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

Primary Purpose

Forearm Injuries, Hand Injuries

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ultrasound guided axillary plexus block

Intermittent pneumatic compression maneuver

About this trial

This is an interventional treatment trial for Forearm Injuries focused on measuring brachial plexus block, intermittent pneumatic compression maneuver

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

International St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brachial plexus block with intermittent pneumatic compression

Brachial plexus block

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT04056585

First Posted

August 9, 2019

Last Updated

August 13, 2019

Sponsor

Catholic Kwandong University

1. Study Identification

Unique Protocol Identification Number

NCT04056585

Brief Title

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

Official Title

Intermittent Pneumatic Compression May Reduce Brachial Plexus Block Onset Time

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

July 15, 2020 (Anticipated)

Study Completion Date

October 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catholic Kwandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Forearm Injuries, Hand Injuries

Keywords

brachial plexus block, intermittent pneumatic compression maneuver

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Brachial plexus block with intermittent pneumatic compression

Arm Type

Experimental

Arm Description

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

Arm Title

Brachial plexus block

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Ultrasound guided axillary plexus block

Intervention Description

Ultrasound guided axillary plexus block with 1.5% mepivacaine 30 ml

Intervention Type

Procedure

Intervention Name(s)

Intermittent pneumatic compression maneuver

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to achieve complete sensory block

Description

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)

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Time to achieve surgical anaesthesia

Description

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)

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hye-Won Jeong, master degree

Phone

821025319131

jklm110303@gmail.com

Facility Information:

Facility Name

International St. Mary's Hospital

City

Incheon

ZIP/Postal Code

22711

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hye-Won Jeong, Master's degree

Phone

821025319131

jklm110303@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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