NCT05280197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

January 11, 2022

Last Update Submit

June 14, 2025

Conditions

Kidney Transplantation

Keywords

Kidney TransplantRenal TransplantPost-Operative Pain

Outcome Measures

Primary Outcomes (19)

  • 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 Outcomes (1)

  • 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

Other Outcomes (3)

  • 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,

Study Arms (2)

liposomal bupivacaine plus free bupivacaine

EXPERIMENTAL
Procedure: TAP blockDrug: liposomal bupivacaine plus free bupivacaine

normal saline

PLACEBO COMPARATOR
Procedure: TAP blockDrug: normal saline

Interventions

TAP blockPROCEDURE

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

liposomal bupivacaine plus free bupivacaine
liposomal bupivacaine plus free bupivacaineDRUG

TAP block using liposomal bupivacaine plus free bupivacaine

liposomal bupivacaine plus free bupivacaine
normal salineDRUG

TAP block using normal saline

normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Recipients of a single, living or deceased renal transplantation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

  • 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.

    PMID: 12790818BACKGROUND

  • 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.

    PMID: 29628838BACKGROUND

  • 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.

    PMID: 28110032BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mohamed Eltemamy, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The surgeon performing the TAP block will be unblinded. The participant, investigators, and outcomes assessor will be blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2022

First Posted

March 15, 2022

Study Start

January 8, 2022

Primary Completion

March 24, 2023

Study Completion

November 8, 2023

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)