Intertransverse Process Block to Improve Quality of Recovery and Pain Management in Adult Cardiac Surgical Patients: a Prospective Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Quality of recovery at 24 hours after extubation
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of intertransverse process block (ITPB) in improving quality of recovery and potentially preventing chronic postsurgical pain (CPSP) in adult patients undergoing elective cardiac surgery (e.g., coronary artery bypass graft [CABG], valve repair/replacement, or combined CABG/valve procedures).
The main questions it aims to answer are:
- To investigate the quality of recovery after cardiac surgery, and its analgesic efficacy in the immediate postoperative period
- To investigate the efficacy of intertransverse process block (ITPB) on CPSP after cardiac surgery by determining the incidence of CPSP at 3 month, defined as persistent pain that was not present before surgery or that had different characteristics, and other possible causes of pain are excluded.
- To investigate the efficacy of ITPB on the incidence of CPSP at 6 month, 12 month, and the pain interference (sensory and affective components, physical activities) at 3 month, 6 month and 12 month after surgery
详细描述
Introduction:
The cornerstone of modern pain management in cardiac surgery lies in proactively preventing the development of chronic postsurgical pain (CPSP). This paradigm shift emphasizes pre-emptive interventions to disrupt the cascade of events and central sensitization that transform acute postoperative pain into a persistent, debilitating condition. CPSP, a significant and often underestimated consequence of cardiac surgery, affects a substantial proportion of patients, with prevalence rates ranging from 28% to 56% in the years following surgery. Its impact extends beyond mere discomfort, significantly impairing daily function, reducing quality of life, and imposing a substantial economic burden on the healthcare system.
The pathophysiology of CPSP involves a complex interplay of factors, with central sensitization playing a pivotal role. This process, characterized by heightened neuronal excitability within the central nervous system, amplifies pain signals and can lead to persistent pain even after the initial injury has healed. Therefore, a crucial aspect of CPSP prevention lies in disrupting the afferent nociceptive signals transmitted from the injured tissues to the spinal cord and brain, thereby preventing the establishment and perpetuation of central sensitization.
While opioids have traditionally been the mainstay of postoperative pain management, their use is not without significant drawbacks. Opioids can have dose-dependent side effects, including respiratory depression, nausea, and constipation. Furthermore, prolonged opioid use can lead to tolerance, opioid-induced hyperalgesia, and an increased risk of chronic opioid use. Recognizing these limitations, the current emphasis in pain management is on multimodal analgesia strategies that incorporate non-opioid medications and regional anaesthesia techniques to optimize pain control while minimizing the risks associated with opioid use.
Non-steroidal anti-inflammatory drugs (NSAIDs) offer a valuable adjunct in pain management, but their use in cardiac surgery is often limited due to concerns regarding bleeding complications and potential renal impairment. Other non-opioid analgesics, such as paracetamol and gabapentinoids, have shown limited efficacy in managing the intense pain associated with sternotomy. Regional anaesthesia techniques have emerged as promising strategies for both acute pain management and potential CPSP prevention in various surgical settings. Techniques such as epidural anaesthesia and paravertebral blocks have demonstrated efficacy in reducing postoperative pain intensity and opioid requirements. However, their application in cardiac surgery presents unique challenges. Epidural anaesthesia carries the risk of neuraxial hematoma due to systemic anticoagulation and heparinization, while paravertebral blocks may be associated with complications such as pneumothorax and pleural puncture. Erector spinae plane block (ESPB) has shown inconsistent results in reducing postoperative pain and morphine consumption in cardiac surgery. Parasternal plane blocks offer advantages over neuraxial techniques but may not adequately address visceral pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients aged 18 or older
- •undergoing elective CABG, valve repair/replacement, or combined CABG/valve procedure via sternotomy
排除标准
- •Emergency surgery
- •redo surgery
- •history of chronic pain or being on chronic opioids/sedatives
- •renal failure with an estimated glomerular filtration rate ≤30 ml/min (calculated by Cockcroft-Gault formula)
- •re-operation within 24 hours after surgery
- •intraoperative use of remifentanil
- •inability to provide informed consent.
研究组 & 干预措施
ITPB group
Intertransverse process block is performed on patients with injection of 20ml 0.25% levobupivacaine at the retro-SCTL space after a test bolus of 1-2ml 0.9% normal saline. The same procedure is repeated on the other side with same volume of study medication.
干预措施: Intertransverse process block (Procedure)
Sham block group
Sham intertransverse process block is performed on patients with injection of 20ml placebo at the retro-SCTL space after a test bolus of 1-2ml 0.9% normal saline. The same procedure is repeated on the other side with same volume of study medication.
干预措施: Sham block (Procedure)
结局指标
主要结局
Quality of recovery at 24 hours after extubation
时间窗: 24 hours after extubation
The score ranges from 0 to 150, with higher scores associated with better quality of recovery. Though acute pain is identified as an important predictor for the development of CPSP, advanced pain management strategies have failed to reduce the overall incidence of CPSP, suggesting a complex underlying mechanism. Evidence have demonstrated that pain-related functional interference and patient-reported outcomes, such as quality of recovery, might be associated with the development of CPSP. Thus, the primary outcome of this study is the Quality of Recovery (QoR-15) score at 24 hours after extubation. QoR is recommended for patient's comfort after surgery, and is highly valid and reliable patient-centred outcome measure.
次要结局
- Pain interference with SF-MPQ-2(3 month after surgery)
- Pain interference with SF-MPQ-2(6 month after surgery)
- Pain interference with BPI(3 month after surgery)
- Pain interference with BPI(6 month after surgery)
- Postoperative morphine consumption(2-hour, 4-hour, 8-hour, 12-hour, 24-hour, 48-hour and 72-hour after extubation)
- Time for first morphine rescue(Up to postoperative day 3, with time of first morphine required recorded)
- Intraoperative opioid consumption(Intraoperative record)
- Length of stay in ICU and hospital(Up to 1 month after surgery, length of stay in intensive care unit and hospital will be recorded)
- Number of episodes of postoperative nausea and vomiting(Perioperative up to 7 days)
- Pain interference with BPI(12 month after surgery)
- Number of episodes requested antiemetics after surgery(Up to postoperative day 7)
- Pain interference with SF-MPQ-2(12 month after surgery)
- Duration of mechanical ventilation(Up to postoperative day 1, ventilation requirement will be observed with duration of ventilation required after operation recorded.)
- Numerical rating scale(2-hour, 4-hour, 8-hour, 12-hour, 24-hour, 48-hour and 72-hour after extubation)
- Patient satisfaction with pain management(2-hour, 4-hour, 8-hour, 12-hour, 24-hour, 48-hour and 72-hour after extubation)
- Percentage and number of patients having chronic post-surgical pain(3 month, 6 month and 12 month after surgery)
研究者
WONG MAN KIN
Consultant Anaesthesiologist
Chinese University of Hong Kong
