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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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
462 Previous Clinical Trials
169,132 Total Patients Enrolled
4 Trials studying Burns
144 Patients Enrolled for Burns
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:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What primary ailments can Group 1 be applied to?
"Group 1 treatments are frequently used to treat minor burns, but they can also provide relief from lupus erythematosus cell, ulcerative colitis and transplantation."
Answered by AI
What security measures can be taken to ensure Group 1 is not a hazard for people?
"As this is a phase 4 trial, which signals a treatment's approval, our team at Power gave Group 1 an assessment of 3 on the safety scale."
Answered by AI
How many volunteers are currently partaking in this clinical experiment?
"Indeed. According to clinicaltrials.gov, this study posted on March 18th 2019 is still enrolling patients and was recently updated on December 28th 2022. 75 participants are needed at the single site hosting the trial."
Answered by AI
Are there still open slots available for this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that this investigation, which was published on March 18th 2019, is currently seeking participants. An estimated 75 people need to be enrolled from 1 center of care."
Answered by AI
What further research has been conducted concerning Group 1?
"At present, 40 trials for Group 1 are in the third phase of development. Furthermore, 192 active studies exist within this group and 1203 locations across Germantown, Tennessee have been conducting these tests."
Answered by AI
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