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Completed

NCT Number: NCT05280197

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

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.

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Key information

Conditions

Kidney Transplantation Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP Block

Procedure

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

liposomal bupivacaine plus free bupivacaine

Drug

TAP block using liposomal bupivacaine plus free bupivacaine

normal saline

Drug

TAP block using normal saline

Primary outcomes

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

    Time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 1

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

    Time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 2

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

    Time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 3

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

    Time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 4

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

    Time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 5

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

    Time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 6

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

    Time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 7

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

    Time frame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 2-1

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

    Time frame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 2-2

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

    Time frame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 3-1

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

    Time frame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 3-2

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

    Time frame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 4-1

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

    Time frame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 4-2

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

    Time frame: Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 2, Week 2

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

    Time frame: Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 2, Week 4

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

    Time frame: Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 3, Week 2

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

    Time frame: Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 3, Week 4

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

    Time frame: At 6 months after the transplant date

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

    Time frame: 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.

    Time frame: 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

    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.

Other outcomes

  1. Incidence of post-operative nausea and vomiting

    Time frame: 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

  2. Incidence of post-operative ileus

    Time frame: 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

  3. Length of post-operative hospital stay

    Time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 30 days, whichever comes first,

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2022
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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