Does an Abdominal Wall Nerve Block During Surgery Help Reduce Pain From Kidney Transplantation?

NCT ID: NCT05280197

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-08
• Study Completion Date: 2023-11-08

Brief Summary

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.

Detailed Description

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.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

liposomal bupivacaine plus free bupivacaine

Group Type: EXPERIMENTAL

TAP block

Intervention Type: PROCEDURE

Transversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine

liposomal bupivacaine plus free bupivacaine

Intervention Type: DRUG

TAP block using liposomal bupivacaine plus free bupivacaine

normal saline

Group Type: PLACEBO_COMPARATOR

TAP block

Intervention Type: PROCEDURE

Transversus abdominis plane (TAP) nerve block with normal saline

normal saline

Intervention Type: DRUG

TAP block using normal saline

Interventions

TAP block

Transversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine

Intervention Type: PROCEDURE

TAP block

Transversus abdominis plane (TAP) nerve block with normal saline

Intervention Type: PROCEDURE

liposomal bupivacaine plus free bupivacaine

TAP block using liposomal bupivacaine plus free bupivacaine

Intervention Type: DRUG

normal saline

TAP block using normal saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Recipients of a single, living or deceased renal transplantation

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Eltemamy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Eltemamy, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Williams M, Milner QJ. Postoperative analgesia following renal transplantation - current practice in the UK. Anaesthesia. 2003 Jul;58(7):712-3. doi: 10.1046/j.1365-2044.2003.32661.x. No abstract available.

Reference Type: BACKGROUND

PMID: 12790818 (View on PubMed)

Singh PM, Borle A, Makkar JK, Trisha A, Sinha A. Evaluation of transversus abdominis plane block for renal transplant recipients - A meta-analysis and trial sequential analysis of published studies. Saudi J Anaesth. 2018 Apr-Jun;12(2):261-271. doi: 10.4103/sja.SJA_598_17.

Reference Type: BACKGROUND

PMID: 29628838 (View on PubMed)

Phillips SH, Hill SK, Lipscomb LD, Africa JB. First experience: Open small incision rectus sheath approach renal transplant: A case series. Int J Surg. 2017 Mar;39:114-118. doi: 10.1016/j.ijsu.2017.01.076. Epub 2017 Jan 18.

Reference Type: BACKGROUND

PMID: 28110032 (View on PubMed)

Other Identifiers

21-748

Identifier Type: -

Identifier Source: org_study_id