Ultrasound Guided Erector Spinae Plane (ESP) Catheter Versus Video-assisted Paravertebral Catheter Placement in Minimally Invasive Thoracic Surgery (MITS): Comparing Continuous Infusion Analgesic Techniques on Early Quality of Recovery, Respiratory Function, and Chronic Persistent Surgical Pain: A Multicentre, Randomised, Double-blind, Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Quality of Recovery (QoR-15) score between Anaesthesiologist-administered ultrasound guided Erector Spinae block and Surgeon-administered video-assisted Paravertebral block at 24 hours postoperative.
研究概览
简要总结
Minimally Invasive Thoracic Surgery (MITS) is a surgical method used to perform lung surgery through small incisions between the ribs and includes both Video-Assisted Thoracic Surgery (VATS) and Robotic assisted Thoracic Surgery (RATS). MITS can cause a significant amount of postoperative pain and if this is not adequately controlled, it can delay the patient's recovery and it may be a precipitating factor for the development of Chronic Persistent Surgical Pain (CPSP).
Regional anaesthesia is the use of nerve numbing medications known as local anaesthetics to block sensations of pain from a specific area of the body. For MITS, blocking pain arising from the chest wall/rib cage would improve the patient's recovery after the operation and overall patient satisfaction.
There have been significant advancements made in thoracic (chest wall) regional anaesthesia techniques. Ultimately, this involves injecting local anaesthetics around the nerves that supply the chest wall. A single injection of these medications will only have a maximum effect for up to 12 hours and often this is considerably less. To prolong the pain free benefit, a thin tube known as a catheter will be placed so that the local anaesthesia medication can be continuously given by a specific mechanical pump designed for this purpose. This mechanical pump will be located at the patient's bedside and can precisely deliver the medication in question at a rate between 10-15 ml/hr. This infusion of local anaesthesia medication will continue for 48 hours after the operation and will be monitored by the hospital's pain team.
The primary aim of this study is to compare the efficacy of two techniques for thoracic regional anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either an Anaesthesiologist ultrasound guided Erector Spinae Plane Block (ESP) with catheter insertion or surgeon video-assisted Paravertebral block (PVB) with catheter insertion. Both these regional anaesthesia techniques are well established in clinical practice, but there is little evidence published comparing them for this type of surgery, in terms of quality of patient's short term (1-2 days) and longer-term (3 months) recovery.
详细描述
Erector Spinae Plane (ESP) block has emerged as a new regional anaesthesia technique which has had promising early results in attenuating severe acute pain associated with Minimal Invasive Thoracic Surgery (MITS). In a recent randomised control trial among MITS patients, single-shot ESP block improved Quality of Recovery score (QoR-15) and reduced overall complications at 24 hr compared with single-shot serratus anterior plane block (SAP).
Paravertebral block (PVB) has been widely used for analgesia after thoracic surgery for over two decades because it reduces postoperative pain and opioid requirements. When compared with systemic analgesia and alongside with epidural analgesia, it is considered the "gold standard" for thoracic regional analgesia techniques. Both ESP and PVB have usually been described as a single-shot technique. However, catheter techniques offer the prospect of flexibility and prolonged analgesia.
Placement of a thoracic PVB catheter can be achieved by an anatomical landmark or ultrasound technique. Ultrasound technique has a higher success rate and safer profile when compared to the landmark technique but is technically challenging. However, in MITS an opportunity arises for directly visualised placement of a PVB catheter by the surgeon under thoracoscopic guidance. Insertion of the PVB catheter and verification by the surgeon under direct vision could be a more reliable and safer method, but there are limited randomised controlled trials examining the efficacy of this technique. Also, there are limited clinical effectiveness trials on the catheter-based ESP analgesia technique using patient-centred outcomes. Furthermore, no study has evaluated the effect of acute analgesia over 24-48 hr with continuous regional nerve block on CPSP at 3 months after MITS.
Therefore, the investigators aim to complete a multicentre, prospective, double-blinded, randomised controlled clinical trial to test the hypothesis that Anaesthesiologist-administered, ultrasound guided ESP catheter analgesia is equivalent to surgeon-administered, video-assisted PVB catheter analgesia, in terms of early recovery (QoR-15), respiratory spirometric function at 24-48 hr, and CPSP at 3 months after MITS surgery.
Study setting: This study will take place between three level four academic hospitals in the Republic of Ireland (Mater Misericordiae Univeristy Hospital-MMUH, St Vincent's University Hospital-SVUH and St Jame's University Hospital-SJH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The erector spinae plane and paravertebral blocks with catheter insertion will be performed after induction of general anaesthesia and therefore participants will be blinded to which intervention they have had.
The outcome assessors for this study will be unaware as to which group the participant will be randomised to and therefore they will be blinded to which intervention the participant had received.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants providing written informed consent
- •American Society of Anesthesiologist grade 1-4
- •Unilateral MITS (VATS and RATS) under general anaesthesia
排除标准
- •Absence of written consent
- •Unexpected conversion of MITS to open thoracotomy
- •Contraindications to peripheral regional anaesthesia block: (Infection at local site, allergy to local anaesthesia medications, patient refusal, previous or existing neurological deficit, anticoagulated patients)
- •Known dementia at time of MITS and inability to give informed consent
- •Unexpected post-operative admission to ICU for continued ventilation
- •History of opioid abuse
结局指标
主要结局
Quality of Recovery (QoR-15) score between Anaesthesiologist-administered ultrasound guided Erector Spinae block and Surgeon-administered video-assisted Paravertebral block at 24 hours postoperative.
时间窗: 24 hours postoperative
QoR-15 is a 15-parameter questionnaire which has been recommended as an optimum tool to evaluate overall patient recovery after surgery and this includes postoperative pain. Participants will complete this questionnaire at 24 hours after their surgery. It is scored between 0 and 150, where 150 indicates that the patient has had an excellent recovery.
次要结局
- Time of administration of first intravenous opioid(48 hours postoperative)
- Total 48 hours morphine consumption(48 hours postoperative)
- Pulmonary Function Assessment(Preoperatively (day 0), postoperative day 1 and postoperative day 2)
- Area Under the Curve (AUC) of Verbal Rating Score (VRS) for pain at rest and on deep inspiration versus time over 48 hours(48 hours postoperative)
- Length of hospital stay(1 month)
- Comprehensive Complication Index Calculator (CCI)(1 month)
- Documentation of adverse events(48 hours postoperative)
- Quality of Recovery (QoR-15) score between Anaesthesiologist-administered ultrasound guided Erector Spinae block and Surgeon-administered video-assisted Paravertebral block at 48 hours postoperative.(48 hours postoperative)
- Chronic Persistent Surgical Pain (CPSP) after Minimally Invasive Thoracic Surgery (MITS)(3 months postoperative)
研究者
Aneurin Moorthy
Research Fellow in Anaesthesia and Perioperative Medicine
Mater Misericordiae University Hospital