Clinical trial NCT06828601: Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury
Official title: Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury: A Pilot Study to Investigate Analgesic and Opioid Sparing Effects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pain Management
Burn Injury
Lidocaine
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Feasibility of Study for future larger RCT-Recruitment
timeFrame: Through study completion, an average of 6 months
measure: Feasibility of Study for future larger RCT-Preliminary Data
timeFrame: Through study completion, an average of 6 months
measure: Feasibility of Study for future larger RCT-Acceptability of Intervention
timeFrame: Through study completion, an average of 6 months
measure: Feasibility of Study for future larger RCT-Data collection
timeFrame: Through study completion, an average of 6 months
measure: Feasibility of Study for future larger RCT-Reliability of data
timeFrame: Through study completion, an average of 6 months
measure: Feasibility of Study for future larger RCT-Outcomes
timeFrame: Through study completion, an average of 6 months
measure: Feasibility of Study for future larger RCT-Complete Data collection
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Up to 50 weeks
measure: Adverse effects of lidocaine infusion
timeFrame: 48 hours - During the lidocaine infusion
measure: Total MED
timeFrame: MED assessed at 24-, 48-, and 72-hours post-operatively
measure: Pain Scores
timeFrame: Scores assessed at 24-, 48-, and 72-hours post-operatively
measure: Quality of Recovery Scores
timeFrame: Assessed 24-, 48-, and 72-hours post-operatively
measure: Brief Pain Inventory (Short Form)
timeFrame: Assessed at 2 weeks post-operatively and at 3 months post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Ireana C Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: