Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture
NCT ID: NCT05984433
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
2024-10-09
2026-12-31
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
Anesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of 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.
Auricular acupuncture
Electro auricular acupuncture
No acupuncture
No acupuncture treatment given
No interventions assigned to this group
Interventions
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Auricular acupuncture
Electro auricular acupuncture
Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital
Exclusion Criteria
2. Allergy to any of the standard anesthetic agents
3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
4. 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
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-53820
Identifier Type: -
Identifier Source: org_study_id
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