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临床试验/NCT03843879
NCT03843879Unknown2 期

A Comparison of Transversus Abdominis Plane Blocks Versus Continuous Intravenous Lidocaine for Kidney Transplant Surgery

Benaroya Research Institute1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
124
试验地点
1
主要终点
Opioid Consumption

研究概览

简要总结

This study will compare continuous intravenous lidocaine against single-injection transversus abdominis plane (TAP) block as a modality for postoperative analgesia in kidney transplant surgery.

详细描述

This study is a non-inferiority trial designed to assess the analgesic efficacy of an intravenous (IV) lidocaine infusion against single-injection transversus abdominis plane (TAP) block in patients undergoing kidney transplant surgery. The investigators propose a study of 124 subjects randomized into two groups. The control group will receive a TAP block. The study group will receive a continuous IV lidocaine infusion. The investigators hypothesize that there will be no statistically significant difference in postoperative opioid consumption between the two groups in the first 24 hours.

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
None

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

  • Kidney transplant recipient
  • >18 years old
  • Consent to participate

排除标准

  • <18 years old
  • Refusal to participate
  • Chronic opioid use
  • Seizure disorder
  • Allergy to local anesthestics
  • Severe hepatic disease

研究组 & 干预措施

TAP Block

Active Comparator

Single-injection transversus abdominis plane block

干预措施: Transversus Abdominis Plane Block (Procedure)

IV Lidocaine

Active Comparator

Continuous intravenous lidocaine infusion

干预措施: Intravenous Lidocaine (Drug)

结局指标

主要结局

Opioid Consumption

时间窗: 0-24 Hours

Total opioid utilization

次要结局

  • Pain Scores(0-48 Hours)
  • Opioid Consumption(24-48 Hours)
  • Opioid-Related Adverse Events(0-48 Hours)
  • Block/Infusion-Related Adverse Events(0-48 Hours)
  • Opioid Usage(30 days from discharge)

研究者

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

Neil Hanson

Anesthesiologist

Benaroya Research Institute

研究点 (1)

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