consumption over 48 h, QoR-15 at 48 h, and postoperative complications and morbidity as measured by the Comprehensive Complication Index.
Despite surgical advancements in thoracic surgery, severe acute postoperative pain following MITS is still prevailing. This study will provide recommendations about the efficacy of an anaesthesia-administered ultrasound-guided erector spinae catheter or surgeon-administered, video-assisted paravertebral catheter techniques for early quality of recovery following MITS.
ClinicalTrials.gov NCT04729712 . Registered on 28 January 2021. All items from the World Health Organization Trial Registration Data Set have been included.
与传统开胸手术相比,微创胸腔手术(MITS)可减轻术后疼痛、减少组织创伤,有助于更好地康复。然而,它仍会导致明显的急性术后疼痛。与竖脊肌阻滞相比,胸段椎旁阻滞等躯干区域阻滞技术已被证明可有助于 MITS 后的术后镇痛。与超声引导下竖脊肌导管相比,超声引导下胸椎旁导管的置管技术具有挑战性。然而,在 MITS 中,外科医生可以在胸腔镜引导下直接可视化地放置胸段椎旁导管。除胸椎硬膜外阻滞外,椎旁阻滞被认为是胸部分区镇痛技术的“金标准”。据我们所知,尚无随机对照试验比较外科医生管理的椎旁导管和麻醉师辅助的竖脊肌导管在患者为中心的结局(如恢复质量)方面用于 MITS。
本试验将是一项前瞻性、双盲随机对照试验。总共 80 名符合条件的患者将在全身麻醉下接受微创辅助胸腔手术后,按照 1:1 的比例随机分配接受麻醉师辅助的超声引导下竖脊肌导管或外科医生辅助的视频辅助下椎旁导管。两组均将在围手术期内接受相同的标准化镇痛方案。主要结局定义为两组患者术后 24 小时的恢复质量(QoR-15)评分。次要结局包括术后 3 个月时使用简明疼痛量表(BPI)短表和简短 McGill 疼痛问卷(SF-15)评估慢性持续性手术疼痛(CPSP),评估术后肺功能,48 小时内静息和深呼吸时疼痛的视觉模拟评分曲线下面积与时间的关系,48 小时内阿片类药物总消耗量,48 小时时的 QoR-15,以及通过综合并发症指数测量的术后并发症和发病率。
尽管胸腔外科手术有了技术进步,但 MITS 后的严重急性术后疼痛仍然普遍存在。本研究将为麻醉师管理的超声引导下竖脊肌导管或外科医生管理的视频辅助下椎旁导管技术在 MITS 后早期恢复质量方面提供建议。
ClinicalTrials.gov NCT04729712。于 2021 年 1 月 28 日注册。已包含世界卫生组织试验注册数据集中的所有项目。