Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

Phase 4

Not yet recruiting

• Conditions: Pain Management; Burn Injury; Lidocaine
• Interventions: Drug: IV Lidocaine; Drug: IV Saline

• Registration Number: NCT06828601
• Lead Sponsor: University of Washington

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Study Start: 2025-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Lidocaine	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.
IV Saline	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of Study for future larger RCT-Recruitment	Through study completion, an average of 6 months	Recruitment rate (screening and recruitment of 20 patients over 6 months)
Feasibility of Study for future larger RCT-Preliminary Data	Through study completion, an average of 6 months	Review of preliminary data for calculation of a sample size, minimum number of subjects needed to enroll in a future RCT for adequate power.
Feasibility of Study for future larger RCT-Acceptability of Intervention	Through study completion, an average of 6 months	Review of randomization and blinding processes, including both patients and clinical provider's experience
Feasibility of Study for future larger RCT-Data collection	Through study completion, an average of 6 months	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
Feasibility of Study for future larger RCT-Reliability of data	Through study completion, an average of 6 months	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.
Feasibility of Study for future larger RCT-Outcomes	Through study completion, an average of 6 months	Review of current Secondary Outcome to determine if appropriate to become Primary Outcomes for future RCT
Feasibility of Study for future larger RCT-Complete Data collection	Through study completion, an average of 6 months	Determine completion rate of collected data

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	Up to 50 weeks	This is calculated from the date admitted to the hospital to the date of hospital discharge.
Adverse effects of lidocaine infusion	48 hours - During the lidocaine infusion
Total MED	MED assessed at 24-, 48-, and 72-hours post-operatively	MED=Morphine Equivalent Dose. MED are values that represent the potency of an opioid dose relative to morphine. MED equates the many different opioids into a standard value that is based on morphine and its potency.
Pain Scores	Scores assessed at 24-, 48-, and 72-hours post-operatively	Pain Scores at rest and at movement provided by participant will be a numerical pain score from 0-10, with 0=no pain and 10-worst pain imaginable.
Quality of Recovery Scores	Assessed 24-, 48-, and 72-hours post-operatively	The Quality of Recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0-150 with 4 severity classes; excellent, good, moderate, and poor recovery.
Brief Pain Inventory (Short Form)	Assessed at 2 weeks post-operatively and at 3 months post-operatively	The Brief Pain Inventory-Short Form (BPI) is a 9-item self-administered questionnaire which rapidly assesses the severity of pain and it's impact on functioning.