Intermittent Compression Maneuver of Upper Arm to Reduce Axillary Brachial Plexus Block Onset Time

NCT ID: NCT04056585

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2020-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Forearm Injuries Hand Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Brachial plexus block with intermittent pneumatic compression

Hand and forearm surgery is performed after axillary brachial plexus block with intermittent pneumatic compression for 3 minutes.

Group Type EXPERIMENTAL

Ultrasound guided axillary plexus block

Intervention Type PROCEDURE

Ultrasound guided axillary plexus block with 1.5% mepivacaine 30 ml

Intermittent pneumatic compression maneuver

Intervention Type PROCEDURE

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.

Brachial plexus block

Hand and forearm surgery is performed after axillary brachial plexus block only.

Group Type PLACEBO_COMPARATOR

Ultrasound guided axillary plexus block

Intervention Type PROCEDURE

Ultrasound guided axillary plexus block with 1.5% mepivacaine 30 ml

Interventions

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Ultrasound guided axillary plexus block

Ultrasound guided axillary plexus block with 1.5% mepivacaine 30 ml

Intervention Type PROCEDURE

Intermittent pneumatic compression maneuver

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. adults between ages of 20 and 50
2. patients who are scheduled forearm and hand surgery with axillary brachial plexus block
3. American Society of Anesthesiologists Physical Status classification 1 or 2
4. patients who voluntarily agree to participate in the trial

Exclusion Criteria

1. patients who are pregnant or lactating
2. patient who does not agree to participate in the study
3. patient with side effects on local anesthetics
4. patient with neurologic deficit of upper arm
5. patients with comorbidities of cardiac, pulmonary, renal, cerebral, and hepatic systems
6. patients with peripheral vascular disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Catholic Kwandong University

OTHER

Sponsor Role lead

Responsible Party

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Hye-Won Jeong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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International St. Mary's Hospital

Incheon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hye-Won Jeong, master degree

Role: CONTACT

821025319131

Facility Contacts

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Hye-Won Jeong, Master's degree

Role: primary

821025319131

Other Identifiers

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CatholicKU

Identifier Type: -

Identifier Source: org_study_id

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