- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377545
Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus
January 16, 2013 updated by: Brian M. Ilfeld, MD, MS, University of California, San Diego
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 Overview
Status
Withdrawn
Conditions
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 Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- UCSD CTRI, Hillcrest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age ≥ 18 years
- willing to have bilateral infraclavicular blocks/catheters placed
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Local Anesthetic Via Catheter
30mL of Lidocaine (local Anesthetic) will be injected via a perineural catheter at hour 0.
|
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.
|
Active Comparator: Local Anesthetic Via Needle
30mL of Lidocaine (local Anesthetic) will be injected via a needle at hour 0.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grip Strength
Time Frame: 120 Minutes
|
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.
|
120 Minutes
|
Sensory level for individual nerves
Time Frame: 120 Minutes
|
Evaluated using transcutaneous electrical stimulation (TES) in the same manner as described for the primary end point.
|
120 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
June 17, 2011
First Submitted That Met QC Criteria
June 20, 2011
First Posted (Estimate)
June 21, 2011
Study Record Updates
Last Update Posted (Estimate)
January 18, 2013
Last Update Submitted That Met QC Criteria
January 16, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Infraclav Needle vs Catheter
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nerve Block
-
Lawson Health Research InstituteUnknownInferior Alveolar Nerve Block | Greater Palatine Nerve BlockCanada
-
Diskapi Teaching and Research HospitalCompletedArthroscopic Shoulder Surgery | Suprascapular Nerve Block | Axillary Nerve BlockTurkey
-
Tanta UniversityRecruitingArthroscopic Shoulder Surgery | Anterior Suprascapular Nerve Block | Interscalene Nerve BlockEgypt
-
Bozyaka Training and Research HospitalCompletedPeripheral Nerve Block | Foot and Ankle Surgery | Popliteal Nerve BlockTurkey
-
Charite University, Berlin, GermanySuspendedAnesthesia, Local | Brachial Plexus Block | Nerve BlockGermany
-
Zagazig UniversityCompletedPericapsular Nerve Group Block (PENG Block) | Lumbar Erector Spinae Plane BlockEgypt
-
Ondokuz Mayıs UniversityCompletedAnesthesia, Local | Brachial Plexus Block | Nerve BlockTurkey
-
University Hospital, AntwerpCompletedSurgery | Anesthesia | Brachial Plexus Block | Nerve BlockBelgium
-
Menoufia UniversityCompletedPericapsular Nerve Group Block (PENG Block) | Lumbar Erector Spinae Plane BlockEgypt
-
Peking Union Medical College HospitalNot yet recruiting
Clinical Trials on Local Anesthetic given via perineural catheter for infraclavicular nerve block.
-
University of ParmaCompletedPostoperative Pain | Orthopedic Surgical ProceduresItaly
-
University of ParmaCompletedFoot Diseases | Injuries, Knee | Orthopedic Disorders | Injuries, Leg | Injuries, FootItaly
-
Children's Hospital of PhiladelphiaTerminatedInjury of Anterior Cruciate LigamentUnited States
-
University of Sao Paulo General HospitalUnknownArterial Occlusive Diseases
-
Centro Hospitalar do PortoUnknown
-
Cedars-Sinai Medical CenterRecruiting
-
University Health Network, TorontoCompleted
-
University of ParmaCompletedTrauma | Forearm Injuries | Orthopedic Surgery | Nerve Block | Upper ExtremityItaly
-
University of North Carolina, Chapel HillCompletedPain, PostoperativeUnited States