Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

This study has been withdrawn prior to enrollment.
(lack of funding)
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01377545
First received: June 17, 2011
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Nerve Block
Procedure: Local Anesthetic given via perineural catheter for infraclavicular nerve block.
Procedure: Local Anesthetic given via needle for infraclavicular nerve block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Sensory Level [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Grip Strength [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
    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.

  • Sensory level for individual nerves [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
    Evaluated using transcutaneous electrical stimulation (TES) in the same manner as described for the primary end point.


Enrollment: 0
Study Start Date: January 2013
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Local Anesthetic Via Catheter
30mL of Lidocaine (local Anesthetic) will be injected via a perineural catheter at hour 0.
Procedure: 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.
Active Comparator: Local Anesthetic Via Needle
30mL of Lidocaine (local Anesthetic) will be injected via a needle at hour 0.
Procedure: Local Anesthetic given via needle 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377545

Locations
United States, California
UCSD CTRI, Hillcrest
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
  More Information

No publications provided

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01377545     History of Changes
Other Study ID Numbers: Infraclav Needle vs Catheter
Study First Received: June 17, 2011
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Infraclavicular
Nerve Block
Needle
Perineural Catheter
Volunteer
Upper Extremity Nerve Block
Sensation
Strength

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014