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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280197
• Other study ID #: 21-748
• Status: Completed
• Phase: N/A
• Start date: January 8, 2022
• Est. completion date: November 8, 2023

Study information

• Verified date: February 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 8, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Procedure:
• TAP block
Transversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine
• TAP block
Transversus abdominis plane (TAP) nerve block with normal saline

Drug:
• liposomal bupivacaine plus free bupivacaine
TAP block using liposomal bupivacaine plus free bupivacaine
• normal saline
TAP block using normal saline

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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,
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of morphine milligram equivalents (MME) used in the post-operative period		At 6 months after the transplant date
Primary	Number of morphine milligram equivalents (MME) used in the post-operative period		At 12 months after the transplant date
Secondary	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