Efficacy of Thoraco-Lumbar Interfascial Plane (TLIP) Block for Postoperative Analgesia of Lumbar Spinal Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Morphine consumption in the first 24 hours post-surgery
研究概览
简要总结
Spinal surgery is associated with severe pain in the immediate postoperative period. In a recent study evaluating pain intensity on the first day after surgery in a large range of surgical procedures, among the six most painful surgeries, three were major spinal procedures. Spinal surgery causes an accumulation of several types of pain. Incisional pain results from activation of peripheral nociceptors. Musculoskeletal pain arises from damage to structures, such as bone, ligaments, muscles, intervertebral disks, and zygapophyseal joints. In addition, neuropathic pain arises from compression and damage to nerve roots exiting the spinal canal and sometimes damage to the spinal cord itself.
Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA) in order to reduce opioid consumption after surgery. Among regional anesthesia (RA) techniques, the thoraco-lumbar interfascial plane block (TLIP) was considered. It offers an effective and safe analgesia during the first 24h after herniated lumbar disc surgery. Ultrasound-guided TLIP block involves injection of LAs between longissimus and multifidus muscles (spinal lombar muscles). This injection allows to block the dorsal rami of spinal nerves innervating the paravertebral muscles and the vertebrae.
The objective of this study is to evaluate the interest of TLIP block to improve the postoperative analgesia in patients undergoing lumbar spinal fusion surgery.
详细描述
This is a multicenter, randomized, double-blind (participant and care provider assessing outcomes), parallel-group controlled, trial assessing the interest of the association of TLIP block to general anesthesia for postoperative analgesia management in patients undergoing posterior lumbar spinal fusion.
This study compares two groups:
"Control" group: standard general anesthesia. "TLIP" group: standard general anesthesia + TLIP block with an injection of 40 ml of ropivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.
• General anesthesia
General anesthesia will be standardized in the two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
To minimize assessment bias, patients and evaluators (nurse and physiotherapist) will be unaware of the intervention group. Only the investigator, who will include the patient and will realize the procedure, will know the arm of randomization.
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
- •≥ 18 years old,
- •Undergoing posterior lumbar spinal one-level or two-level fusion surgery (L3-L4, L4-L5 and/or L5-S1),
- •Having signed a written informed consent form,
- •Affiliation to the social security system.
排除标准
- •Contraindication for regional anesthesia (allergy to local anesthetics, neuropathic disease, infection at the puncture site, coagulation disorder, refusal of the technique,...)
- •Contraindication to nonsteroidal anti-inflammatory drugs,
- •Patient who have already had a spinal surgery,
- •Patient with chronic pain syndrome (use > 3 months of morphine, opioid analgesics of class 3, pregabalin or gabapentin) or fibromyalgia,
- •A mental or linguistic inability to understand the study,
- •Patient under protection of the adults (guardianship, curators or safeguard of justice),
- •Pregnant or or breastfeeding women.
结局指标
主要结局
Morphine consumption in the first 24 hours post-surgery
时间窗: 24 hours
Total amount of morphine (mg) administered during the first 24 hours post-surgery. The reference time t0 will be the time of skin incision.
次要结局
- Postoperative pain: Visual Analogue Scale (VAS)(48 hours)
- Postoperative quality of recovery(72 hours)
- Morphine consumption in the first 48 hours post-surgery(48 hours)
- Duration of postoperative analgesia(48 hours)
- Side effects associated with opioids(72 hours)
- Morphine consumption in the post-anesthesia care unit (PACU)(6 hours)
- Rate of complications(20 minutes, 72 hours)