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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

Tracking Information
First Submitted Date  ICMJE September 3, 2014
First Posted Date  ICMJE April 13, 2017
Last Update Posted Date September 5, 2018
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03112642 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 7, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Nerve Stimulator for Patients With Upper Extremity Disease, Vascular or Orthopedic Surgery
Official Title  ICMJE Does the Use of a Nerve Stimulator Improve the Outcome of Ultrasound-Guided Supraclavicular Block (Anesthesia) for Upper Extremity Surgery?
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Other Biomechanical Lesions of Upper Extremity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: 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

    Interventions:
    • Procedure: Local anesthetic block [0.35% marcaine]
    • Device: Braun DIG-R-C Stimuplex Blockade Monitor System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: William Grubb, DDS, MD 732-235-7827 wrgrubb@aol.com
Contact: Ann Marie Lozano, RN, MSN 732-235-3527 annmarie.lozano@rutgers.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03112642
Other Study ID Numbers  ICMJE 0220110040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Grubb, M.D., Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Grubb, DDS, MD Robert Wood Johnson University Hospital
PRS Account Rutgers, The State University of New Jersey
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP