Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-03-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burns Postoperative Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Exparel Arm

20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site.

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

* Donor sites will receive up to 50mg of 0.25marcaine with epinephrine injected uniformly into the wound.
* The donor site will also receive one bottle (266mg) of Exparel, diluted to be administered uniformly into the entire donor site, spaced out ever 3-4cm. The dilution will be as follows:

o 20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site.
* Injection of local anesthesia will be performed after the donor site has been harvested and is hemostatic. The goal is to provide the maximum time possible for the local anesthetic to work while under anesthesia, so it can benefit the patient and not be administered at the end of the case just prior to extubation.

Interventions

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Exparel

* Donor sites will receive up to 50mg of 0.25marcaine with epinephrine injected uniformly into the wound.
* The donor site will also receive one bottle (266mg) of Exparel, diluted to be administered uniformly into the entire donor site, spaced out ever 3-4cm. The dilution will be as follows:

o 20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site.
* Injection of local anesthesia will be performed after the donor site has been harvested and is hemostatic. The goal is to provide the maximum time possible for the local anesthetic to work while under anesthesia, so it can benefit the patient and not be administered at the end of the case just prior to extubation.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No