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Unable to support start of study. PI left the institution. No patients recruited.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroauricular acupuncture | Experimental | 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. |
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| No acupuncture | No Intervention | No acupuncture treatment given |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | Electroacupuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid analgesic use for 14 days after surgery | Total opioid given in hospital and taken at home, converted to oral morphine equivalents | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Pain scores in PACU and at the 7 and 14 day mark post surgery | 14 days |
| Incidence of side effects associated with opioid use | PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Ortiz, MD, MBA | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Randomized controlled trial Group 1 - acupuncture treatment Group 2 - no acupuncture treatment 70 patients per group
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The patients will be under sedation in the operating room and will not be aware of which treatment group they are in.
The PACU team and outcomes assessor will not be aware of patient group assignment.
| 14 days |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |