Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

Study Overview
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Brief Summary
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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.

Official Title
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Auricular Acupuncture As Part Of A Multimodal Analgesic Regimen For Reduction Of Opioid Analgesic Use After Surgery To Repair Lower Leg Fractures- A Randomized Controlled Trial

Conditions
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Pain, Postoperative, Fracture, Ankle, Pilon Fracture of Tibia, Foot Fracture

Intervention / Treatment
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* Device: Auricular acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ages 18-64 American Society of Anesthesiology Physical Status I, II or III Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital Exclusion Criteria: Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications Allergy to any of the standard anesthetic agents Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) Patient or surgeon refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroauricular acupuncture<br>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: Auricular acupuncture<br>* Electro auricular acupuncture<br>|
| No Intervention: No acupuncture<br>No acupuncture treatment given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 14 days |