Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

Nerve Block Clinical Trial

Official title:

Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01377545
• Other study ID #: Infraclav Needle vs Catheter
• Status: Withdrawn
• Phase: Phase 4
• First received: June 17, 2011
• Last updated: January 16, 2013
• Start date: January 2013
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nerve Block

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCSD CTRI, Hillcrest	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Grip Strength	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.	120 Minutes	No
Secondary	Sensory level for individual nerves	Evaluated using transcutaneous electrical stimulation (TES) in the same manner as described for the primary end point.	120 Minutes	No