Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain

Prospective Study of Liposomal Bupivacaine for Pain Control of Split Thickness Skin Graft Donor Sites

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Burns
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Lidocaine Hydrochloride; Drug: Bupivacaine Hydrochloride

Detailed Description

The first phase of the study was a randomized controlled study. In the second phase, all subjects will receive fascia iliaca, lateral femoral cutaneous, or femoral nerve blocks based on the proposed donor site location and will be compared to historic controls from the first phase. In the first phase, the control group underwent split thickness autografting using the standard protocol, involving injection of lidocaine with epinephrine at the donor site. In the first phase, the experimental group underwent injection of liposomal bupivacaine (Exparel) at the time of harvest of the skin graft. In the second phase, patients will undergo preoperative regional anesthesia with a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location rather than the standard protocol of lidocaine with epinephrine at the donor site. Thus, in the second phase, group 3 (preoperative block group) will be compared to historic controls which received the standard of care in the first phase of this trial. Baseline pain levels will be obtained for all subjects using a validated pain assessment scale, the Visual Analog Pain Scale. Postoperatively, time to first opioid pain medication (excluding immediate postoperative recovery from anesthesia), total opioid consumption on a daily basis, and donor site interval pain scores using a validated pain assessment scale will be obtained. The experimental groups will then be individually compared to the control group to determine if there is a significant difference in pain levels, time to first opioid, and overall opioid consumption between the groups.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dhaval Bhavsar, MD; Phone Number: 913-588-2000; Email: dbhavsar@kumc.edu
• Study Contact Backup: Name: Jessica Reynolds, BSN; Phone Number: 913-588-0068; Email: jreynolds11@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • The University of Kansas Health System
      • Contact: Jeanna Julo, BA; Phone Number: 913-945-6861; Email: jjulo@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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; Injected subcutaneously for skin graft harvesting; Other Names: Exparel
Active Comparator: Group 2; Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting	Drug: Lidocaine Hydrochloride; Injected subcutaneously for skin graft harvesting
Experimental: Group 3; 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; Used for regional nerve block for skin graft harvesting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents	72 hours (3 days) post operatively
Pain Scores over 72 hours after surgery	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	Pain scores associated with skin graft donor site will be assessed using Visual Analog Scale (0-10) at 4,8, 12, 24, 48 and 72 hours after surgery. They will be compared between two groups.

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: 143321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No