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Not yet recruiting NCT06828601

Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

Phase IV Interventional Pain Management Burn Injury Lidocaine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IV Lidocaine, IV Saline.
Who it may be relevant to
Registry conditions: Pain Management, Burn Injury, Lidocaine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury: A Pilot Study to Investigate Analgesic and Opioid Sparing Effects

Overview

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).

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.

Primary outcome measures

  • Feasibility of Study for future larger RCT-Recruitment [Time frame: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Preliminary Data [Time frame: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Acceptability of Intervention [Time frame: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Data collection [Time frame: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Reliability of data [Time frame: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Outcomes [Time frame: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Complete Data collection [Time frame: Through study completion, an average of 6 months]
Secondary outcome measures (6)
  • Length of Hospital Stay [Time frame: Up to 50 weeks]
  • Adverse effects of lidocaine infusion [Time frame: 48 hours - During the lidocaine infusion]
  • Total MED [Time frame: MED assessed at 24-, 48-, and 72-hours post-operatively]
  • Pain Scores [Time frame: Scores assessed at 24-, 48-, and 72-hours post-operatively]
  • Quality of Recovery Scores [Time frame: Assessed 24-, 48-, and 72-hours post-operatively]
  • Brief Pain Inventory (Short Form) [Time frame: Assessed at 2 weeks post-operatively and at 3 months post-operatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06828601 · STUDY00018912

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗