Nerve Stimulator for Patients With Upper Extremity Disease, Vascular or Orthopedic Surgery
- Conditions
- Other Biomechanical Lesions of Upper Extremity
- Interventions
- Procedure: Local anesthetic block [0.35% marcaine]Device: Braun DIG-R-C Stimuplex Blockade Monitor System
- Registration Number
- NCT03112642
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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 -
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Group Local anesthetic block [0.35% marcaine] 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. Test Group Local anesthetic block [0.35% marcaine] 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 Test Group Braun DIG-R-C Stimuplex Blockade Monitor System 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
- Primary Outcome Measures
Name Time Method Dermatomes With Complete Motor Block of the Upper Extremities at 30 Minutes 30 minutes post block 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States