Nerve BlockPhase 4NCT01377545
Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus
A Phase 4 study testing Local Anesthetic given via perineural catheter for infraclavicular nerve block. and Local Anesthetic given via needle for infraclavicular nerve block in people with Nerve Block, run by University of California, San Diego at 1 site in United States.
Trial summary
The investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nerve Block
- What is being tested?
- Local Anesthetic given via perineural catheter for infraclavicular nerve block. and Local Anesthetic given via needle for infraclavicular nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- willing to have bilateral infraclavicular blocks/catheters placed
Who cannot join
- current daily analgesic use
- opioid use within the previous 4 weeks
- any neuro-muscular deficit of either upper extremity
- body mass index > 30 kg/m2
- weight < 50 kg [100 lbs]
- pregnancy
- incarceration
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. The study results will help define the optimal local anesthetic bolus introduction technique-needle versus catheter-for peripheral nerve blocks when placing a perineural catheter.
Read the detailed description
Specific Aim: The investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. The study results will help define the optimal local anesthetic bolus introduction technique-needle versus catheter-for peripheral nerve blocks when placing a perineural catheter.
- Conditions
- Nerve Block
- Being tested
- Local Anesthetic given via perineural catheter for infraclavicular nerve block., Local Anesthetic given via needle for infraclavicular nerve block
- Keywords
- Infraclavicular, Nerve Block, Needle, Perineural Catheter, Volunteer, Upper Extremity Nerve Block, Sensation, Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthetic given via perineural catheter for infraclavicular nerve block.Procedure or surgery
Patients will be randomized to receive 30mL of Lidocaine via Catheter for an infraclavicular nerve block on one side (right or left) and via needle on the other side. Sensory and strength will be tested following local anesthetic administration.
Local Anesthetic given via needle for infraclavicular nerve blockProcedure or surgery
Patients will be randomized to receive 30mL of Lidocaine via Catheter for an infraclavicular nerve block on one side (right or left) and via needle on the other side. Sensory and strength will be tested following local anesthetic administration.
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthetic Via Catheter | Active comparator | 30mL of Lidocaine (local Anesthetic) will be injected via a perineural catheter at hour 0. Receives: Procedure: Local Anesthetic given via perineural catheter for infraclavicular nerve block. |
| Local Anesthetic Via Needle | Active comparator | 30mL of Lidocaine (local Anesthetic) will be injected via a needle at hour 0. Receives: Procedure: Local Anesthetic given via needle for infraclavicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Level
EKG pads will be positioned in the 5 major nerve distributions distal to the elbow, ensuring placement is equivalent bilaterally. The primary endpoint will be the time, in minutes, until all 5 nerve territories record > 60 mA, or 120 minutes-whichever occurs first-since 60 mA is estimated to be equivalent to a surgical incision.
Measured: 120 minutes
Secondary outcomes (2)
Grip Strength
Evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) of the hand/fingers. Subjects will be asked to take 2 sec to come to maximum effort, maintain this effort for 3 sec, and then relax.
Measured: 120 Minutes
Sensory level for individual nerves
Evaluated using transcutaneous electrical stimulation (TES) in the same manner as described for the primary end point.
Measured: 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, M.D., M.S., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377545
- Sponsor's protocol ID
- Infraclav Needle vs Catheter
- Status last verified
- Jan 2013
- First submitted
- 17 Jun 2011
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus
- ClinicalTrials.gov ID
- NCT01377545
- Acronym / sponsor ID
- Infraclav Needle vs Catheter
- Conditions
- Nerve Block
- Keywords
- Infraclavicular, Nerve Block, Needle, Perineural Catheter, Volunteer, Upper Extremity Nerve Block, Sensation, Strength
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Jun 2011 (estimated)
- 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 investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. The study results will help define the optimal local anesthetic bolus introduction technique-needle versus catheter-for peripheral nerve blocks when placing a perineural catheter.
Detailed description
Specific Aim: The investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. The study results will help define the optimal local anesthetic bolus introduction technique-needle versus catheter-for peripheral nerve blocks when placing a perineural catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anesthetic Via Catheter | Active comparator | Procedure: Local Anesthetic given via perineural catheter for infraclavicular nerve block.30mL of Lidocaine (local Anesthetic) will be injected via a perineural catheter at hour 0. |
| Local Anesthetic Via Needle | Active comparator | Procedure: Local Anesthetic given via needle for infraclavicular nerve block30mL of Lidocaine (local Anesthetic) will be injected via a needle at hour 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 years
- willing to have bilateral infraclavicular blocks/catheters placed
Key exclusion criteria (7 listed)
- current daily analgesic use
- opioid use within the previous 4 weeks
- any neuro-muscular deficit of either upper extremity
- body mass index > 30 kg/m2
- weight < 50 kg [100 lbs]
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 |
|---|---|---|
| Local Anesthetic given via perineural catheter for infraclavicular nerve block.Patients will be randomized to receive 30mL of Lidocaine via Catheter for an infraclavicular nerve block on one side (right or left) and via needle on the other side. Sensory and strength will be tested following local anesthetic administration. | Procedure or surgery | Local Anesthetic Via Catheter |
| Local Anesthetic given via needle for infraclavicular nerve blockPatients will be randomized to receive 30mL of Lidocaine via Catheter for an infraclavicular nerve block on one side (right or left) and via needle on the other side. Sensory and strength will be tested following local anesthetic administration. | Procedure or surgery | Local Anesthetic Via Needle |
Primary outcome
Sensory Level
Time frame: 120 minutes
EKG pads will be positioned in the 5 major nerve distributions distal to the elbow, ensuring placement is equivalent bilaterally. The primary endpoint will be the time, in minutes, until all 5 nerve territories record > 60 mA, or 120 minutes-whichever occurs first-since 60 mA is estimated to be equivalent to a surgical incision.
2 secondary outcomes
Grip Strength
Time frame: 120 Minutes
Sensory level for individual nerves
Time frame: 120 Minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
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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.
Brian M Ilfeld, M.D., M.S. principal investigator
University of California, San Diego
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 Local Anesthetic given via perineural catheter for infraclavicular nerve block. and Local Anesthetic given via needle for infraclavicular nerve block in people with Nerve Block, run by University of California, San Diego 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 7 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: withdrawn, as of the sponsor's last update on 18 Jan 2013. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sensory Level (time frame: 120 minutes). 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 18 Jan 2013.