Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Local Anesthetic Via Catheter
    • 30mL of Lidocaine (local Anesthetic) will be injected via a perineural catheter at hour 0.
  • Active Comparator: Local Anesthetic Via Needle
    • 30mL of Lidocaine (local Anesthetic) will be injected via a needle at hour 0.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence – University of California, San Diego
  • Overall Official(s)
    • Brian M Ilfeld, M.D., M.S., Principal Investigator, University of California, San Diego

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