Comparison of Ultrasound-Guided Modified Thoracolumbar Interfascial Plane Block Versus Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative 48-Hour PCA Opioid Consumption
研究概览
简要总结
Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. Ultrasound-guided regional analgesia techniques are increasingly used to improve postoperative pain management after lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block has been shown to provide effective analgesia for lumbar instrumentation surgery, and its modified technique (mTLIP) has been reported to enhance postoperative pain control. The quadro-iliac plane (QIP) block is a newly described fascial plane block with promising results in lumbar spine surgery. This randomized controlled trial aims to compare the postoperative analgesic effectiveness of the modified thoracolumbar interfascial plane block and the quadro-iliac plane block in patients undergoing lumbar instrumentation surgery.
详细描述
Lumbar instrumentation surgery is commonly associated with moderate-to-severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction. Inadequate pain control may lead to delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay.
Ultrasound-guided regional analgesia techniques, particularly fascial plane blocks, are increasingly used as part of multimodal analgesia in lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block is an established technique that provides effective analgesia and has been modified to improve its clinical application, resulting in the modified thoracolumbar interfascial plane (mTLIP) block. Previous studies have demonstrated the effectiveness of mTLIP for postoperative analgesia after lumbar instrumentation surgery.
The quadro-iliac plane block (QIPB) is a recently described ultrasound-guided fascial plane block. Early reports suggest that QIPB may provide effective analgesia in lumbar spine procedures; however, comparative evidence with established techniques remains limited.
This prospective randomized controlled trial aims to compare bilateral ultrasound-guided mTLIP and QIPB performed at the end of surgery in patients undergoing elective lumbar instrumentation surgery under general anesthesia, to evaluate whether QIPB can be considered a safe and effective alternative to mTLIP for postoperative analgesia.
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 (Investigator, Outcomes Assessor)
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 between 18 and 65 years
- •Classified as American Society of Anesthesiologists physical status I-III
- •Scheduled for elective lumbar instrumentation surgery under general anesthesia
- •Provision of written informed consent
排除标准
- •Use of anticoagulant medications or presence of bleeding diathesis
- •Known allergy or hypersensitivity to local anesthetics or opioid drugs
- •Infection at the planned block site
- •Alcohol or drug dependence
- •Cognitive impairment preventing reliable pain assessment
- •Pregnancy or lactation
- •History of previous lumbar spine surgery
- •Diabetes mellitus
- •Renal or hepatic insufficiency
研究组 & 干预措施
Modified Thoracolumbar Interfascial Plane Block (mTLIP) Group
Participants in this group will receive a bilateral ultrasound-guided modified thoracolumbar interfascial plane block (mTLIP) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, the ultrasound probe will be placed in the parasagittal plane at the midpoint of the surgical incision, taking into account the operated lumbar levels. The paraspinal muscles will be identified, and using an in-plane technique, the needle will be advanced into the interfascial plane between the longissimus and iliocostalis muscles. After confirmation of correct needle placement with saline, 20 mL of 0.25% bupivacaine will be injected on each side. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine.
干预措施: Modified Thoracolumbar Interfascial Plane Block (mTLIP) (Procedure)
Quadro-Iliac Plane Block (QIPB) Group
Participants in this group will receive a bilateral ultrasound-guided quadro-iliac plane block (QIPB) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, a convex ultrasound probe will be placed at the point where the quadratus lumborum muscle attaches to the iliac crest. The erector spinae and quadratus lumborum muscles will be identified, and correct needle placement will be confirmed with saline injection. Subsequently, 20 mL of 0.25% bupivacaine will be injected on each side, with visualization of local anesthetic spread between the erector spinae and quadratus lumborum muscles. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine.
干预措施: Quadro-Iliac Plane Block (QIPB): (Procedure)
结局指标
主要结局
Postoperative 48-Hour PCA Opioid Consumption
时间窗: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).
次要结局
- QoR-15 Recovery Score(Postoperative 24th and 48th hours)
- Dynamic and static Numeric Rating Scale scores(0, 2, 4, 8, 16, 24, and 48 hours postoperatively)
- Total rescue analgesic dose(Postoperative 48 hours)
- Time of first request for rescue analgesia(Postoperative 48 hours)
- Length of Hospital Stay(Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded.)
- Block and Opioid-Related Adverse Effects and Complications(Postoperative 48 hours)
研究者
Merih Yıldız Eglen
principal investigator, MD
Bursa City Hospital