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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

Must not have

Opioid Tolerant Patients taking more than 30 mg/day of oral morphine equivalent analgesia

Patients unable to provide consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 4 days following renal transplant

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take more than 30 mg/day of pain medication similar to morphine.

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I am unable to give consent by myself.

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I am on blood thinners.

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I am under 18 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in Total Opioid Consumption

Secondary study objectives

Acquisition Costs Related to Analgesia

Post Operative Care Unit and Hospital Length of Stay

Post Operative Nausea

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 6Eligibility criteria met