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
Overview
- Phase
- Not Applicable
- Intervention
- Auricular acupuncture
- Conditions
- Pain, Postoperative
- Sponsor
- Baylor College of Medicine
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Total opioid analgesic use for 14 days after surgery
- Status
- Withdrawn
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Investigators
Jaime Ortiz
Professor of Anesthesiology
Baylor College of Medicine
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Auricular acupuncture
No acupuncture
No acupuncture treatment given
Outcomes
Primary Outcomes
Total opioid analgesic use for 14 days after surgery
Time Frame: 14 days
Total opioid given in hospital and taken at home, converted to oral morphine equivalents
Secondary Outcomes
- Incidence of side effects associated with opioid use(14 days)
- Pain scores(14 days)