Thermal BurnsPhase 4NCT02059902
Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
A Phase 4 study testing Lidocaine in people with Thermal Burns, run by HealthPartners Institute at 1 site in United States.
Trial summary
Thermal injury results in one of the most intense and prolonged forms of pain the body can experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thermal Burns
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Feb 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Burn patient ≥ 18 years of age
- Burn patient scheduled to go to OR for excision and/or grafting procedure
Who cannot join
- Burn patient < 18 years of age
- Intubated patient on sedation drip
- Prolonged hypotension defined as Systolic Blood Pressure (SBP) < 90 mm/Hg for greater than 30 minutes in the pre-op area
- Severe underlying cardiovascular disease (documented ejection fraction < 40%)
- Documented conduction block, bradycardia or active congestive heart failure
- Documented active gastritis or ulcers
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- Previous steroid medication history if documented adrenal insufficiency
- Patient with documented liver disease
- Patient with epilepsy or known seizure disorder
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
About this study
Thermal injury results in one of the most intense and prolonged forms of pain the body can experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often underestimated. More medication may not be the answer, as relatively large doses of short acting opioids in the operative theater are associated with greater postoperative opioid consumption and higher pain scores. Furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and allodynia. Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic, and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used for perioperative pain management in a variety of surgical procedures. The design of this study will examine if lidocaine will reduce the pain scores and narcotic utilization in patients undergoing surgical procedures for burn injuries. The intervention group will receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The control group will get an equal volume of saline. The investigators will compare pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area (BSA) grafted.
- Conditions
- Thermal Burns
- Being tested
- Lidocaine, Placebo
- Keywords
- Pain management, Narcotic consumption, Skin graft
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Lidocaine infusion runs for a total of 24 hours
PlaceboOther
Normal saline runs for a total of 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Normal pain management | Placebo comparator | Normal saline (bolus followed by continuous infusion) Receives: Other: Placebo |
| Lidocaine | Experimental | Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour) Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Consumption (Measured in mg/kg Narcotic Consumption)
The infusion was initiated at 1.5mg/kg for 30 minutes prior to surgery start, followed by a 2.0 mg/kg/hr infusion at the time of incision start. The rate was reduced to 1.5mg/kg/hr for the remainder of the 24 hour period. A standardized post-operative pain management strategy (morphine and oxycodone) was followed by clinical staff, based on a standardized pain scale rating tool. The difference in narcotic consumption and number of pain medication doses over the 72-hour post-operative period was compared using an unadjusted Wilcoxon rank sum test due to non-normal data distribution.
Measured: 24-hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thermal BurnsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Mohr, MD, Principal investigator, Regions HospitalSandi Wewerka, MPH, Study director, Regions Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059902
- Sponsor's protocol ID
- 12-105
- Status last verified
- Jun 2018
- First submitted
- 10 Feb 2014
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
- ClinicalTrials.gov ID
- NCT02059902
- Acronym / sponsor ID
- 12-105
- Conditions
- Thermal Burns
- Keywords
- Pain management, Narcotic consumption, Skin graft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thermal injury results in one of the most intense and prolonged forms of pain the body can experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often underestimated. More medication may not be the answer, as relatively large doses of short acting opioids in the operative theater are associated with greater postoperative opioid consumption and higher pain scores. Furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and allodynia. Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic, and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used for perioperative pain management in a variety of surgical procedures. The design of this study will examine if lidocaine will reduce the pain scores and narcotic utilization in patients undergoing surgical procedures for burn injuries. The intervention group will receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The control group will get an equal volume of saline. The investigators will compare pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area (BSA) grafted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal pain management | Placebo comparator | Other: PlaceboNormal saline (bolus followed by continuous infusion) |
| Lidocaine | Experimental | Drug: LidocaineLidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Burn patient ≥ 18 years of age
- Burn patient scheduled to go to OR for excision and/or grafting procedure
Key exclusion criteria (10 listed)
- Burn patient < 18 years of age
- Intubated patient on sedation drip
- Prolonged hypotension defined as Systolic Blood Pressure (SBP) < 90 mm/Hg for greater than 30 minutes in the pre-op area
- Severe underlying cardiovascular disease (documented ejection fraction < 40%)
- Documented conduction block, bradycardia or active congestive heart failure
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 |
|---|---|---|
| LidocaineLidocaine infusion runs for a total of 24 hours | Drug | Lidocaine |
| PlaceboNormal saline runs for a total of 24 hours | Other | Normal pain management |
Primary outcome
Narcotic Consumption (Measured in mg/kg Narcotic Consumption)
Time frame: 24-hours post surgery
The infusion was initiated at 1.5mg/kg for 30 minutes prior to surgery start, followed by a 2.0 mg/kg/hr infusion at the time of incision start. The rate was reduced to 1.5mg/kg/hr for the remainder of the 24 hour period. A standardized post-operative pain management strategy (morphine and oxycodone) was followed by clinical staff, based on a standardized pain scale rating tool. The difference in narcotic consumption and number of pain medication doses over the 72-hour post-operative period was compared using an unadjusted Wilcoxon rank sum test due to non-normal data distribution.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
William Mohr, MD principal investigator
Regions Hospital
Sandi Wewerka, MPH study director
Regions Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Thermal Burns, run by HealthPartners Institute at 1 site in United States.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 7 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic Consumption (Measured in mg/kg Narcotic Consumption) (time frame: 24-hours post surgery). 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 3 Jul 2018.