Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

Not Applicable

Recruiting

• Conditions: Pain, Postoperative; Fracture, Ankle; Pilon Fracture of Tibia; Foot Fracture
• Interventions: Device: Auricular acupuncture

• Registration Number: NCT05984433
• Lead Sponsor: Baylor College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-09
• Study Start: 2024-10-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital

Exclusion Criteria

1. Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
2. Allergy to any of the standard anesthetic agents
3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
4. Patient or surgeon refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroauricular acupuncture	Auricular 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.

Primary Outcome Measures

Name	Time	Method
Total opioid analgesic use for 14 days after surgery	14 days	Total opioid given in hospital and taken at home, converted to oral morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects associated with opioid use	14 days	PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth
Pain scores	14 days	Pain scores (1-10) in PACU and at the 7 and 14 day mark post surgery

Trial Locations

Locations (1)

Ben Taub Hospital; 🇺🇸 Houston, Texas, United States