Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

NCT ID: NCT06828601

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

IV Lidocaine

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

IV Saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Acute burn patients
• 18 years or older
• <20% Total Body Surface Area
• Wound debridement surgery scheduled at Harborview Medical Center

Exclusion Criteria

• History of polysubstance use
• Chronic opioid use (MED>40mg for more than 6 weeks)
• Cases where the known clinical standard care would be to keep patient intubated postoperatively
• Cases where the known clinical standard care would avoid IV Lidocaine infusion
• Allergy to amide local anesthetics
• Any elevated risk for local anesthetic systemic toxicity as determined by the study team
• Cardiac arrythmias or cardiovascular instability (e.g. shock)
• Severe renal or hepatic impairment
• Pregnancy
• Local anesthesia will be given by another route (e.g. nerve block)
• Prisoners
• Non-English Speaking/reading

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ireana Ng

Assistant Professor, Anesthesiology & Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ireana C Ng, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

Adrienne James

Role: CONTACT

ajames1@uw.edu

206-744-4634

Other Identifiers

STUDY00018912

Identifier Type: -

Identifier Source: org_study_id