Transversus Abdominis Plane (TAP) Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine: A Prospective Randomized Control Trial for Pain Control After Renal Transplant Surgery
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Difference in Total Opioid Consumption
研究概览
简要总结
This study is a comparison of the analgesic efficacy of transversus abdominis plane (TAP) blocks with ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.
详细描述
This study is a comparison of the analgesic efficacy of TAP blocks provided by ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.
In the Liposomal Bupivacaine group, TAP block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the TAP. Liposomal Bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the TAP.
For those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5 mls 1% lidocaine will be used for skin infiltration. A peripheral nerve catheter will be placed approximately 3-5 cm into the TAP space after injection of ropivacaine. A bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. An infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.
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
盲法说明
Unable to mask based on physical characteristics of liposomal bupivacaine
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ages 18 years or older
- •Renal Transplant Recipients
排除标准
- •Patients less than 18 years of age
- •Pregnant Women
- •Prisoners
- •Opioid Tolerant Patients taking more than 30 mg/day of oral morphine equivalent analgesia
- •Patients on Systemic anti coagulation
- •Patients unable to provide consent
- •Hypersensitivity to amide-type local anesthetic or any component of the drug formula
研究组 & 干预措施
Single dose liposomal bupivicaine
Liposomal bupivacaine TAP block: ultrasound guided TAP block a performed with up to 12 ml 0.25% bupivacaine and prolonged with liposomal bupivacaine 133 mg diluted to total volume of 20 ml with preservative free saline.
干预措施: Single Dose Liposomal Bupivicaine (Drug)
Ropivacaine Continuous Infusion Catheter
Ropivacaine Continuous Infusion Catheter: ultrasound guided TAP block and TAP catheter placement performed with 0.2% ropivacaine (2.5 mg/kg) and maintained with 0.2% ropivacaine infusion 8 ml/hour via catheter.
干预措施: Ropivacaine Continuous Infusion Catheter (Drug)
结局指标
主要结局
Difference in Total Opioid Consumption
时间窗: Through 4 days following renal transplant surgery
Total amount of opioid analgesic administered following renal transplant surgery converted using standard equivalency calculations to morphine equivalents mg/kg
次要结局
- Post Operative Nausea(Through 4 days following renal transplant surgery)
- Post Operative Vomiting(Through 4 days following renal transplant)
- Respiratory Depression(Through 4 days following renal transplant surgery)
- Post Operative Care Unit and Hospital Length of Stay(Up to 2 weeks following renal transplant surgery)
- Acquisition Costs Related to Analgesia(Up to 2 weeks following renal transplant surgery)
- Proportion of pain scores indicating severe pain(Through 4 days following renal transplant surgery)