Analgesic Outcomes of Ultrasound Guided Quadratus Lumborum Block Compared With Transversus Abdominis Plane Block in Patients Undergoing Midline Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity at 12 hours
研究概览
简要总结
This randomized controlled trial compares the analgesic efficacy of ultrasound-guided bilateral lateral quadratus lumborum block (QLB, QL1) versus ultrasound-guided bilateral transversus abdominis plane (TAP) block in adults undergoing elective midline laparotomy under general anesthesia. The primary focus is postoperative pain intensity, time to first rescue analgesia, proportion requiring rescue analgesia, and total opioid consumption in the first 24 hours.
详细描述
Midline laparotomy is associated with significant postoperative pain that can limit mobilization, impair respiratory function, and increase opioid-related side effects. Abdominal wall blocks such as the transversus abdominis plane (TAP) block and quadratus lumborum block (QLB) are used as part of multimodal analgesia. TAP primarily targets somatic afferents of the anterior abdominal wall, while QLB may provide broader coverage including potential paravertebral spread via the thoracolumbar fascia, potentially offering longer-lasting analgesia.
This single-center, prospective, randomized controlled trial will enroll 100 adults (50 per group) aged 18-65 years, ASA physical status I-III, scheduled for elective midline laparotomy under general anesthesia. Participants will be randomized 1:1 using sequentially numbered, opaque, sealed envelopes prepared by an independent research assistant. Both blocks will be performed after induction of general anesthesia and before surgical incision by an experienced anesthesiologist under ultrasound guidance and strict aseptic precautions.
Group A (QLB): Bilateral lateral quadratus lumborum (QL1) block with 20 mL of 0.25% bupivacaine per side (total 40 mL / 100 mg, not exceeding 2 mg/kg).
Group B (TAP): Bilateral TAP block with 20 mL of 0.25% bupivacaine per side (total 40 mL / 100 mg, not exceeding 2 mg/kg).
Postoperative analgesia will be standardized with intravenous paracetamol 1 g every 6 hours. Pain will be assessed using the Numerical Rating Scale (NRS 0-10) at 6, 12, and 24 hours by an independent, blinded outcome assessor. Rescue analgesia (intravenous morphine or tramadol) will be given for NRS ≥4. Primary and secondary analgesic outcomes include NRS scores, time to first rescue analgesia, proportion requiring rescue analgesia within 24 hours, and total opioid consumption in the first 24 hours. Block-related complications will also be recorded.
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
Patients will remain blinded to group allocation because both blocks are performed after induction of general anesthesia. The anesthesiologist administering the block cannot be blinded. Postoperative pain assessment and outcome recording will be performed by an independent outcome assessor who remains blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Either sex
- •Scheduled for elective midline laparotomy (upper, lower, or full midline incision) under general anesthesia
- •ASA physical status I-III
排除标准
- •Body mass index >40 kg/m²
- •Existing chronic pain disorder, established opioid dependence, or history of substance abuse
- •Previous or current neurological or psychiatric illness likely to compromise comprehension, decision-making capacity, or reliable reporting of pain scores
- •Conditions in which an abdominal wall block would not be appropriate or safe (bleeding tendency, ongoing anticoagulation outside acceptable limits, local skin or soft-tissue infection at the planned puncture site, or major distortion of abdominal wall anatomy)
- •Urgent laparotomy performed for peritonitis or unstable physiology (including patients requiring continuous vasopressor support)
- •Previous abdominal wall surgery, large incisional hernia, or distorted flank/anterior abdominal wall anatomy likely to impair standardized block placement
研究组 & 干预措施
Group A: Quadratus Lumborum Block (QLB)
Participants receive bilateral ultrasound-guided lateral quadratus lumborum (QL1) block after induction of general anesthesia and before surgical incision. 20 mL of 0.25% bupivacaine is injected on each side (total 40 mL / 100 mg, dose not exceeding 2 mg/kg).
干预措施: Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1) (Procedure)
Group B: Transversus Abdominis Plane Block (TAPB)
Participants receive bilateral ultrasound-guided transversus abdominis plane block after induction of general anesthesia and before surgical incision. 20 mL of 0.25% bupivacaine is injected on each side (total 40 mL / 100 mg, dose not exceeding 2 mg/kg).
干预措施: Ultrasound-Guided Transversus Abdominis Plane Block (Procedure)
Group A: Quadratus Lumborum Block (QLB)
Participants receive bilateral ultrasound-guided lateral quadratus lumborum (QL1) block after induction of general anesthesia and before surgical incision. 20 mL of 0.25% bupivacaine is injected on each side (total 40 mL / 100 mg, dose not exceeding 2 mg/kg).
干预措施: Bupivacaine 0.25% (Drug)
Group B: Transversus Abdominis Plane Block (TAPB)
Participants receive bilateral ultrasound-guided transversus abdominis plane block after induction of general anesthesia and before surgical incision. 20 mL of 0.25% bupivacaine is injected on each side (total 40 mL / 100 mg, dose not exceeding 2 mg/kg).
干预措施: Bupivacaine 0.25% (Drug)
结局指标
主要结局
Postoperative pain intensity at 12 hours
时间窗: 12 hours after completion of surgery
Pain intensity measured using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) assessed by an independent blinded outcome assessor.
次要结局
- Postoperative pain intensity at 6 hours(6 hours after completion of surgery)
- Postoperative pain intensity at 24 hours(24 hours after completion of surgery)
- Time to first rescue analgesia(From completion of surgery up to 24 hours postoperatively)
- Proportion of participants requiring rescue analgesia within 24 hours(First 24 hours after surgery)
- Total opioid/rescue analgesic consumption within 24 hours(First 24 hours after surgery)
- Incidence of block-related complications(During block performance and within 24 hours after the block)
研究者
Kiran Azhar
Post-graduate Resident (FCPS-II Anesthesia)
Sheikh Zayed Medical College