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Liposomal Bupivacaine vs Lidocaine for Skin Graft Pain
Phase 4
Recruiting
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pain scores associated with skin graft donor site will be assessed using visual analog scale (0-10) at 4,8, 12, 24, 48 and 72 hours after surgery. they will be compared between two groups.
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trialcompares how well different anesthetics reduce pain and opioid use after skin grafts for partial or full thickness burns.
Who is the study for?
This trial is for English or Spanish speakers with less than 20% total body surface area (TBSA) burned and less than 5% deep partial/full thickness burns. It's not for those with chronic pain conditions, more extensive burns, pregnancy, or allergies to local anesthetics like lidocaine.
What is being tested?
The study compares the effectiveness of Lidocaine, Liposomal Bupivacaine, and regional nerve block in managing post-operative pain at skin graft donor sites in burn patients. It also looks at how these treatments affect opioid use after surgery.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as redness or swelling, numbness beyond the target area, low blood pressure if absorbed into circulation in large amounts, and rare allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pain scores associated with skin graft donor site will be assessed using visual analog scale (0-10) at 4,8, 12, 24, 48 and 72 hours after surgery. they will be compared between two groups.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pain scores associated with skin graft donor site will be assessed using visual analog scale (0-10) at 4,8, 12, 24, 48 and 72 hours after surgery. they will be compared between two groups.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
A measurement of post operative pain involving skin graft donor site using visual analog scale (VAS) ranging 0-10, at 8 hours post-operatively
Secondary study objectives
Opioid pain medication consumption up to 72 hours post-operatively will be compared between the subjects who are given liposomal bupivacaine (Exparel) and lidocaine at the donor sites
Pain Scores over 72 hours after surgery
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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
3Treatment groups
Experimental Treatment
Active Control
Group I: Group 3Experimental Treatment1 Intervention
Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location
Group II: Group 1Experimental Treatment1 Intervention
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Group III: Group 2Active Control1 Intervention
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine Hydrochloride
2020
Completed Phase 4
~1420
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,808 Total Patients Enrolled
3 Trials studying Infections
301 Patients Enrolled for Infections
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Burns on the front of the thighs.You have less than 20% of your body surface area burned, with less than 5% of that being deep burns.You have a long-lasting pain condition.You have burns covering more than 20% of your total body surface area, or more than 5% of your body has deep burns.You are allergic to lidocaine or other numbing medicines.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 3
- Group 3: Group 2
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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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