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

Does the Use of a Nerve Stimulator Improve the Outcome of Ultrasound-Guided Supraclavicular Block (Anesthesia) for Upper Extremity Surgery?

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.

Study Overview

• Status: Terminated
• Conditions: Other Biomechanical Lesions of Upper Extremity
• Intervention / Treatment: Procedure: Local anesthetic block [0.35% marcaine]; Device: Braun DIG-R-C Stimuplex Blockade Monitor System

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Robert Wood Johnson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Other Names: 40 ml of local anesthetic block [0.35% marcaine]
Experimental: 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	Procedure: 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.; Other Names: 40 ml of local anesthetic block [0.35% marcaine]; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatomes With Complete Motor Block of the Upper Extremities at 30 Minutes	dermatomes (with full motor block) will be the outcome measure The investigators will be assessing changes between muscle strength in the myotomal distribution of the upper limb corresponding to the dermatome region of the brachial plexus following supraclavicular block, using the MRC power scale (medical research council scale, 0-5), with strength values obtained at time zero (initiation of the block), and to compared to subsequent measurements in 5 minute intervals until the final measurement at 30 minutes following the block.	30 minutes post block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hot cold discrimination	The investigators will be assessing changes in temperature sensation in the dermatomal distribution of the upper limb corresponding to the anesthetized region of the brachial plexus following supraclavicular block, using cold alcohol wipe and recording responses on a binary scale of sensation (can or cannot feel cold stimulus), with sensory values obtained at time zero (initiation of the block), and to compared to subsequent measurements in 5 minute intervals until the final measurement at 30 minutes following the block.	30 minutes post block

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatomes With Response to Fine Touch at 30 Minutes	The investigators are assessing changes response to fine touch provocation in the dermatomal distribution of the upper limb corresponding to the anesthetized region of the brachial plexus following supraclavicular block, using a sterile non penetrating (blunt tip) needle and recording responses on a binary scale of sensation (can or cannot feel fine touch stimulus), with sensory values obtained at time zero (initiation of the block), and to compared to subsequent measurements in 5 minute intervals until the final measurement at 30 minute following the block.	30 minutes post block

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: William Grubb, DDS, MD, Robert Wood Johnson University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 9, 2021
• Study Completion (Actual): March 9, 2021

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 0220110040