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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Procedure: TAP block; Procedure: TAP block; Drug: liposomal bupivacaine plus free bupivacaine; Drug: normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: normal saline	Procedure: TAP block; Transversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine; Procedure: TAP block; Transversus abdominis plane (TAP) nerve block with normal saline; Drug: normal saline; TAP block using normal saline
Experimental: liposomal bupivacaine plus free bupivacaine	Procedure: TAP block; Transversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine; Procedure: TAP block; Transversus abdominis plane (TAP) nerve block with normal saline; Drug: liposomal bupivacaine plus free bupivacaine; TAP block using liposomal bupivacaine plus free bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of morphine milligram equivalents (MME) used in the post-operative period	Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 1
Number of morphine milligram equivalents (MME) used in the post-operative period	Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 2
Number of morphine milligram equivalents (MME) used in the post-operative period	Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 3
Number of morphine milligram equivalents (MME) used in the post-operative period	Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 4
Number of morphine milligram equivalents (MME) used in the post-operative period	Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 5
Number of morphine milligram equivalents (MME) used in the post-operative period	Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 6
Number of morphine milligram equivalents (MME) used in the post-operative period	Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 7
Number of morphine milligram equivalents (MME) used in the post-operative period	Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 2-1
Number of morphine milligram equivalents (MME) used in the post-operative period	Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 2-2
Number of morphine milligram equivalents (MME) used in the post-operative period	Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 3-1
Number of morphine milligram equivalents (MME) used in the post-operative period	Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 3-2
Number of morphine milligram equivalents (MME) used in the post-operative period	Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 4-1
Number of morphine milligram equivalents (MME) used in the post-operative period	Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 4-2
Number of morphine milligram equivalents (MME) used in the post-operative period	Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 2, Week 2
Number of morphine milligram equivalents (MME) used in the post-operative period	Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 2, Week 4
Number of morphine milligram equivalents (MME) used in the post-operative period	Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 3, Week 2
Number of morphine milligram equivalents (MME) used in the post-operative period	Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 3, Week 4
Number of morphine milligram equivalents (MME) used in the post-operative period	At 6 months after the transplant date
Number of morphine milligram equivalents (MME) used in the post-operative period	At 12 months after the transplant date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The adapted brief pain inventory (BPI) uses a 10-point numeric scale, from 0-10. 0 indicates no pain and is the best outcome, 10 indicates the worst pain and is the worst outcome.	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

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of post-operative nausea and vomiting	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
Incidence of post-operative ileus	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
Length of post-operative hospital stay	Daily from the day after transplant (Post operative day 1) until day of discharge or 30 days, whichever comes first,

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Mohamed Eltemamy, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Kidney Transplant; Renal Transplant; Post-Operative Pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 21-748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No