Intermittent Compression Maneuver of Upper Arm to Reduce Axillary Brachial Plexus Block Onset Time
Intermittent Pneumatic Compression May Reduce Brachial Plexus Block Onset Time
1 other identifier
interventional
52
1 country
1
Brief Summary
This study evaluates the addition of intermittent pneumatic compression maneuver to axillary brachial plexus block in forearm and hand surgery. Half of participants will receive axillary brachial plexus block and intermittent pneumatic compression maneuver, while the other half will receive only axillary brachial plexus block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2019
CompletedFirst Submitted
Initial submission to the registry
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedAugust 14, 2019
August 1, 2019
1 year
August 9, 2019
August 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to achieve complete sensory block
Defined as the time to reach an absent sensation in the pinprick test at all four nerve distributions (ulnar nerve, radial nerve, median nerve, and musculocutaneous nerve)
1 hour
Secondary Outcomes (1)
Time to achieve surgical anaesthesia
1 hour
Study Arms (2)
Brachial plexus block with intermittent pneumatic compression
EXPERIMENTALHand and forearm surgery is performed after axillary brachial plexus block with intermittent pneumatic compression for 3 minutes.
Brachial plexus block
PLACEBO COMPARATORHand and forearm surgery is performed after axillary brachial plexus block only.
Interventions
Ultrasound guided axillary plexus block with 1.5% mepivacaine 30 ml
Following ultrasound guided axillary plexus block, the pneumatic compression maneuver of upper arm is composed of 6 repeated inflation-deflation periods; inflation with a pressure of 200 mmHg for 30 seconds and deflation for 10 seconds each.
Eligibility Criteria
You may qualify if:
- adults between ages of 20 and 50
- patients who are scheduled forearm and hand surgery with axillary brachial plexus block
- American Society of Anesthesiologists Physical Status classification 1 or 2
- patients who voluntarily agree to participate in the trial
You may not qualify if:
- patients who are pregnant or lactating
- patient who does not agree to participate in the study
- patient with side effects on local anesthetics
- patient with neurologic deficit of upper arm
- patients with comorbidities of cardiac, pulmonary, renal, cerebral, and hepatic systems
- patients with peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International St. Mary's Hospital
Incheon, 22711, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 14, 2019
Study Start
July 15, 2019
Primary Completion
July 15, 2020
Study Completion
October 15, 2020
Last Updated
August 14, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share