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Clinical Trials/NCT01377545
NCT01377545WithdrawnPhase 4

Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

University of California, San Diego1 site in 1 countryStarted: January 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Locations
1
Primary Endpoint
Sensory Level

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Local Anesthetic Via Catheter

Active Comparator

30mL of Lidocaine (local Anesthetic) will be injected via a perineural catheter at hour 0.

Intervention: Local Anesthetic given via perineural catheter for infraclavicular nerve block. (Procedure)

Local Anesthetic Via Needle

Active Comparator

30mL of Lidocaine (local Anesthetic) will be injected via a needle at hour 0.

Intervention: Local Anesthetic given via needle for infraclavicular nerve block (Procedure)

Outcomes

Primary Outcomes

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 Outcomes

  • Grip Strength(120 Minutes)
  • Sensory level for individual nerves(120 Minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brian M. Ilfeld, MD, MS

Associate Professor, In Residence

University of California, San Diego

Study Sites (1)

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