An Early Phase 1 interventional study of Exparel in Burns and Postoperative Pain, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Other
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.
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.
730 studies on the registry are indexed under Burns; 146 are open to participants now.
This study's enrollment of 6 is below the median of 40 across 534 interventional studies indexed under Burns.
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Exclusion Criteria:
Medical Exclusions:
20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site.
Drug: 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.
Morphine milligram equivalents (MME) administered after receiving Exparel
Hypothesis: Subjects that receive Exparel will require fewer opioids to control their pain post-operatively (compared to historical controls).
Time frame: 3 weeks after hospital discharge
Length of hospital stay
Hypothesis: Subjects who receive Exparel will be ready or discharge sooner than historical controls due to improved pain control
Time frame: Up to 4 weeks
Plan to share: No — IPD will not be shared with other researchers outside of those directly involved in this study.
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine
Massachusetts General Hospital →