Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury.

NCT02229578 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB201400019OCR18920
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain

Keywords

Burn pain; lidocaine; donor site pain; Narcotic use

Outcome Measures

Primary Outcomes (2)

• Pain Change

  Improvement of pain perception for those receiving lidocaine vs those that do not. Pain will be measured by the Verbal Numerical Rating Scale (VNRS). This scale ranges from 0 to 10, with 0 being no pain and 10 being worst pain.

  24 hours

• Pain Change in 24 Hours (Self Reported Pain From Electronic Health Records)

  Pain will be measured by the Verbal Numerical Rating Scale (VNRS). This scale ranges from 0 to 10, with 0 being no pain and 10 being worst pain.

  Immediate post-op to 24 hours post op

Secondary Outcomes (1)

• Change in Hydromorphone in 24 Hours

  Immediate post-op to 24 hours post op

Study Arms (2)

Lidocaine Treatment Group

EXPERIMENTAL

Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.

Drug: Lidocaine

Placebo Treatment Group

PLACEBO COMPARATOR

Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.

Drug: Placebo

Interventions

Lidocaine DRUG

Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.

Lidocaine Treatment Group

Placebo DRUG

Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.

Also known as: Saline

Placebo Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

Shands Hospital, University of Florida

Gainesville, Florida, 32601, United States

Location

Shands Hospital

Gainesville, Florida, 32603, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Brenda Fahy, MD
• Organization: University of Florida

bfahy@anest.ufl.edu

859-402-4360

Study Officials

• Brenda Fahy, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 1, 2014
• Study Start: September 1, 2014
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: July 1, 2024
• Results First Posted: July 1, 2024

Record last verified: 2024-06

Locations

US (2)