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

Other Biomechanical Lesions of Upper Extremity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03112642
• Other study ID #: 0220110040
• Status: Terminated
• Phase: N/A
• Start date: November 2013
• Est. completion date: March 9, 2021

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 9, 2021
• Est. primary completion date: March 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Other Biomechanical Lesions of Upper Extremity

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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