Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

University of Washington

Status and phase: Not yet enrolling; Phase 4

Conditions: Pain Management; Lidocaine; Burn Injury

Treatments: Drug: IV Lidocaine; Drug: IV Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06828601

STUDY00018912

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

IV Lidocaine

Active Comparator group

Description:

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.

Treatment:

Drug: IV Lidocaine

IV Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: IV Saline