罗哌卡因复合舒芬太尼用于电视辅助胸腔镜手术后连续胸椎旁神经阻滞镇痛效果的随机对照研究
Adding sufentanil to ropivacaine in continuous thoracic paravertebral block fails to improve analgesia after video-assisted thoracic surgery: A randomised controlled trial.
机构信息
From the Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'Anesthésie-Réanimation (CB), Hospices Civils de Lyon, Hôpital Cardiologique et Pneumologique Louis Pradel, Service d'Anesthésie-Réanimation (IP, CK, J-LF), Hospices Civils de Lyon, Service de Biostatistique - Bioinformatique (CM, PR), Faculté de Médecine, Université Claude Bernard Lyon 1 (CM, PR, J-LF), CNRS UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Département Biostatistiques et modélisation pour la santé et l'environnement, Equipe Biostatistique-Santé (CM, PR) and Hospices Civils de Lyon, Hôpital Cardiologique et Pneumologique Louis Pradel, Service de Chirurgie Thoracique, Lyon, France (J-MM).
出版信息
Eur J Anaesthesiol. 2018 Oct;35(10):766-773. doi: 10.1097/EJA.0000000000000777.
BACKGROUND
The benefit of adding opioid to a local anaesthetic for continuous thoracic paravertebral analgesia after video-assisted thoracic surgery (VATS) is unclear.
OBJECTIVES
To analyse the analgesic efficacy of ropivacaine and sufentanil in combination compared with ropivacaine alone after VATS.
DESIGN
A randomised, double-blinded, single-centre clinical trial.
SETTING
A tertiary university hospital between March 2010 and April 2014.
PATIENTS
Ninety patients were recruited, two were not included leaving 88 randomised into two groups. Eighteen patients were excluded from analysis and 70 completed the study.
INTERVENTION
To receive thoracic paravertebral analgesia with either 2 mg ml ropivacaine and 0.25 μg ml sufentanil (ropivacaine + sufentanil group) or 2 mg ml ropivacaine alone (ropivacaine group) for 48 h postoperatively. Infusion rate was set at 0.15 ml kg h in both groups.
MAIN OUTCOME MEASURES
The primary endpoint was the mean total amount of self-administered morphine by the patients in each group at 48 h postoperatively.
RESULTS
The mean ± SD total amount of self-administered morphine was not significantly different between groups (53.1 ± 27.2 mg in the ropivacaine + sufentanil group vs. 58.8 ± 34.3 mg in the ropivacaine group; P = 0.72). No significant differences were found between the two groups in either pain scores at rest or during movement, in opioid-related adverse reactions, in patient satisfaction or length of hospital stay.
CONCLUSION
Adding 0.25 μg ml sufentanil to 2 mg ml ropivacaine in continuous thoracic paravertebral analgesia for VATS did not reduce morphine consumption or pain scores when compared with ropivacaine alone. We cannot recommend its use for routine clinical practice. Further studies analysing different concentrations and infusion rates of sufentanil are needed before a lack of efficacy can be confirmed.
TRIAL REGISTRATION
Clinical trial registrations: EudraCT: 2009-014832-38. ClinicalTrials.gov: NCT 01082744.
背景
在电视辅助胸腔镜手术（VATS）后，局部麻醉剂中加入阿片类药物用于连续胸椎旁神经阻滞镇痛的益处尚不清楚。
目的
分析罗哌卡因和舒芬太尼联合应用与单用罗哌卡因相比在 VATS 后的镇痛效果。
设计
随机、双盲、单中心临床试验。
地点
2010 年 3 月至 2014 年 4 月期间的一家三级大学医院。
患者
共招募了 90 名患者，其中 2 名未纳入，88 名患者被随机分为两组。18 名患者被排除在分析之外，70 名患者完成了研究。
干预措施
术后接受 2mg/ml 罗哌卡因和 0.25μg/ml 舒芬太尼（罗哌卡因+舒芬太尼组）或 2mg/ml 罗哌卡因单独（罗哌卡因组）的胸椎旁神经阻滞镇痛，持续 48 小时。两组输注速度均设定为 0.15ml/kg/h。
主要观察指标
主要终点是两组患者在术后 48 小时内自行给予吗啡的平均总量。
结果
两组患者的平均总吗啡用量无显著差异（罗哌卡因+舒芬太尼组 53.1±27.2mg，罗哌卡因组 58.8±34.3mg；P=0.72）。两组患者在静息或运动时的疼痛评分、阿片类药物相关不良反应、患者满意度或住院时间方面均无显著差异。
结论
与单用罗哌卡因相比，在 VATS 连续胸椎旁神经阻滞镇痛中加入 0.25μg/ml 舒芬太尼并未减少吗啡用量或疼痛评分。我们不能推荐其用于常规临床实践。在确认缺乏疗效之前，需要进一步研究分析不同浓度和舒芬太尼输注率。
试验注册
临床试验注册：EudraCT：2009-014832-38。ClinicalTrials.gov：NCT 01082744。
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