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

Rutgers The State University of New Jersey

Status: Terminated

Conditions: Other Biomechanical Lesions of Upper Extremity

Treatments: Procedure: Local anesthetic block [0.35% marcaine]; Device: Braun DIG-R-C Stimuplex Blockade Monitor System

Study type: Interventional

Funder types: Other

Identifiers

NCT03112642

0220110040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Standard Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Local anesthetic block [0.35% marcaine]

Test Group

Experimental group

Description:

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

Treatment:

Device: Braun DIG-R-C Stimuplex Blockade Monitor System

Procedure: Local anesthetic block [0.35% marcaine]