Clinical trial NCT03854344: Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
Official title: Prospective Study of Liposomal Bupivacaine for Pain Control of Split Thickness Skin Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Burns
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1 -randomized pre-operatively to receive either lidocaine or liposomal bupivicaine Phase 2- all enrolled into regional nerve block group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: A measurement of post operative pain involving skin graft donor site using visual analog scale (VAS) ranging 0-10, at 8 hours post-operatively
timeFrame: The subject completes a pain assessment at 8 hours post-operatively.
Secondary outcomes:
measure: 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
timeFrame: 72 hours (3 days) post operatively
measure: Pain Scores over 72 hours after surgery
timeFrame: 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.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Health System
state: Kansas
Study officials:
References:
citation: 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.