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临床试验/NCT03971708
NCT03971708已完成不适用

Investigating Systemic Effects of Lidocaine Infusion for Transversus Abdominis Plane (TAP) Block Catheter

University of Alberta1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年6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
状态
已完成
入组人数
80
试验地点
1
主要终点
Analgesic consumption

研究概览

简要总结

Lidocaine is a local anesthetic that is usually used for nerve blocks to sensory/motor blockade. However, lidocaine can also been given intravenously, and it has been shown that this method can be used to help alleviate chronic pain. We wish to investigate if lidocaine is infused via the transversus abdominis plane (TAP) block catheter will exert systemic effect, hence reduce opioid consumption and pain score in patients compared with using local anesthetic such as ropivacaine.

详细描述

Following IRB approval and written consents, patients undergoing nephrectomy were randomized into 2 groups: standard 0.2% ropivacaine infusion (control) and 0.4% lidocaine infusion for TAP catheter. The TAP catheters were placed by the surgeons under direct vision at the end of surgery before wound closure. All subjects had a general anesthetic in accordance to the discretion of the anesthesiologist in the operating room. At the end of surgery, all patients received a patient-controlled analgesia (PCA) in recovery for 48 hours. The primary outcome was the total opioid consumption at the first 27 hours post-operatively. The secondary outcomes were the total opioid consumption at 4/12/24/36/48/60 hours after the initiation of local anesthetic infusion, the numerical rating scale (NRS) at rest and on movement at 4/12/24/36/48/60 hours after the initiation of the local anesthetic infusion, the incidence of nausea and vomiting, and adverse effects.

The sample size calculation for this non-inferiority trial is based on our previous retrospective study on TAP in nephrectomy patients. A sample of 80 patients is needed, using a power of 90% with the two-sided significance level of 5%. All parametric data will be analyzed using mean and standard deviation. Non-parametric data will be analyzed using median and interquartile range. Student's t-test or Mann-Whitney U test will be used to compare between groups.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective nephrectomy
  • patients consent to study
  • ASA I to III

排除标准

  • Patient refusal
  • Allergy to lidocaine,
  • Patients with cardiac arrhythmias or on anti-arrhythmics or propranolol
  • Wolf-Parkinson White syndrome
  • Hepatic disease

研究组 & 干预措施

Ropivacaine

Other

This is the control where patients will receive ropivacaine via the TAP block infusion post-operatively.

干预措施: Ropivacaine (Drug)

Lidocaine

Active Comparator

This is the study arm where patients will receive lidocaine via the TAP block infusion post-operatively.

干预措施: Lidocaine (Drug)

结局指标

主要结局

Analgesic consumption

时间窗: first 24 hours

The amount of morphine equivalent consumption in the first 24 hours post-operatively

次要结局

  • Analgesic consumption(4, 12, 36, 48, 72 hours)
  • Pain score(4, 12, 24, 36, 48, 72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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