Trial Outcomes & Findings for Nerve Stimulator for Patients With Upper Extremity Disease, Vascular or Orthopedic Surgery (NCT NCT03112642)

Last Updated: 2024-03-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

30 minutes post block

Results posted on

2024-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	6	2
Overall Study COMPLETED	6	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Group n=6 Participants 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.	Test Group n=2 Participants 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.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=6 Participants	2 Participants n=2 Participants	5 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=6 Participants	0 Participants n=2 Participants	3 Participants n=8 Participants
Age, Continuous	68.3 years STANDARD_DEVIATION 12.86 • n=6 Participants	61.5 years STANDARD_DEVIATION 1.5 • n=2 Participants	66.6 years STANDARD_DEVIATION 11.55 • n=8 Participants
Sex: Female, Male Female	0 Participants n=6 Participants	1 Participants n=2 Participants	1 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=6 Participants	1 Participants n=2 Participants	7 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 participants n=6 Participants	2 participants n=2 Participants	8 participants n=8 Participants

PRIMARY outcome

Timeframe: 30 minutes post block

Population: Dermatomes

Outcome measures

Outcome measures
Measure	Standard Group n=18 dermatomes 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.	Test Group n=6 dermatomes 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.
Dermatomes With Complete Motor Block of the Upper Extremities at 30 Minutes	18 dermatomes	6 dermatomes

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 minutes post block

Population: Dermatomes with a 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.

Outcome measures

Outcome measures
Measure	Standard Group n=18 dermatomes 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.	Test Group n=6 dermatomes 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.
Dermatomes With Response to Fine Touch at 30 Minutes	18 dermatomes	6 dermatomes

Adverse Events

Standard Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William R Grubb MD

RutgersSUNJ

Phone: 7327426528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place