Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
- Conditions
- BurnsPain, Postoperative
- Interventions
- Registration Number
- NCT03854344
- Lead Sponsor
- University of Kansas Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- Spanish/English speaking
- <20%TBSA; <5% TBSA deep partial or full thickness burns
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1 Liposomal bupivacaine Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting Group 2 Lidocaine Hydrochloride Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting Group 3 Bupivacaine Hydrochloride 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
- Primary Outcome Measures
Name Time Method A measurement of post operative pain involving skin graft donor site using visual analog scale (VAS) ranging 0-10, at 8 hours post-operatively The subject completes a pain assessment 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
- Secondary Outcome Measures
Name Time Method 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 Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents
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 4,8, 12, 24, 48 and 72 hours after surgery. They will be compared between two groups. 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
Trial Locations
- Locations (1)
The University of Kansas Health System
🇺🇸Kansas City, Kansas, United States