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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01716078
• Other study ID #: 365681-8
• Status: Withdrawn
• Phase: N/A
• First received: October 17, 2012
• Last updated: January 28, 2016
• Start date: November 2011

Study information

• Verified date: January 2016
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
United States	Fort Meade	Fort Meade	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compund Muscle Action Potential (CMAP) amplitude	measured for motor studies from baseline to peak in mV	1 day	No
Secondary	Distal Latency	the interval between the stimulation of a compound muscle and the observed response. Normal nerve conduction velocity is above 40 m/sec in the lower extremities and above 50 m/sec in the upper extremities, but age, muscle disease, temperature, and other factors can influence the velocity.	1 day	No
Secondary	Peak Latency	This represents conduction along the majority of the axons; It is recorded at the peak of the waveform response	1 day	No
Secondary	Onset Latency	This represents conduction along the fastest axons; It is recorded at the initial deflection from baseline	1 day	No