Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain

University of Kansas

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative; Burns

Treatments: Drug: Lidocaine Hydrochloride; Drug: Bupivacaine Hydrochloride; Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03854344

143321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Liposomal bupivacaine

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine Hydrochloride

Group 3

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride