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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Lidocaine | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Study for future larger RCT-Recruitment | Recruitment rate (screening and recruitment of 20 patients over 6 months) | Through study completion, an average of 6 months |
| 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. | Through study completion, an average of 6 months |
| Feasibility of Study for future larger RCT-Acceptability of Intervention | Review of randomization and blinding processes, including both patients and clinical provider's experience | Through study completion, an average of 6 months |
| 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 | Through study completion, an average of 6 months |
| Feasibility of Study for future larger RCT-Reliability of data | 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. | Through study completion, an average of 6 months |
| Feasibility of Study for future larger RCT-Outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | This is calculated from the date admitted to the hospital to the date of hospital discharge. | Up to 50 weeks |
| Adverse effects of lidocaine infusion | 48 hours - During the lidocaine infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrienne James | Contact | 206-744-4634 | ajames1@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ireana C Ng, MD | University of Washington | Principal Investigator |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D002056 | Burns |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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. |
|
Review of current Secondary Outcome to determine if appropriate to become Primary Outcomes for future RCT
| Through study completion, an average of 6 months |
| Feasibility of Study for future larger RCT-Complete Data collection | Determine completion rate of collected data | Through study completion, an average of 6 months |
| 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. | MED assessed at 24-, 48-, and 72-hours post-operatively |
| 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. | Scores assessed at 24-, 48-, and 72-hours post-operatively |
| Quality of Recovery Scores | 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. | Assessed 24-, 48-, and 72-hours post-operatively |
| Brief Pain Inventory (Short Form) | 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. | Assessed at 2 weeks post-operatively and at 3 months post-operatively |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |