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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Procedure: TAP block
* Procedure: TAP block
* Drug: liposomal bupivacaine plus free bupivacaine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplant, Renal Transplant, Post-Operative Pain