Pain ManagementPhase 4NCT06828601
Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury
A Phase 4 study testing IV Lidocaine and IV Saline in people with Pain Management and Burn Injury, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Burn Injury, Lidocaine
- What is being tested?
- IV Lidocaine and IV Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute burn patients
- 18 years or older
- <20% Total Body Surface Area
- Wound debridement surgery scheduled at Harborview Medical Center
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury: A Pilot Study to Investigate Analgesic and Opioid Sparing Effects
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:
Read more
- 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
- Pain Management, Burn Injury, Lidocaine
- Being tested
- IV Lidocaine, IV Saline
- Medical subject headings
- Agnosia, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV LidocaineDrug
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 SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IV Lidocaine |
| 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. Receives: Drug: IV Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Study for future larger RCT-Recruitment
Recruitment rate (screening and recruitment of 20 patients over 6 months)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 6 months
Feasibility of Study for future larger RCT-Outcomes
Review of current Secondary Outcome to determine if appropriate to become Primary Outcomes for future RCT
Measured: Through study completion, an average of 6 months
Feasibility of Study for future larger RCT-Complete Data collection
Determine completion rate of collected data
Measured: Through study completion, an average of 6 months
Secondary outcomes (6)
Length of Hospital Stay
This is calculated from the date admitted to the hospital to the date of hospital discharge.
Measured: Up to 50 weeks
Adverse effects of lidocaine infusion
Measured: 48 hours - During the lidocaine infusion
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 2 weeks post-operatively and at 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ireana Ng, University of Washington
- Investigators
- Ireana C Ng, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828601
- Sponsor's protocol ID
- STUDY00018912
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury: A Pilot Study to Investigate Analgesic and Opioid Sparing Effects
- ClinicalTrials.gov ID
- NCT06828601
- Acronym / sponsor ID
- STUDY00018912
- Conditions
- Pain Management, Burn Injury, Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Lidocaine | Active comparator | Drug: IV LidocaineParticipant 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 | Drug: IV SalineParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute burn patients
- 18 years or older
- <20% Total Body Surface Area
- Wound debridement surgery scheduled at Harborview Medical Center
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV LidocaineParticipant 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 Lidocaine |
| IV SalineParticipant 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. | Drug | IV Saline |
Primary outcome
Feasibility of Study for future larger RCT-Recruitment
Time frame: 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
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.
Feasibility of Study for future larger RCT-Acceptability of Intervention
Time frame: 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
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
Feasibility of Study for future larger RCT-Reliability of data
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.
Feasibility of Study for future larger RCT-Outcomes
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
Feasibility of Study for future larger RCT-Complete Data collection
Time frame: Through study completion, an average of 6 months
Determine completion rate of collected data
6 secondary outcomes
Length of Hospital Stay
Time frame: Up to 50 weeks
Adverse effects of lidocaine infusion
Time frame: 48 hours - During the lidocaine infusion
Total MED
Time frame: MED assessed at 24-, 48-, and 72-hours post-operatively
Pain Scores
Time frame: Scores assessed at 24-, 48-, and 72-hours post-operatively
Quality of Recovery Scores
Time frame: Assessed 24-, 48-, and 72-hours post-operatively
Brief Pain Inventory (Short Form)
Time frame: Assessed at 2 weeks post-operatively and at 3 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ireana C Ng, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Lidocaine and IV Saline in people with Pain Management and Burn Injury, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrienne James (206-744-4634, ajames1@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Study for future larger RCT-Recruitment (time frame: Through study completion, an average of 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.