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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liposomal bupivacaine plus free bupivacaine | Experimental |
| |
| normal saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP block | Procedure | Transversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine |
|
| 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 | |
| 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 |
| Measure | Description | 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 |
Inclusion Criteria:
- Recipients of a single, living or deceased renal transplantation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Eltemamy, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12790818 | Background | 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. | |
| 29628838 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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The surgeon performing the TAP block will be unblinded. The participant, investigators, and outcomes assessor will be blinded.
| TAP block | Procedure | Transversus abdominis plane (TAP) nerve block with normal saline |
|
| liposomal bupivacaine plus free bupivacaine | Drug | TAP block using liposomal bupivacaine plus free bupivacaine |
|
| normal saline | Drug | TAP block using normal saline |
|
| 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 |
| 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, |
| 28110032 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |