Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients
- Registration Number
- NCT03705637
- Lead Sponsor
- Massachusetts General Hospital
- Brief 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.
- Detailed Description
Patients suffer from pain resulting from the injury, wound care, and surgical treatment of their burns. As a result, they often require considerable amounts of narcotics. Given the concern for opiate addiction and the national opiate crisis the investigators have tried to explore other non-opiate means of pain control. One of the newest methods for pain relief is with liposomal bupivacaine, which can provide local analgesia for up to 72 hours at the site of injection. This medication has been used with good effect in multiple contexts.
Skin graft donor sites are the most painful portion of their surgical treatment and the pain typically is most severe during the first few days after surgery. For this reason, the investigators believe the addition of Exparel to the donor site will help with improved multi-modal pain control, making patients more comfortable. It also may decrease opiate requirements which would be beneficial for burn patients.
Few previous studies have been conducted using Exparel at the donor sites of skin grafted burn patients. One case series compares usage of Exparel from two different institutions, however the sample size at each was relatively small (n=20, 5, respectively). Their findings suggest that Exparel may be an effective way of managing postsurgical donor site pain. Based on these limited data there is a need for more robust studies, which is the motivation for doing this larger evaluation of patients.
The investigators believe that the use of Exparel can decrease pain for patients after surgery, in particular at their skin graft donor sites. The investigators want to conduct this study to evaluate whether Exparel can improve pain control for their patients and decrease their need for opiate narcotics.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exparel Arm Exparel 20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site.
- Primary Outcome Measures
Name Time Method Morphine milligram equivalents (MME) administered after receiving Exparel 3 weeks after hospital discharge Hypothesis: Subjects that receive Exparel will require fewer opioids to control their pain post-operatively (compared to historical controls).
- Secondary Outcome Measures
Name Time Method Length of hospital stay Up to 4 weeks Hypothesis: Subjects who receive Exparel will be ready or discharge sooner than historical controls due to improved pain control
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States