Other Biomechanical Lesions of Upper Extremity
Conditions
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.
Interventions
PROCEDURELocal 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.
DEVICEBraun 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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dermatomes With Response to Fine Touch at 30 Minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 6 |
| 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
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.
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. | 2 |
| Total | 8 |
Baseline characteristics
| Characteristic | Test Group | Total | Standard Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 5 Participants | 3 Participants |
| Age, Continuous | 61.5 years STANDARD_DEVIATION 1.5 | 66.6 years STANDARD_DEVIATION 11.55 | 68.3 years STANDARD_DEVIATION 12.86 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 participants | 8 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 7 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 2 |
| other Total, other adverse events | 0 / 6 | 0 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 2 |
Outcome results
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.
Time frame: 30 minutes post block
Population: Dermatomes
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Standard Group | Dermatomes With Complete Motor Block of the Upper Extremities at 30 Minutes | 18 dermatomes |
| Test Group | Dermatomes With Complete Motor Block of the Upper Extremities at 30 Minutes | 6 dermatomes |
Other Pre-specified
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.
Time frame: 30 minutes post block
Population: Dermatomes with a response to fine touch at 30 minutes
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Standard Group | Dermatomes With Response to Fine Touch at 30 Minutes | 18 dermatomes |
| Test Group | Dermatomes With Response to Fine Touch at 30 Minutes | 6 dermatomes |