Investigating Systemic Effects of Lidocaine Infusion for Transversus Abdominis Plane (TAP) Block Catheter
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
- 是
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
This is the control where patients will receive ropivacaine via the TAP block infusion post-operatively.
干预措施: Ropivacaine (Drug)
Lidocaine
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)
