Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
Primary Purpose
Pain, Postoperative, Burns
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine Hydrochloride
Liposomal bupivacaine
Bupivacaine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
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
Sites / Locations
- The University of Kansas Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT03854344
First Posted
February 8, 2019
Last Updated
December 28, 2022
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03854344
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Phase 1 -randomized pre-operatively to receive either lidocaine or liposomal bupivicaine Phase 2- all enrolled into regional nerve block group
Masking
Participant
Masking Description
Only subjects in first phase will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future.
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Arm Title
Group 3
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Intervention Description
Injected subcutaneously for skin graft harvesting
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Injected subcutaneously for skin graft harvesting
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Used for regional nerve block for skin graft harvesting
Primary Outcome Measure Information:
Title
A measurement of post operative pain involving skin graft donor site using visual analog scale (VAS) ranging 0-10, at 8 hours post-operatively
Description
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
Time Frame
The subject completes a pain assessment at 8 hours post-operatively.
Secondary Outcome Measure Information:
Title
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
Description
Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents
Time Frame
72 hours (3 days) post operatively
Title
Pain Scores over 72 hours after surgery
Description
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
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Reynolds, BSN
Phone
913-588-0068
Email
jreynolds11@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dhaval Bhavsar, MD
Phone
913-588-2000
Email
dbhavsar@kumc.edu
Facility Information:
Facility Name
The University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanna Julo, BA
Phone
913-945-6861
Email
jjulo@kumc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34216466
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.
Results Reference
derived
Learn more about this trial
Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
We'll reach out to this number within 24 hrs