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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
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 belowSelect...
I have received a kidney transplant.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I take more than 30 mg/day of pain medication similar to morphine.
Select...
I am unable to give consent by myself.
Select...
I am on blood thinners.
Select...
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
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,720,818 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I take more than 30 mg/day of pain medication similar to morphine.You are allergic to a specific type of local anesthetic or any of the ingredients in the drug formula.I have received a kidney transplant.I am 18 years old or older.I am unable to give consent by myself.I am on blood thinners.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Ropivacaine Continuous Infusion Catheter
- Group 2: Single dose liposomal bupivicaine
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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