Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients

NCT03705637 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: MGH2018P001992
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  3 weeks after hospital discharge

Secondary Outcomes (1)

• Length of hospital stay

  Up to 4 weeks

Study Arms (1)

Exparel Arm

EXPERIMENTAL

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

Drug: Exparel

Interventions

Exparel 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.

Exparel Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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
• Current substance abuse
• On opioids prior to admission
• Burn larger than 15% TBSA
• Prior autografting for this particular burn

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.

  PMID: 25912739 BACKGROUND

• Mehran RJ, Martin LW, Baker CM, Mena GE, Rice DC. Pain Management in an Enhanced Recovery Pathway After Thoracic Surgical Procedures. Ann Thorac Surg. 2016 Dec;102(6):e595-e596. doi: 10.1016/j.athoracsur.2016.05.050.

  PMID: 27847094 BACKGROUND

• Dissanaike S, McCauley J, Alphonso C. Liposomal bupivacaine for the management of postsurgical donor site pain in patients with burn injuries: a case series from two institutions. Clin Case Rep. 2017 Dec 5;6(1):129-135. doi: 10.1002/ccr3.1292. eCollection 2018 Jan.

  PMID: 29375852 BACKGROUND

• Kaplan RS, Porter ME. How to solve the cost crisis in health care. Harv Bus Rev. 2011 Sep;89(9):46-52, 54, 56-61 passim.

  PMID: 21939127 BACKGROUND

MeSH Terms

Conditions

Burns; Pain, Postoperative

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of surgery, Harvard Medical School

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 15, 2018
• Study Start: June 1, 2019
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)