Nerve Stimulator for Patients With Upper Extremity Disease, Vascular or Orthopedic Surgery

NCT ID: NCT03112642

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2021-03-09

Brief Summary

To help determine if there is improved pain relief when a device that makes an arm muscle move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent feeling of pain (anesthesia) of the upper arm.

Detailed Description

The Investigators will use the assessment of onset of motor and sensory block Q 5 minutes to distinguish the difference between blocks performed with ultrasound guidance with or without a nerve blockade monitor.

Conditions

Other Biomechanical Lesions of Upper Extremity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Group

In the Standard Group, in the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block \[0.35% marcaine\] will be administered into the brachial plexus of the upper limb being operated on, at the supraclavicular level.

Group Type: ACTIVE_COMPARATOR

Local anesthetic block [0.35% marcaine]

Intervention Type: PROCEDURE

In the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block \[0.35% marcaine\] will be administered.

Test Group

In this group, the ultrasound guided local anesthetic block into the brachial plexus at the supraclavicular level of the upper limb being operated on will be supplemented by use of a blockade monitor (Nerve stimulator device) to direct final placement of the needle for the nerve block.

Only this group of the patients will receive this intervention with sufficient detail so that it can be distinguished from the Test Group

Group Type: EXPERIMENTAL

Local anesthetic block [0.35% marcaine]

Intervention Type: PROCEDURE

In the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block \[0.35% marcaine\] will be administered.

Braun DIG-R-C Stimuplex Blockade Monitor System

Intervention Type: DEVICE

The blockade system will be initially set at 1 milliamp. As the proximity of the tip of the needle to the components of the brachial plexus becomes evident by ultrasound approximation and the stimulation pattern of the hand and wrist, the output of the system will be reduced to .3-.5 milliamps. With use of the Braun DIG-R-C Stimuplex Blockade Monitor System.

Interventions

Local anesthetic block [0.35% marcaine]

In the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block \[0.35% marcaine\] will be administered.

Intervention Type: PROCEDURE

Braun DIG-R-C Stimuplex Blockade Monitor System

The blockade system will be initially set at 1 milliamp. As the proximity of the tip of the needle to the components of the brachial plexus becomes evident by ultrasound approximation and the stimulation pattern of the hand and wrist, the output of the system will be reduced to .3-.5 milliamps. With use of the Braun DIG-R-C Stimuplex Blockade Monitor System.

Intervention Type: DEVICE

Other Intervention Names

40 ml of local anesthetic block [0.35% marcaine]

Eligibility Criteria

Inclusion Criteria

• Adult male and females 21 through 89
• Agree to study participation and signed the informed consent
• Scheduled for upper extremity surgery with ultrasound guided supraclavicular block -

Exclusion Criteria

• Children
• Pregnant Women
• Persons with allergies to local anesthetics
• Persons with infections at or near site of needle insertion
• Patients with severe disturbance of cardiac rhythm and heart block
• Patients with severe respiratory compromise
• Patients requiring bilateral upper extremity anesthesia
• Patients with coagulopathy or medical anticoagulation
• Patients with traumatic nerve injury to neck or upper extremity
• Patients with preexisting neurological deficits in the distribution of the block
• Patients with previous surgery to the neck that may distort brachial plexus anatomy

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

William Grubb, M.D.

Principal Investigator, Associate Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Grubb, DDS, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Wood Johnson University Hospital

Locations

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0220110040

Identifier Type: -

Identifier Source: org_study_id