Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative, Burns

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride
* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Phase 1 -randomized pre-operatively to receive either lidocaine or liposomal bupivicaine Phase 2- all enrolled into regional nerve block group
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. |