An interventional study of Acupuncture in Radius Fracture Distal and Pain, Postoperative, sponsored by Baylor College of Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
This randomized controlled trial will test the hypothesis that patients receiving an intraoperative auricular acupuncture protocol will require less postoperative opioid analgesic use compared to those who do not receive acupuncture in the setting of a multimodal analgesic protocol for patients receiving surgery to repair distal radius fractures at a Level 1 trauma center under brachial plexus anesthesia with sedation.
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Exclusion Criteria:
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.
Device: Acupuncture
No acupuncture treatment given
Electroacupuncture
Total opioid analgesic use for 14 days after surgery
Total opioid given in hospital and taken at home, converted to oral morphine equivalents
Time frame: 14 days
Pain scores
Pain scores in PACU and at the 7 and 14 day mark post surgery
Time frame: 14 days
Incidence of side effects associated with opioid use
PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine