Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- The Amount of Opioid Consumption During and After Procedure
研究概览
简要总结
The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery.
详细描述
The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. Like the more commonly used transversus abdominis plane (TAP) block, the QL 2 block targets the anterior rami of T7-T12, ilioinguinal, iliohypogastric, and the lateral cutaneous branches of L1-L3. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery. Conventional therapy has consisted of surgical infiltration of the incision ports with bupivacaine 0.25%. The study team proposes a study to compare the analgesic effects of the QL 2 block with conventional therapy, consisting of surgical wound infiltration, for postoperative analgesia following laparoscopic gastric sleeve gastrectomy.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy
- •18-65 years of age
- •BMI> 35 kg/m2.
排除标准
- •Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
- •Contraindication/allergy to acetaminophen or ketorolac
- •History of substance abuse or chronic opioid use
- •Coagulopathy
- •Patients receiving systemic anticoagulation
- •Local infection
研究组 & 干预措施
Conventional Therapy
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
干预措施: Bupivacaine (Drug)
Quadratus Lumborum II Group
The QL 2 group will receive 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
The Amount of Opioid Consumption During and After Procedure
时间窗: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine)
次要结局
- Heart Rate(1 hour after surgery)
- Respiratory Rate(1 hour post op)
- Time to First Dose of Analgesic Request(up to 60 minutes)
- Blood Pressure(1 hour after surgery)
- PACU Length of Stay(average 2 hours)
- Number of Participants With Pain(Up to 48 hours)
- VAS Pain Scores(Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2)
- Number of Participants With Nausea(the first 48 hours after the procedure)
研究者
Ali Nima Shariat
Assistant Professor
Icahn School of Medicine at Mount Sinai
