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临床试验/NCT04073056
NCT04073056已完成4 期

Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年8月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Nima Shariat

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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Efficacy Of Quadratus Lumborum II Block For... | 临床试验