Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

NCT01377545 | Withdrawn Phase 4

• 1 other identifier: Infraclav Needle vs Catheter
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Block

Keywords

Infraclavicular; Nerve Block; Needle; Perineural Catheter; Volunteer; Upper Extremity Nerve Block; Sensation; Strength

Outcome Measures

Primary Outcomes (1)

• Sensory Level

  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 Outcomes (2)

• Grip Strength

  120 Minutes

• Sensory level for individual nerves

  120 Minutes

Study Arms (2)

Local Anesthetic Via Catheter

ACTIVE COMPARATOR

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.

Local Anesthetic Via Needle

ACTIVE COMPARATOR

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

Procedure: Local Anesthetic given via needle for infraclavicular nerve block

Interventions

Local Anesthetic given via perineural catheter for infraclavicular nerve block. PROCEDURE

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.

Local Anesthetic Via Catheter

Local Anesthetic given via needle for infraclavicular nerve block PROCEDURE

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.

Local Anesthetic Via Needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• willing to have bilateral infraclavicular blocks/catheters placed

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD CTRI, Hillcrest

San Diego, California, 92103, United States

Location

Study Officials

• Brian M Ilfeld, M.D., M.S.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, In Residence

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 21, 2011
• Study Start: January 1, 2013
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

US (1)