Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain

NCT03854344 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 143321
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine, Liposomal Bupivicaine or regional nerve block for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds.

Conditions

Pain, Postoperative; Burns

Outcome Measures

Primary Outcomes (1)

• A Measurement of Post Operative Pain Involving Skin Graft Donor Site Using Visual Analog Scale (VAS) Ranging 0-10, at 8 Hours Post-operatively

  Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine

  The subject completes a pain assessment at 8 hours post-operatively.

Secondary Outcomes (2)

• Opioid Pain Medication Consumption up to 72 Hours Post-operatively Will be Compared Between the Subjects Who Are Given Liposomal Bupivacaine (Exparel) and Lidocaine at the Donor Sites

  72 hours (3 days) post operatively

• Pain Scores Over 72 Hours After Surgery

  Pain scores associated with skin graft donor site will be assessed using Visual Analog Scale (0-10) at 72 hours after surgery. They will be compared between the groups.

Study Arms (3)

Group 1

EXPERIMENTAL

Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting

Drug: Liposomal bupivacaine

Group 2

ACTIVE COMPARATOR

Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting

Drug: Lidocaine Hydrochloride

Group 3

EXPERIMENTAL

Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location

Drug: Bupivacaine Hydrochloride

Interventions

Liposomal bupivacaine DRUG

Injected subcutaneously for skin graft harvesting

Also known as: Exparel

Group 1

Bupivacaine Hydrochloride DRUG

Used for regional nerve block for skin graft harvesting

Group 3

Lidocaine Hydrochloride DRUG

Injected subcutaneously for skin graft harvesting

Group 2

Eligibility Criteria

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

You may qualify if:

• Spanish/English speaking
• \<20%TBSA; \<5% TBSA deep partial or full thickness burns

You may not qualify if:

• chronic pain syndrome
• \> 20% TBSA burn injury; \> 5% TBSA deep partial or full thickness burn
• pregnant
• allergy to lidocaine or other local anesthetics
• burns to anterior thighs

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• Egan KG, Guest R, Sinik LM, Nazir N, De Ruyter M, Ponnuru S, Bhavsar D. Evaluation of Liposomal Bupivacaine at Split-Thickness Skin Graft Donor Sites Through a Randomized, Controlled Trial. J Burn Care Res. 2021 Nov 24;42(6):1280-1285. doi: 10.1093/jbcr/irab129.

  PMID: 34216466 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Burns

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dhaval Bhavsar
• Organization: University of Kansas Medical Center

dbhavsar@kumc.edu

9135882000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only subjects in first phase will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director Burnett Burn Center, Department of Plastic Surgery Associate Professor

Model Details: Phase 1 -randomized pre-operatively to receive either lidocaine or liposomal bupivicaine Phase 2- all enrolled into regional nerve block group

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 26, 2019
• Study Start: March 18, 2019
• Primary Completion: August 6, 2025
• Study Completion: October 27, 2025
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)