Kidney TransplantationNCT05280197
Does an Abdominal Wall Nerve Block During Surgery Help Reduce Pain From Kidney Transplantation?
A study testing TAP block, liposomal bupivacaine plus free bupivacaine and normal saline in people with Kidney Transplantation, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- TAP block, liposomal bupivacaine plus free bupivacaine and normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2022to 8 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of a single, living or deceased renal transplantation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit of Intraoperative TAP Blocks for Kidney Transplantation- a Randomized, Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Kidney Transplantation
- Being tested
- TAP block, liposomal bupivacaine plus free bupivacaine, normal saline
- Keywords
- Kidney Transplant, Renal Transplant, Post-Operative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
Transversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine
TAP blockProcedure or surgery
Transversus abdominis plane (TAP) nerve block with normal saline
liposomal bupivacaine plus free bupivacaineDrug
TAP block using liposomal bupivacaine plus free bupivacaine
normal salineDrug
TAP block using normal saline
| Study group | Role | What they receive |
|---|---|---|
| liposomal bupivacaine plus free bupivacaine | Experimental | Not described Receives: Procedure: TAP block; Drug: liposomal bupivacaine plus free bupivacaine |
| normal saline | Placebo comparator | Not described Receives: Procedure: TAP block; Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of morphine milligram equivalents (MME) used in the post-operative period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 6 months after the transplant date
Number of morphine milligram equivalents (MME) used in the post-operative period
Measured: At 12 months after the transplant date
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start8 Jan 2022
- Primary completion24 Mar 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Eltemamy, The Cleveland Clinic
- Investigators
- Mohamed Eltemamy, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280197
- Sponsor's protocol ID
- 21-748
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2022
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12790818Singh 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.
PubMed 29628838Phillips 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.
PubMed 28110032
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Intraoperative TAP Blocks for Kidney Transplantation- a Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05280197
- Acronym / sponsor ID
- 21-748
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplant, Renal Transplant, Post-Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liposomal bupivacaine plus free bupivacaine | Experimental | Procedure: TAP block, Drug: liposomal bupivacaine plus free bupivacaine |
| normal saline | Placebo comparator | Procedure: TAP block, Drug: normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recipients of a single, living or deceased renal transplantation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP blockTransversus abdominis plane (TAP) nerve block with liposomal bupivacaine plus free bupivacaine | Procedure or surgery | liposomal bupivacaine plus free bupivacaine |
| TAP blockTransversus abdominis plane (TAP) nerve block with normal saline | Procedure or surgery | normal saline |
| liposomal bupivacaine plus free bupivacaineTAP block using liposomal bupivacaine plus free bupivacaine | Drug | liposomal bupivacaine plus free bupivacaine |
| normal salineTAP block using normal saline | Drug | normal saline |
Primary outcome
Number of morphine milligram equivalents (MME) used in the post-operative period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 6 months after the transplant date
Number of morphine milligram equivalents (MME) used in the post-operative period
Time frame: At 12 months after the transplant date
1 secondary outcome
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.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Background: PubMed 12790818Williams 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.
- Background: PubMed 29628838Singh 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.
- Background: PubMed 28110032Phillips 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Eltemamy, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block, liposomal bupivacaine plus free bupivacaine and normal saline in people with Kidney Transplantation, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of morphine milligram equivalents (MME) used in the post-operative period (time frame: Daily from the day after transplant (Post operative day 1) until day of discharge or 7 days, whichever comes first: Post-op Day 1). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280197, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025; AzTrials last refreshed its copy on 28 Oct 2026.