Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation
NCT ID: NCT05974254
Last Updated: 2025-01-14
Study Results
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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RECRUITING
NA
140 participants
INTERVENTIONAL
2023-10-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The PACU team and outcomes assessor will not be aware of patient group assignment.
Study Groups
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Electroauricular acupuncture
Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.
Acupuncture
Electroacupuncture
No acupuncture
No acupuncture treatment given
No interventions assigned to this group
Interventions
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Acupuncture
Electroacupuncture
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists Physical Status 1, 2, or 3
* Patients scheduled to undergo distal radius ORIF under brachial plexus nerve block
Exclusion Criteria
* Allergy to any of the standard anesthetic agents
* Patient inability to properly communicate with investigators
* Patient or surgeon refusal
18 Years
64 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Jaime Ortiz
Professor of Anesthesiology
Principal Investigators
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Jaime Ortiz, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Ben Taub Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-53875
Identifier Type: -
Identifier Source: org_study_id
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