Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients (NCT03705637) | Clinical Trial Compass
TerminatedEarly Phase 1
Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients
Stopped: Patient population too low to reasonably continue study, pandemic had started at time of cessation, further leading to study discontinuation.
United States6 participantsStarted 2019-06-01
Plain-language summary
Burn injuries are painful to patients and the sources of pain result from many areas including: the injury itself, wound care, and surgery. Inpatients that require surgical skin grafting is often required and the donor site of a skin graft is quite painful for patients. The investigators try to minimize that pain with local anesthetic as well as a combination of pain medications, the donor site pain lasts for days and is what patients often report as being the most painful part of their burn care.
There has been the development of a new form of local anesthesia that can last up to 72 hours when injected into tissue. Based on encouraging results in the literature in areas outside of burns, this study aims to evaluate whether administration of this medication at the time of surgery can help improve pain for burn patients in the postoperative period.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Burn size ≤15% TBSA
* Anticipated one trip to operating room for single stage excision and grafting
* Total donor site surface area \<500cm2
* Opioid naïve prior to admission for treatment of burn
* Patient able to consent
* 18 years or older
Exclusion Criteria:
Medical Exclusions:
* Cardiac arrhythmias
* Heart block
* Pregnancy
* Breast-feeding mothers who will be unable to stop breastfeeding for 8 days post-injection
* Allergy to bupvicaine
* Bradycardia
* Severe liver disease
* Incapacity to consent themselves
* Unlikely to survive burn Burn related exclusions
* Current substance abuse
* On opioids prior to admission
* Burn larger than 15% TBSA
* Prior autografting for this particular burn
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Morphine milligram equivalents (MME) administered after receiving Exparel