PainPhase 1/2NCT03117166
Effect of Intravenous Lidocaine, Used to Attenuate Pain With Propofol Injection, on Defibrillation Threshold Testing
A Phase 1/2 study testing lidocaine in people with Pain, run by Drexel University College of Medicine at 1 site in United States.
Trial summary
The use of lidocaine, as an anesthetic drug, during implantation of an implantable cardioverter-defibrillator(ICD)will not result in a clinically significant alteration of the defibrillation threshold during ICD placement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- 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
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any person referred to the Hahnemann University Hospital Electrophysiology Laboratory for a clinically indicated ICD implant
Who cannot join
- Any person under the age of 18 years
- Inability to give an informed consent
- Allergy to lidocaine
- Receiving lidocaine treatment for pain or arrhythmia
- Contraindication for DFT testing
- Not consenting for DFT testing
Show all 15Show fewer
- Receiving energy other than 10-12.5 joules as initial DFT test
- Implant of ICD on the right side
- DFT not planned to be performed during ICD implant
- Epicardial placement of ICD leads
- Use of single coil ICD lead
- Subpectoral ICD implantation
- Cephalic cutdown used for central venous access
- Require more than 3mg/kg of 1% SQ lidocaine for local anesthesia
- Pregnant women or prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
About this study
The use of lidocaine, as an anesthetic drug, during implantation of an implantable cardioverter-defibrillator(ICD)will not result in a clinically significant alteration of the defibrillation threshold during ICD placement.
Read the detailed description
Summary: The purpose is to observe the incidence of successful defibrillation on the first attempt during implantation of an implantable cardioverter-defibrillator (ICD) among patients who receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose.
During implantation of an ICD, defibrillation threshold (DFT) testing is performed. DFT is calibrated as the lowest energy delivered by the ICD that will successfully terminate malignant arrhythmia. Lidocaine, a routine anesthetic agent, is also identified as an antiarrhythmic drug. Experimentally, lidocaine has been shown to increase thresholds during DFT' testing due to the drugs dual effect. The rationale behind this project is that the lidocaine may yield falsely elevated DFT, resulting in higher calibration of the ICD device. This alteration can affect ICD battery and overall ICD life. Comparisons between study groups may elucidate effects of IV lidocaine on DFT.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
A one time bolus of lidocaine 0.5 mg/kg iv will be administered just prior to IV propofol injection,then successful defibrillation will be ascertained
PlaceboDrug
Also called Saline
A control group will get an IV bolus of 0.9% NS just prior to IV bolus of propofol, then successful defibrillation will be ascertained
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | treatment arm Receives: Drug: lidocaine |
| Saline | Placebo comparator | placebo arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of successful defibrillation on first attempt with 10-12 joules.
These patients will receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose. Outcome is to have a success defibrillation within the first attempt.
Measured: Through study completion but no longer than 1 year
Secondary outcomes (2)
Incidence of failure to defibrillate at higher energy levels.
This outcome occurs when research team fails to defibrillate on any attempt.
Measured: Through study completion but no longer than 1 year
Defibrillation threshold (DFT) for subjects who fail to defibrillate at the initial 10-12 joules.
This outcome occurs when research team fails to defibrillate on first attempt.
Measured: Through study completion but no longer than 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: multidisciplinary participation could not be overcome.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryan Chambers, Principal investigator, Drexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117166
- Sponsor's protocol ID
- 17283
- Status last verified
- May 2017
- First submitted
- 24 May 2011
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lidocaine, Used to Attenuate Pain With Propofol Injection, on Defibrillation Threshold Testing
- ClinicalTrials.gov ID
- NCT03117166
- Acronym / sponsor ID
- 17283
- Conditions
- Pain
- Keywords
- lidocaine implantation ICD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: multidisciplinary participation could not be overcome.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Apr 2017 (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 use of lidocaine, as an anesthetic drug, during implantation of an implantable cardioverter-defibrillator(ICD)will not result in a clinically significant alteration of the defibrillation threshold during ICD placement.
Detailed description
Summary: The purpose is to observe the incidence of successful defibrillation on the first attempt during implantation of an implantable cardioverter-defibrillator (ICD) among patients who receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose.
During implantation of an ICD, defibrillation threshold (DFT) testing is performed. DFT is calibrated as the lowest energy delivered by the ICD that will successfully terminate malignant arrhythmia. Lidocaine, a routine anesthetic agent, is also identified as an antiarrhythmic drug. Experimentally, lidocaine has been shown to increase thresholds during DFT' testing due to the drugs dual effect. The rationale behind this project is that the lidocaine may yield falsely elevated DFT, resulting in higher calibration of the ICD device. This alteration can affect ICD battery and overall ICD life. Comparisons between study groups may elucidate effects of IV lidocaine on DFT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: lidocainetreatment arm |
| Saline | Placebo comparator | Drug: Placeboplacebo arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any person referred to the Hahnemann University Hospital Electrophysiology Laboratory for a clinically indicated ICD implant
Key exclusion criteria (15 listed)
- Any person under the age of 18 years
- Inability to give an informed consent
- Allergy to lidocaine
- Receiving lidocaine treatment for pain or arrhythmia
- Contraindication for DFT testing
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 |
|---|---|---|
| lidocaineA one time bolus of lidocaine 0.5 mg/kg iv will be administered just prior to IV propofol injection,then successful defibrillation will be ascertained | Drug | Lidocaine |
| PlaceboAlso: SalineA control group will get an IV bolus of 0.9% NS just prior to IV bolus of propofol, then successful defibrillation will be ascertained | Drug | Saline |
Primary outcome
Incidence of successful defibrillation on first attempt with 10-12 joules.
Time frame: Through study completion but no longer than 1 year
These patients will receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose. Outcome is to have a success defibrillation within the first attempt.
2 secondary outcomes
Incidence of failure to defibrillate at higher energy levels.
Time frame: Through study completion but no longer than 1 year
Defibrillation threshold (DFT) for subjects who fail to defibrillate at the initial 10-12 joules.
Time frame: Through study completion but no longer than 1 year
Results and safety
The study was stopped early (reason given: multidisciplinary participation could not be overcome.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Bryan Chambers principal investigator
Drexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lidocaine in people with Pain, run by Drexel University College of Medicine 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 1 inclusion and 15 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: stopped early, as of the sponsor's last update on 9 May 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: multidisciplinary participation could not be overcome.). Results are not available in the source record.
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?
Incidence of successful defibrillation on first attempt with 10-12 joules. (time frame: Through study completion but no longer than 1 year). 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 9 May 2017.