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Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03854344
Collaborator
(none)
65
Enrollment
1
Location
2
Arms
21.5
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine or Liposomal Bupivicaine 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine Hydrochloride
  • Drug: Liposomal bupivacaine
 Phase 4

Detailed Description

This study is a prospective, randomized controlled trial. Study subjects are blinded to their randomization to avoid bias. The control group will undergo split thickness autografting using the standard protocol, involving injection of lidocaine with epinephrine at the donor site. The experimental group will undergo injection of liposomal bupivacaine (Exparel) at the time of harvest of the skin graft. Baseline pain levels will be obtained for all subjects using a validated pain assessment 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 group will then be 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 two groups.

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized pre-operatively to receive either lidocaine or liposomal bupivicainerandomized pre-operatively to receive either lidocaine or liposomal bupivicaine
Masking:
Single (Participant)
Masking Description:
Only subjects 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.
Primary Purpose:
Treatment
Official Title:
Prospective Study of Liposomal Bupivacaine for Pain Control of Split Thickness Skin Graft Donor Sites
Actual Study Start Date :
Mar 18, 2019
Actual Primary Completion Date :
Dec 19, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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
Injected subcutaneously for skin graft harvesting
Other Names:
  • Exparel

    		•
    Active Comparator: Group 2

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

    Drug: Lidocaine Hydrochloride
    Injected subcutaneously for skin graft harvesting

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Kansas Health System Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • University of Kansas Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dhaval Bhavsar, Medical Director Burnett Burn Center, Department of Plastic Surgery Associate Professor, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT03854344
    Other Study ID Numbers:
    • 143321
    First Posted:
    Feb 26, 2019
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Pain, Postoperative
    Lidocaine
    Bupivacaine

    Study Results

    No Results Posted as of May 12, 2021