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

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ClinicalTrials.gov Identifier: NCT03112642
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
William Grubb, M.D., Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Other Biomechanical Lesions of Upper Extremity Procedure: Local anesthetic block [0.35% marcaine] Device: Braun DIG-R-C Stimuplex Blockade Monitor System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does the Use of a Nerve Stimulator Improve the Outcome of Ultrasound-Guided Supraclavicular Block (Anesthesia) for Upper Extremity Surgery?
Study Start Date : November 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Muscle Strength [ Time Frame: 30 minutes post block ]
    The investigators will be assessing changes between muscle strength in the myotomal distribution of the upper limb corresponding to the anesthetized 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.


Secondary Outcome Measures :
  1. Hot cold discrimination [ Time Frame: 30 minutes post block ]
    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.


Other Outcome Measures:
  1. response to fine touch provocation [ Time Frame: 30 minutes post block ]
    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.



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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112642


Contacts
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Contact: William Grubb, DDS, MD 732-235-7827 wrgrubb@aol.com
Contact: Ann Marie Lozano, RN, MSN 732-235-3527 annmarie.lozano@rutgers.edu

Locations
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United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Ann Maire Lozano, RN, MSN    732-235-3526    lozanoan@rutgers.edu   
Contact: William Grubb, DDS, MD    732-235-7827    wrgrubb@aol.com   
Sub-Investigator: Dennis Hall, MD         
Sub-Investigator: Geza Kiss, MD         
Sub-Investigator: Sloan Yeh, MD         
Sub-Investigator: Scott Mellender, MD         
Sub-Investigator: Candy Amin, MD         
Sub-Investigator: Ann Marie Lozano, RN, MSN         
Sub-Investigator: Daniel J Ramos, BS         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: William Grubb, DDS, MD Robert Wood Johnson University Hospital

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Responsible Party: William Grubb, M.D., Principal Investigator, Associate Professor of Anesthesiology, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03112642     History of Changes
Other Study ID Numbers: 0220110040
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Anesthetics
Bupivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents