Safety and Efficacy of Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block on Quality of Recovery in Laparoscopic Upper Abdominal Surgeries: A Randomized Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- The postoperative Quality of Recovery-15 score
研究概览
简要总结
This study aims to compare and evaluate the safety and efficacy of ultrasound guided retrolaminar block versus transverse abdominis plane block in laparoscopic upper abdominal surgeries. Both RLB and TAP blockade are hypothesized to reduce analgesic consumption, manage pain effectively and minimize side effects but their comparative effectiveness has not yet to be thoroughly explored.
详细描述
Laparoscopic surgery is now a widely accepted practice, offering several advantages, including better cosmetic outcomes, increased patient satisfaction, and shorter hospital stays . The complexity and range of procedures performed laparoscopically have grown significantly, now including complex operations like cholecystectomy, nephrectomy, hernia repair, and an increasing number of emergency surgeries .
Despite these benefits, postoperative pain following laparoscopic procedures, such as cholecystectomy, can be substantial and hinder recovery . This pain may negatively affect respiratory function, delay ambulation, and ultimately prolong their hospital stay. Historically, pain management has often relied on high doses of narcotics, which may lead to complications like dizziness, respiratory depression, and postoperative nausea and vomiting (PONV) . These drawbacks have spurred the search for alternative and improved pain relief strategies .
Ultrasound-guided nerve blocks have become an essential component of multimodal postoperative analgesia due to their effectiveness, precision, and safety profile . One of such techniques is the Transversus Abdominis Plane (TAP) block, which is used as part of a comprehensive strategy to optimize postoperative pain control. Local anesthetic is injected into the neurovascular plane of the abdominal wall . The TAP block works by providing sensory blockade to the spinal nerves that run between the internal oblique and transverse abdominis muscles. The anesthetic infiltration affects the thoracic intercostal nerves, the ilioinguinal and iliohypogastric nerves, and the lateral cutaneous branches of the lumbar nerves.
Another important technique is the Retrolaminar Block (RLB), introduced in 2006 as a simpler alternative to the thoracic paravertebral block (TPVB) . The RLB is less invasive because it targets the bony vertebral lamina, unlike the TPVB, which requires puncturing the superior costotransverse ligament . The procedure involves injecting a local anesthetic (LA) into the fascial plane located between the posterior thoracic lamina and the overlying transversus spinae muscles allowing spread of the local anesthetic to the thoracic paravertebral and epidural spaces, thus the blockade of the dorsal branch of the spinal nerves that cross the retrolaminar plane .Studies, including cadaveric models, have confirmed that the anesthetic injected during an RLB spreads through the intertransverse ligaments into the paravertebral and epidural spaces, effectively numbing 2-4 spinal segments . For instance, a 2022 clinical trial showed that ultrasound-guided RLBs significantly reduced opioid consumption in patients recovering from laparoscopic cholecystectomy compared to conventional pain management , highlighting its potential as a safe and effective option.
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)
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21 and 65 years.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Body mass index (BMI) less than 30 kg/m².
- •Scheduled for elective laparoscopic upper abdominal surgery under general anesthesia.
排除标准
- •Refusal to participate in the study.
- •Known allergy or hypersensitivity to any of the study drugs.
- •Infection at the planned block insertion site.
- •Severe uncontrolled cardiac, renal, hepatic, neurological, or respiratory disease.
- •Pre-existing chronic pain.
- •Immunodeficiency.
- •Coagulation abnormalities, anticoagulant therapy, or platelet count less than 80,000/µL.
- •Emergency surgery.
研究组 & 干预措施
Retrolaminar Block Group
Patients will receive an ultrasound-guided retrolaminar block using 20 ml of 0.25% of bupivacaine administered at the T7 level at both sides
干预措施: Ultrasound-guided Retrolaminar Block group (Procedure)
Transverses Abdominis Plane (TAP) Block Group
Patients will receive an ultrasound-guided TAP block using 20 ml of 0.25% bupivacaine at both sids
干预措施: Transverses Abdominis Plane (TAP) Block Group (Procedure)
结局指标
主要结局
The postoperative Quality of Recovery-15 score
时间窗: 24 hour postoperative
The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 items. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
次要结局
- Numeric Rating Scale (NRS) at rest and during coughing(Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.)
- Total dose of rescue analgesics administered (mg) within the first 24 hours after surgery(From the end of surgery to 24 hours after surgery.)
- Time to first postoperative opioid analgesic request (hours)(From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively)
- Duration of hospital stay(From the date of surgery until hospital discharge, assessed for up to 30 days after surgery)
- Mean intraoperative mean arterial pressure (mmHg)(At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.)
- Mean intraoperative heart rate (beats/min)(At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.)
- Mean intraoperative peripheral oxygen saturation (%)(At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.)
- Number of participants with postoperative nausea(From the end of surgery to 24 hours after surgery)
- Number of participants with postoperative vomiting(From the end of surgery to 24 hours after surgery)
- Number of participants with postoperative shivering(From the end of surgery to 24 hours after surgery)
- Number of participants with postoperative hypotension(From the end of surgery to 24 hours after surgery)
- Number of participants with postoperative bradycardia(From the end of surgery to 24 hours after surgery)
- Number of participants with postoperative headache(From the end of surgery to 24 hours after surgery)
- Total intraoperative ephedrine dose administered (mg)(From induction of anesthesia until the end of surgery)
- Number of participants requiring intraoperative ephedrine administration(From induction of anesthesia until the end of surgery)
