Kidney Transplantation
Conditions
Keywords
Kidney Transplant, Renal Transplant, Post-Operative Pain
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.
Interventions
PROCEDURETAP block
Transversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine
DRUGliposomal bupivacaine plus free bupivacaine
TAP block using liposomal bupivacaine plus free bupivacaine
DRUGnormal saline
TAP block using normal saline
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The surgeon performing the TAP block will be unblinded. The participant, investigators, and outcomes assessor will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| 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, |
Countries
United States
Outcome results
None listed