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Unable to support start of study. PI left institution
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The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.
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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 |
|---|---|---|---|---|
| Auricular acupuncture | Device | Electro auricular acupuncture |
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| 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 (1-10) 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group
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The patient will be under sedation during procedure, so will not be aware of whether or not they received acupuncture treatment.
Anesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of group assignment
| 14 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |