Transversus Abdominis Plane Catheter Following Kidney Transplantation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 主要终点
- Oral morphine equivalent (OME)
研究概览
简要总结
Continuous Infusion of Local Anesthetic After Kidney Transplantation
This is a phase III, randomized, double-blinded, sham-controlled trial comparing the use of a continuous infusion of local anesthetic via transversus abdominis plane (TAP) catheter to a saline infusion (sham) via TAP catheter along with standard postoperative analgesia in patients undergoing kidney transplantation. Patients will have a TAP catheter placed at the time of kidney transplantation by the surgical team under direct vision. They are then randomized to a continuous infusion of local anesthetic or saline for 48 hours postoperatively. Both groups will receive a standard postoperative analgesic regimen including a Patient Controlled Analgesic (PCA) pump and multimodal analgesics including acetaminophen and gabapentin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male, female, non-binary gender, aged >18 years.
- •Undergoing a kidney transplant (deceased or living donor) as treatment for stage 5 chronic kidney disease (Glomerular filtration rate < 15ml/min) either on dialysis, or approaching dialysis
- •No history of allergy to any local anesthetic.
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
排除标准
- •Current use of opioid pain medications prior to kidney transplantation.
- •Known allergic reactions to components of any local anesthetic medication.
- •Prior local anesthetic systemic toxicity.
- •History of chronic pain undergoing current active treatment for the same.
- •Age <18 years (this analgesic approach has not been established in this population).
- •Unable or unwilling to use IV PCA pump for any reason (manual dexterity, cognitive impairment, patient choice etc.).
- •Multi-visceral transplantation.
- •Incision other than standard Gibson incision.
- •Unilateral or bilateral nephrectomy at time of kidney transplant.
- •Advanced liver disease.
研究组 & 干预措施
Local Anaesthetic Infusion
干预措施: Ropivacaine (Drug)
Saline Infusion
干预措施: Saline (Drug)
结局指标
主要结局
Oral morphine equivalent (OME)
时间窗: 48 hours post kidney transplantation
OME in mg
次要结局
- Visual Analog Scale pain rating(12, 24, and 48 hours post kidney transplantation)
- Patient quality of life score(48 hours post kidney transplantation)
- Time to return of bowel function postoperatively(Duration of admission)
- Incidence of local anesthetic systemic toxicity(Duration of admission)
- Postoperative adverse events (surgical)(Duration of admission)
- Delayed graft function(Duration of admission)
- Length of stay(Duration of admission)
- Creatinine (mmol/L) at time of discharge(Duration of admission)
研究者
Andrew Rasmussen
Kidney and Pancreas Transplantation Fellow
Western University, Canada