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Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

ConditionsPain ManagementBurn InjuryLidocaine
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute burn patients

18 years or older

<20% Total Body Surface Area

Wound debridement surgery scheduled at Harborview Medical Center

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: IV LidocaineActive comparator 1 intervention
Group B: IV SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Study for future larger RCT-Recruitment

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

Time frame
Through study completion, an average of 6 months
2

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.

Time frame
Through study completion, an average of 6 months
3

Feasibility of Study for future larger RCT-Acceptability of Intervention

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

Time frame
Through study completion, an average of 6 months
4

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

Time frame
Through study completion, an average of 6 months

Secondary outcomes

1

Length of Hospital Stay

This is calculated from the date admitted to the hospital to the date of hospital discharge.

Time frame
Up to 50 weeks
2

Adverse effects of lidocaine infusion

Time frame
48 hours - During the lidocaine infusion
3

Total MED

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.

Time frame
MED assessed at 24-, 48-, and 72-hours post-operatively
4

Pain Scores

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: