Pain Management, Burn Injury, Lidocaine
Conditions
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).
Interventions
DRUGIV 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.
DRUGIV 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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Study for future larger RCT-Complete Data collection | Through study completion, an average of 6 months | Determine completion rate of collected data |
| Feasibility of Study for future larger RCT-Recruitment | Through study completion, an average of 6 months | Recruitment rate (screening and recruitment of 20 patients over 6 months) |
| Feasibility of Study for future larger RCT-Preliminary Data | 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. |
| Feasibility of Study for future larger RCT-Acceptability of Intervention | Through study completion, an average of 6 months | Review of randomization and blinding processes, including both patients and clinical provider's experience |
| Feasibility of Study for future larger RCT-Data collection | 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 |
| Feasibility of Study for future larger RCT-Reliability of data | 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. |
| Feasibility of Study for future larger RCT-Outcomes | Through study completion, an average of 6 months | Review of current Secondary Outcome to determine if appropriate to become Primary Outcomes for future RCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects of lidocaine infusion | 48 hours - During the lidocaine infusion | — |
| Total MED | 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. |
| Pain Scores | 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. |
| Quality of Recovery Scores | 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. |
| Brief Pain Inventory (Short Form) | 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. |
| Length of Hospital Stay | Up to 50 weeks | This is calculated from the date admitted to the hospital to the date of hospital discharge. |
Contacts
Primary ContactAdrienne James
Outcome results
None listed