Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

NCT06828601 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-04

No results posted yet for this study

Summary

The purpose of this study is to find out if IV lidocaine infusion decreases the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use in burn injury participants undergoing wound debridement in the operating room.

Participants will:

* be randomized to receive either an IV Lidocaine treatment or an IV Saline Placebo during their surgery. The IV treatment continues for 48 hours after surgery.
* be asked about their pain and how they're feeling at 4 timepoints during the 48 hours.
* be asked about their pain 2 weeks after surgery.

The participant and medical care providers will both be blinded to what IV treatment is being received.

Researchers will compare the 2 groups to see if IV Lidocaine helps decrease the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use (this includes opioid tolerance, opioid dependence, and opioid induced hyper-sensitivity to pain).

Conditions

  • Pain Management
  • Burn Injury
  • Lidocaine

Interventions

DRUG

IV Lidocaine

Participant receives IV Lidocaine during surgery. Infusion continues for 48 hours. An initial bolus dose of 1.5 mg/kg ideal body weight (IBW) of IV study infusion will be given at the start of surgery, followed by infusion rate of 2.0 mg/kg/hr IBW intraoperatively.This will be reduced to 1.5 mg/kg/hr IBW postoperatively for 48 hours - once the patient has reached recovery.

DRUG

IV Saline

Participant receives IV Saline (placebo) during surgery. Infusion continues for 48 hours. An initial bolus dose of 1.5 mg/kg ideal body weight (IBW) of IV study infusion will be given at the start of surgery, followed by infusion rate of 2.0 mg/kg/hr IBW intraoperatively.This will be reduced to 1.5 mg/kg/hr IBW postoperatively for 48 hours - once the patient has reached recovery.

Sponsors & Collaborators

Principal Investigators

  • Ireana C Ng, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828601 on ClinicalTrials.gov