Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

NCT06828601 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00018912
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (7)

• Feasibility of Study for future larger RCT-Recruitment

  Recruitment rate (screening and recruitment of 20 patients over 6 months)

  Through study completion, an average of 6 months

• Feasibility of Study for future larger RCT-Preliminary Data

  Review of preliminary data for calculation of a sample size, minimum number of subjects needed to enroll in a future RCT for adequate power.

  Through study completion, an average of 6 months

• Feasibility of Study for future larger RCT-Acceptability of Intervention

  Review of randomization and blinding processes, including both patients and clinical provider's experience

  Through study completion, an average of 6 months

• Feasibility of Study for future larger RCT-Data collection

  The suitability of the methods for data collection, which are In person visits at 24, 48 \& 72hr and likely phone/virtual follow-ups at 2 weeks and 3 months

  Through study completion, an average of 6 months

• Feasibility of Study for future larger RCT-Reliability of data

  The reliability of data collected for analysis of analgesic efficacy includes review of numerical pain scores, total morphine equivalent dose (MED), Quality of Recovery Scores (QoR-15), and Brief Pain Inventory (BPI). Analgesic efficacy is expressed as the NNT, the number of patients who need to receive the active drug for one to achieve at least 50% pain relief compared with placebo over a 4-6h treatment period.

  Through study completion, an average of 6 months

• Feasibility of Study for future larger RCT-Outcomes

  Review of current Secondary Outcome to determine if appropriate to become Primary Outcomes for future RCT

  Through study completion, an average of 6 months

• Feasibility of Study for future larger RCT-Complete Data collection

  Determine completion rate of collected data

  Through study completion, an average of 6 months

Secondary Outcomes (6)

• Length of Hospital Stay

  Up to 50 weeks

• Adverse effects of lidocaine infusion

  48 hours - During the lidocaine infusion

• Total MED

  MED assessed at 24-, 48-, and 72-hours post-operatively

• Pain Scores

  Scores assessed at 24-, 48-, and 72-hours post-operatively

• Quality of Recovery Scores

  Assessed 24-, 48-, and 72-hours post-operatively

Study Arms (2)

IV Lidocaine

ACTIVE COMPARATOR

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 Lidocaine

IV Saline

PLACEBO COMPARATOR

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.

Drug: IV Saline

Interventions

IV Lidocaine 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 Lidocaine

IV Saline 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.

IV Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

Agnosia; Burns

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ireana C Ng, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrienne James

CONTACT

206-744-4634; ajames1@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 14, 2025
• Study Start: April 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03