Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients

Mass General Brigham

Status and phase

Terminated

Early Phase 1

Conditions

Postoperative Pain

Burns

Treatments

Drug: Exparel

Study type

Interventional

Funder types

Other

Identifiers

NCT03705637

MGH2018P001992

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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