Clinical trial NCT05280197: Does an Abdominal Wall Nerve Block During Surgery Help Reduce Pain From Kidney Transplantation?
Official title: Benefit of Intraoperative TAP Blocks for Kidney Transplantation- a Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Keywords: Kidney Transplant
Renal Transplant
Post-Operative Pain
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 1
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 2
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 3
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 4
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 5
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 6
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 7
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 2-1
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 2-2
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 3-1
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 3-2
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 4-1
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Twice weekly for 3 weeks, starting starting 1 week after transplant: Post-Op Week 4-2
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 2, Week 2
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 2, Week 4
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 3, Week 2
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: Every 2 weeks for 2 months, starting 1 month after the transplant date: Month 3, Week 4
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: At 6 months after the transplant date
measure: Number of morphine milligram equivalents (MME) used in the post-operative period
timeFrame: At 12 months after the transplant date
Secondary outcomes:
measure: 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.
timeFrame: 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:
measure: Incidence of post-operative nausea and vomiting
timeFrame: 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
measure: Incidence of post-operative ileus
timeFrame: 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
measure: Length of post-operative hospital stay
timeFrame: Daily from the day after transplant (Post operative day 1) until day of discharge or 30 days, whichever comes first,
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mohamed Eltemamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.