NCT Number: NCT06828601
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Through study completion, an average of 6 months
Recruitment rate (screening and recruitment of 20 patients over 6 months)
Time frame: Through study completion, an average of 6 months
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
Review of randomization and blinding processes, including both patients and clinical provider's experience
Time frame: Through study completion, an average of 6 months
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
The reliability of data collected for analysis of analgesic efficacy includes review of numerical pain scores, total morphine equivalent dose (MED), Quality of Recovery Scores (QoR-15), and Brief Pain Inventory (BPI). Analgesic efficacy is expressed as the NNT, the number of patients who need to receive the active drug for one to achieve at least 50% pain relief compared with placebo over a 4-6h treatment period.
Time frame: Through study completion, an average of 6 months
Review of current Secondary Outcome to determine if appropriate to become Primary Outcomes for future RCT
Time frame: Through study completion, an average of 6 months
Determine completion rate of collected data
Time frame: Up to 50 weeks
This is calculated from the date admitted to the hospital to the date of hospital discharge.
Time frame: 48 hours - During the lidocaine infusion
Time frame: MED assessed at 24-, 48-, and 72-hours post-operatively
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: Scores assessed at 24-, 48-, and 72-hours post-operatively
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: Assessed 24-, 48-, and 72-hours post-operatively
The Quality of Recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0-150 with 4 severity classes; excellent, good, moderate, and poor recovery.
Time frame: Assessed at 2 weeks post-operatively and at 3 months post-operatively
The Brief Pain Inventory-Short Form (BPI) is a 9-item self-administered questionnaire which rapidly assesses the severity of pain and it's impact on functioning.
Contact information is provided by the study sponsor or research team.
University of Washington
Other
Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury: A Pilot Study to Investigate Analgesic and Opioid Sparing Effects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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