Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03854344
• Other study ID #: 143321
• Status: Recruiting
• Phase: Phase 4
• Start date: March 18, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Kansas Medical Center
• Contact: Jessica Reynolds, BSN
• Phone: 913-588-0044
• Email: jreynolds11[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Pain, Postoperative

Intervention

Drug:
• Lidocaine Hydrochloride
Injected subcutaneously for skin graft harvesting
• Liposomal bupivacaine
Injected subcutaneously for skin graft harvesting
• Bupivacaine Hydrochloride
Used for regional nerve block for skin graft harvesting

Locations

Country	Name	City	State
United States	The University of Kansas Health System	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.