Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

Phase 4

Withdrawn

• Conditions: Nerve Block
• Interventions: Procedure: Local Anesthetic given via perineural catheter for infraclavicular nerve block.; Procedure: Local Anesthetic given via needle for infraclavicular nerve block

• Registration Number: NCT01377545
• Lead Sponsor: University of California, San Diego

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 Timeline

• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-21
• Status Verified: 2013-01
• Study Start: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anesthetic Via Catheter	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	Local Anesthetic given via needle for infraclavicular nerve block	30mL of Lidocaine (local Anesthetic) will be injected via a needle at hour 0.

Primary Outcome Measures

Name	Time	Method
Sensory Level	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 Outcome Measures

Name	Time	Method
Grip Strength	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	120 Minutes	Evaluated using transcutaneous electrical stimulation (TES) in the same manner as described for the primary end point.

Trial Locations

Locations (1)

UCSD CTRI, Hillcrest; 🇺🇸 San Diego, California, United States