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Local Anesthetic

TAP Blocks with Ropivacaine vs Liposomal Bupivacaine for Postoperative Pain

Phase 4

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Renal Transplant Recipients

Patients ages 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 4 days following renal transplant

Awards & highlights

Study Summary

This trial compares the pain-relieving effectiveness of two different types of injections near the abdominal muscles.

Who is the study for?

This trial is for adults who have received a kidney transplant and are experiencing postoperative pain. It's not suitable for those under 18, pregnant women, prisoners, patients with high opioid tolerance (taking more than 30 mg/day of oral morphine equivalent), on systemic anticoagulants, unable to consent, or allergic to amide-type local anesthetics.Check my eligibility

What is being tested?

The study compares two types of pain relief after kidney transplant surgery: one group receives a TAP block with ropivacaine plus ongoing infusion via catheter; the other gets a single shot TAP block with liposomal bupivacaine.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, nerve damage risks associated with TAP blocks, potential toxicity from local anesthetics like numbness and tingling sensations around the mouth or tongue, metallic taste in mouth, dizziness or ringing in ears.

Eligibility Criteria

Inclusion Criteria

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

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I have received a kidney transplant.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 4 days following renal transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 4 days following renal transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 4 days following renal transplant for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Difference in Total Opioid Consumption

Secondary outcome measures

Acquisition Costs Related to Analgesia

Post Operative Care Unit and Hospital Length of Stay

Post Operative Nausea

+3 more

Trial Design

2Treatment groups

Active Control

Group I: Ropivacaine Continuous Infusion CatheterActive Control1 Intervention

Ropivacaine Continuous Infusion Catheter: ultrasound guided TAP block and TAP catheter placement performed with 0.2% ropivacaine (2.5 mg/kg) and maintained with 0.2% ropivacaine infusion 8 ml/hour via catheter.

Group II: Single dose liposomal bupivicaineActive Control1 Intervention

Liposomal bupivacaine TAP block: ultrasound guided TAP block a performed with up to 12 ml 0.25% bupivacaine and prolonged with liposomal bupivacaine 133 mg diluted to total volume of 20 ml with preservative free saline.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,383 Total Patients Enrolled

Media Library

Ropivacaine Continuous Infusion Catheter (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03737604 — Phase 4

Postoperative Pain Research Study Groups: Ropivacaine Continuous Infusion Catheter, Single dose liposomal bupivicaine

Postoperative Pain Clinical Trial 2023: Ropivacaine Continuous Infusion Catheter Highlights & Side Effects. Trial Name: NCT03737604 — Phase 4

Ropivacaine Continuous Infusion Catheter (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03737604 — Phase 4

Frequently Asked Questions

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

What conditions can Single dose liposomal bupivicaine be employed to mitigate?

"Liposomal bupivicaine, administered in a single dose, is widely used to treat permphigus as well as acute nonspecific tenosynovitis, general anesthesia and childbirth."

Answered by AI

How many individuals are participating in this investigation?

"Indeed, the latest information on clinicaltrials.gov corroborates that this experiment is seeking participants. As of October 4th 2018, 200 subjects ought to be recruited from 1 medical site for this study which was most recently updated on July 5th 2022."

Answered by AI

To what extent has the Federal Drug Administration accepted single dose liposomal bupivicaine?

"As this is a Phase 4 trial, meaning Single dose liposomal bupivicaine has been approved and there is extensive data supporting its safety; our team at Power awarded it the highest possible score of 3."

Answered by AI

Is the team behind this research actively seeking participants?

"Affirmative. According to the information available on clinicaltrials.gov, this medical trial is currently enrolling participants and was first made visible on October 4th 2018; it was last revised on July 5th 2022. 200 patients are required at a single site for successful completion of the research project."

Answered by AI

Has there been any prior research regarding Single dose liposomal bupivicaine?

"At the time of writing, there are 168 independent studies concerning a single-dose liposomal bupivicaine with 33 trials in Phase 3. Whilst several of these clinical experiments take place in Germantown, Tennessee; an overall 222 sites have been approved to carry out research on this drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant

2018. "TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03737604.

All > Kidney Transplant