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Abdominal Wall Nerve Block for Postoperative Pain after Kidney Transplant

N/A

Waitlist Available

Led By Mohamed Eltemamy, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recipients of a single, living or deceased renal transplantation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial will test whether a TAP block can reduce pain and opioid use in kidney transplant recipients.

Who is the study for?

This trial is for individuals receiving a single kidney transplant from either living or deceased donors. It's not suitable for those getting two kidneys, have had previous transplants on the same side, need additional surgeries like nephrectomy, or have urine or bowel diversions.Check my eligibility

What is being tested?

The study tests if a TAP block with liposomal bupivacaine and free bupivacaine reduces pain after kidney transplant surgery compared to a placebo (saline). Participants are randomly assigned to receive either the TAP block or saline without knowing which one they get.See study design

What are the potential side effects?

Possible side effects include discomfort at the injection site, potential nerve damage, allergic reactions to bupivacaine, and less commonly systemic toxicity affecting the heart or brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received a kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Morphine

Secondary outcome measures

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.

Other outcome measures

Incidence of post-operative ileus

Incidence of post-operative nausea and vomiting

Length of post-operative hospital stay

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: liposomal bupivacaine plus free bupivacaineExperimental Treatment2 Interventions

Group II: normal salinePlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAP block

2010

Completed Phase 4

~2040

Bupivacaine

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,365,852 Total Patients Enrolled

Mohamed Eltemamy, MDPrincipal InvestigatorThe Cleveland Clinic

2 Previous Clinical Trials

99 Total Patients Enrolled

Media Library

TAP block Clinical Trial Eligibility Overview. Trial Name: NCT05280197 — N/A

Kidney Transplant Research Study Groups: liposomal bupivacaine plus free bupivacaine, normal saline

Kidney Transplant Clinical Trial 2023: TAP block Highlights & Side Effects. Trial Name: NCT05280197 — N/A

TAP block 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280197 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participants to join this clinical experiment at the moment?

"Per the information available on clinicaltrials.gov, recruitment for this medical investigation has ceased since March 4th 2022. Despite being no longer active, 85 other studies are currently searching for participants to join their trials."

Answered by AI

Recent research and studies

International Journal of SurgeryJournal

First Experience: Open Small Incision Rectus Sheath Approach Renal Transplant: A Case Series

Phillips, Stephen H., Sharon K. Hill, Lorie D. Lipscomb, and Joseph B. Africa. 2017. “First Experience: Open Small Incision Rectus Sheath Approach Renal Transplant: A Case Series”. International Journal of Surgery. Elsevier BV. doi:10.1016/j.ijsu.2017.01.076.

AnaesthesiaJournal

Postoperative Analgesia Following Renal Transplantation - Current Practice in the UK

Williams, M., and Q. J. W. Milner. 2003. “Postoperative Analgesia Following Renal Transplantation - Current Practice in the UK”. Anaesthesia. Wiley. doi:10.1046/j.1365-2044.2003.32661.x.

Saudi Journal of AnaesthesiaJournal

Evaluation of Transversus Abdominis Plane Block for Renal Transplant Recipients – A Meta-analysis and Trial Sequential Analysis of Published Studies

Makkar, JeetinderKaur, PreetMohinder Singh, Anuradha Borle, Aanjan Trisha, and Aashish Sinha. 2018. “Evaluation of Transversus Abdominis Plane Block for Renal Transplant Recipients – A Meta-analysis and Trial Sequential Analysis of Published Studies”. Saudi Journal of Anaesthesia. Medknow. doi:10.4103/sja.sja_598_17.

clinicaltrials.govStudy