The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction

NCT01716078 | Withdrawn

• 1 other identifier: 365681-8
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the conducting ability of distal extremity nerves after a supraclavicular brachial plexus nerve block (with local anesthetic) has been placed at a more proximal location in the upper extremity.

Conditions

Anesthesia

Keywords

Brachial Plexus; Nerve Block; Nerve Conduction

Outcome Measures

Primary Outcomes (1)

• Compund Muscle Action Potential (CMAP) amplitude

  measured for motor studies from baseline to peak in mV

  1 day

Secondary Outcomes (3)

• Distal Latency

  1 day

• Peak Latency

  1 day

• Onset Latency

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female military health care beneficiaries age 18 years and older presenting for hand surgery and eligible for a brachial plexus nerve block will be asked to participate in this study.

You may qualify if:

• Male and female military health care beneficiaries 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy
• Written informed consent must be obtained from each patient prior to entering the study
• Patients must be willing to have a regional anesthetic nerve block placed prior to their scheduled procedure
• Patients must be willing to have neurodiagnostic tests performed prior to placement and after placement of the regional anesthesia nerve block

You may not qualify if:

• Refusal to have a brachial plexus nerve block placed
• Refusal to have serial nerve conduction studies performed
• Contraindication for a regional anesthesia nerve block (allergy to local anesthetic, infection at site of injection, elevated coagulation time)
• Presence of conditions affecting the hand or arm (e.g., injury, infection) that might preclude the performance of nerve conduction studies
• Presence of known major abnormalities of nerve conduction, e.g., absent median sensory potential in a patient scheduled for carpal tunnel release
• Presence of conditions affecting the contralateral hand or arm (e.g., injury, infection) that might preclude the performance of sensory and motor studies to test block or absence of a contralateral upper extremity

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead

Study Sites (1)

Fort Meade

Fort Meade, Maryland, 20755, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 29, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2014
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)