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临床试验/NCT03490357
NCT03490357已完成不适用

Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison in Regional Anesthesia Techniques With an Enhanced Recovery After Surgery Pathway

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2018年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
2
主要终点
Dermatomal Mapping

研究概览

简要总结

The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.

详细描述

The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.

  • Compare QL and TAP blocks cephalad spread via mapping in the Postoperative Acute Care Unit (PACU) within 6 hours after block placement.
  • Compare efficacy of blocks via Visual Analogue Scale (VAS) pain scores in PACU and postoperative day (POD) 1.
  • Compare amount of opioid pain medications consumed within 24 hours after block. Hypothesis
  • The QL block will prove superior to the TAP block in both cephalad spread and pain control for abdominal surgery patients and decrease the amount of opioid pain medications required while in effect up to 24 hours after surgery.
  • The quadratus lumborum will have increased cephalad spread. We predict mapping will show greater (2 or more dermatomal levels) or equal analgesic coverage by the QL block when compared to the TAP block.

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

Outcome assessor and patient blinded to type of block that the patient receives. Outcome assessor will check dermatomal levels after surgery.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients scheduled for laparoscopic abdominal surgery as posted by the surgeon
  • Part of the ERAS protocol as listed by the surgeon
  • Age 18 years and older
  • Elective procedure

排除标准

  • • Patient inability to consent
  • Patient inability to communicate for data collection
  • Conversion from laparoscopic to open case
  • Local anesthetic allergy
  • Weight less than 50 kg
  • Anatomical variation making block visualization unlikely
  • Inability to cooperate with block
  • Surgery posted longer than 6 hours
  • Known preoperative substance abuse
  • Chronic opioid use > 3 months
  • Patient exhibits dependence on opioids Daily opioid use for pain control

结局指标

主要结局

Dermatomal Mapping

时间窗: 6 hours

The primary outcome of interest is the proportion of subjects reporting a positive block. This is determined by dermatomal mapping in cephalad direction in PACU within 6 hours of TAP or QL placement. A positive outcome is one where the QL block measures 2 or more dermatomal levels higher than the TAP block

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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