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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04056585
Other study ID # CatholicKU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2019
Est. completion date October 15, 2020

Study information

Verified date August 2019
Source Catholic Kwandong University
Contact Hye-Won Jeong, master degree
Phone 821025319131
Email jklm110303@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date October 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound guided axillary plexus block
Ultrasound guided axillary plexus block with 1.5% mepivacaine 30 ml
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.

Locations

Country Name City State
Korea, Republic of International St. Mary's Hospital Incheon

Sponsors (1)

Lead Sponsor Collaborator
Catholic Kwandong University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time to achieve surgical anaesthesia Defined as the time to reach an absent sensation in the pinprick test and reduced power at all four nerve distributions (ulnar nerve, radial nerve, median nerve, and musculocutaneous nerve) 1 hour
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