Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

• Sponsor: University of California, San Diego (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01377545
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Sensory level for individual nerves [120 Minutes]

   Evaluated using transcutaneous electrical stimulation (TES) in the same manner as described for the primary end point.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01377545
• Other Study ID Numbers: Infraclav Needle vs Catheter
• First Posted: Jun 21, 2011
• Last Update Posted: Jan 18, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, 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

Study Results

No Results Posted as of Jan 18, 2013