Forearm InjuriesNCT04056585
Intermittent Compression Maneuver of Upper Arm to Reduce Axillary Brachial Plexus Block Onset Time
A study testing Ultrasound guided axillary plexus block and Intermittent pneumatic compression maneuver in people with Forearm Injuries and Hand Injuries, run by Catholic Kwandong University at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Forearm Injuries, Hand Injuries
- What is being tested?
- Ultrasound guided axillary plexus block and Intermittent pneumatic compression maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jul 2019to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
International St. Mary's Hospital
Incheon, 22711
Hye-Won Jeong, Master's degree, 821025319131, jklm110303@gmail.com
About this study
Official title: Intermittent Pneumatic Compression May Reduce Brachial Plexus Block Onset Time
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.
- Conditions
- Forearm Injuries, Hand Injuries
- Being tested
- Ultrasound guided axillary plexus block, Intermittent pneumatic compression maneuver
- Keywords
- brachial plexus block, intermittent pneumatic compression maneuver
- Medical subject headings
- Forearm Injuries, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided axillary plexus blockProcedure or surgery
Ultrasound guided axillary plexus block with 1.5% mepivacaine 30 ml
Intermittent pneumatic compression maneuverProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Brachial plexus block with intermittent pneumatic compression | Experimental | Hand and forearm surgery is performed after axillary brachial plexus block with intermittent pneumatic compression for 3 minutes. Receives: Procedure: Ultrasound guided axillary plexus block; Procedure: Intermittent pneumatic compression maneuver |
| Brachial plexus block | Placebo comparator | Hand and forearm surgery is performed after axillary brachial plexus block only. Receives: Procedure: Ultrasound guided axillary plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour
Secondary outcomes (1)
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)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start15 Jul 2019
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic Kwandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye-Won Jeong, Catholic Kwandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056585
- Sponsor's protocol ID
- CatholicKU
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Pneumatic Compression May Reduce Brachial Plexus Block Onset Time
- ClinicalTrials.gov ID
- NCT04056585
- Acronym / sponsor ID
- CatholicKU
- Conditions
- Forearm Injuries, Hand Injuries
- Keywords
- brachial plexus block, intermittent pneumatic compression maneuver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Catholic Kwandong UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brachial plexus block with intermittent pneumatic compression | Experimental | Procedure: Ultrasound guided axillary plexus block, Procedure: Intermittent pneumatic compression maneuverHand and forearm surgery is performed after axillary brachial plexus block with intermittent pneumatic compression for 3 minutes. |
| Brachial plexus block | Placebo comparator | Procedure: Ultrasound guided axillary plexus blockHand and forearm surgery is performed after axillary brachial plexus block only. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided axillary plexus blockUltrasound guided axillary plexus block with 1.5% mepivacaine 30 ml | Procedure or surgery | Brachial plexus block, Brachial plexus block with intermittent pneumatic compression |
| Intermittent pneumatic compression maneuverFollowing 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. | Procedure or surgery | Brachial plexus block with intermittent pneumatic compression |
Primary outcome
Time to achieve complete sensory block
Time frame: 1 hour
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 secondary outcome
Time to achieve surgical anaesthesia
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided axillary plexus block and Intermittent pneumatic compression maneuver in people with Forearm Injuries and Hand Injuries, run by Catholic Kwandong University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hye-Won Jeong, master degree (821025319131, jklm110303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve complete sensory block (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.