跳至主要内容
临床试验/NCT03927326
NCT03927326Unknown不适用

On Postoperative Analgesic Requirements in Laparoscopic Colorectal Surgery Patients After Exparel Administration Via Transversus Abdominis Plane Block Versus Surgical Infiltration

University of Washington0 个研究点目标入组 150 人开始时间: 2019年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
150
主要终点
24 hour post operative opioid consumption

研究概览

简要总结

This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.

详细描述

Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks.

A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.

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
Single (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

入选标准

  • Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay

排除标准

  • Patients on chronic pain mediations equaling or exceeding > 25 morphine daily equivalents
  • Patients allergic to bupivacaine
  • Patients with ASA status IV, V, or VI
  • Patients unable to consent
  • Patients that are pregnant
  • Patients that are incarcerated
  • Patients receiving procedures in addition to laparoscopic colorectal procedure
  • Patients on systemic anticoagulation precluding them from regional blocks

研究组 & 干预措施

Local infiltration

Experimental

Liposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites.

干预措施: Exparel 266 MG Per 20 ML Injection (Drug)

Transversus abdominis plane block

Experimental

Liposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block.

干预措施: Exparel 266 MG Per 20 ML Injection (Drug)

结局指标

主要结局

24 hour post operative opioid consumption

时间窗: 24 hours postoperative

Listed in morphine daily equivalents.

次要结局

  • Pain intensity at 12 hours post operative(12 hours)
  • 48 hour post operative opioid consumption(48 hours postoperative)
  • 12 hour post operative opioid consumption(12 hours postoperative)
  • Pain intensity at 24 hours post operative(24 hours)
  • Hospital length of stay(Until end of hospital stay, typically 3 days)

研究者

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

Alan Chang

Resident, School of Medicine: Anesthesiology and Pain Medicine

University of Washington

相似试验