Phase 4
N=34
Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury.
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02229578 ↗Enrolled (actual)
34
Serious AEs
25.0%
Results posted
Jul 2024
Primary outcome: Primary: Pain Change — -3.8; -4.0 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidocaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Change |
-3.8; -4.0 | <0.05 sig |
| PRIMARY Pain Change in 24 Hours (Self Reported Pain From Electronic Health Records) |
-2.1; -4.0 | <0.05 sig |
| SECONDARY Change in Hydromorphone in 24 Hours |
0.4; 4.7 | <0.05 sig |
Summary
Burn pain is known to be one the most severe forms of acute pain often requiring large amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for controlling pain in various settings including dressing changes of burns. The aim of this study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and narcotic requirements when applied to donor graft sites while at the same time not interfering with the standard of care TheraBond dressing. During this study the investiagtors will be monitoring for evidence of delayed wound healing, and surgical site infection.
Eligibility Criteria
Inclusion Criteria
- Adult patients who have suffered second to third degree burns requiring a single split thickness skin graft surgery.
- Donor sites will be between 3-15% TBSA.
Exclusion Criteria
- Patients who have history of chronic pain,
- opioid abuse history,
- major renal and/or liver dysfunction,
- history of seizures or major neurologic deficiencies,
- allergy to local anesthetics,
- reported allergy to hydromorphone,
- pregnancy, or
- currently have other injuries that significantly contribute to pain (i.e. multi-trauma patients) will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT02229578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.