跳至主要内容
临床试验/NCT05280197
NCT05280197已完成不适用

Benefit of Intraoperative TAP Blocks for Kidney Transplantation- a Randomized, Placebo Controlled Trial

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2022年1月8日最近更新:
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
224
试验地点
1
主要终点
Number of morphine milligram equivalents (MME) used in the post-operative period

研究概览

简要总结

This is a randomized, placebo controlled, double blind study to determine the effectiveness of a Transversus Abdominis Plane (TAP) block for reducing postoperative pain and opioid use in kidney transplant recipients.

详细描述

The management of post-operative analgesia in kidney transplant recipients is complex secondary to labile fluid shifts and limitations in the use of NSAIDs secondary to their potential nephrotoxicity. A majority of transplant centers rely on the use of intravenous patient-controlled opioid analgesia as the predominant method of post-operative pain control, however this practice is at odds with the worldwide initiatives to reduce post-operative opioid use and dependence.

This study is a single center prospective randomized double blinded study which will compare the post-operative benefits of TAP block with liposomal bupivacaine plus free bupivacaine versus placebo (normal saline) TAP block in participants receiving both the ARS and the Gibson incisions for kidney transplantation . Approximately 200 participants will be enrolled at the Cleveland Clinic.

The operative approach (i.e. Gibson or ARS) is at the discretion of the operating surgeon and will proceed in the standard fashion. At the completion of the dissection of the external iliac vessels and prior to bringing the transplant kidney into the field, an intraoperative TAP block will be performed by inserting a 22 gauge spinal needle from inside the abdomen into the transversus abdominus plane of the abdominal wall at the lateral superior and inferior border of the surgical dissection and injecting the pre-determined analgesic or placebo.

The remainder of the procedure, including the vascular and urinary anastomosis, will proceed identically between the two groups. All participants will receive the same post-operative abdominal surgical dressing.

Post-operative pain control will follow standard clinical guidelines. All participants will be prescribed on-demand oral Oxycodone 5 or 10 mg tablets plus IV Morphine or IV Dilaudid if needed for severe breakthrough pain. On discharge, all participants will receive ten 5 or 10 mg Oxycodone tablets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The surgeon performing the TAP block will be unblinded. The participant, investigators, and outcomes assessor will be blinded.

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

  • Recipients of a single, living or deceased renal transplantation

排除标准

  • Previous renal transplantation on the same side of the body
  • Requiring a native or graft nephrectomy or other additional procedures
  • Urine diversion or augmentation
  • Bowel diversion
  • Recipients of an enbloc pediatric kidney
  • Recipients of a dual kidney transplantation

研究组 & 干预措施

normal saline

Placebo Comparator

干预措施: TAP block (Procedure)

liposomal bupivacaine plus free bupivacaine

Experimental

干预措施: TAP block (Procedure)

liposomal bupivacaine plus free bupivacaine

Experimental

干预措施: liposomal bupivacaine plus free bupivacaine (Drug)

normal saline

Placebo Comparator

干预措施: normal saline (Drug)

结局指标

主要结局

Number of morphine milligram equivalents (MME) used in the post-operative period

时间窗: At 12 months after the transplant date

次要结局

  • Level of postoperative pain using using an adapted version of the brief pain inventory (BPI) which uses a 10-point numeric scale from 0-10.(Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first, then weekly for 3 weeks, then every 2 weeks for 2 months, then at 6 months and 12 month post surgical date)

研究者

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

Mohamed Eltemamy

Principal Investigator

The Cleveland Clinic

研究点 (1)

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