Trials / Not Yet Recruiting
Not Yet RecruitingNCT06828601
Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury
Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury: A Pilot Study to Investigate Analgesic and Opioid Sparing Effects
- Status
- Not Yet Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
- First posted
- 2025-02-14
- Last updated
- 2025-04-04
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06828601. Inclusion in this directory is not an endorsement.