Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

NCT05984433 | Withdrawn FDA Device

• 1 other identifier: H-53820
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain scores

  14 days

• Incidence of side effects associated with opioid use

  14 days

Study Arms (2)

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.

Device: Auricular acupuncture

No acupuncture

NO INTERVENTION

No acupuncture treatment given

Interventions

Auricular acupuncture DEVICE

Electro auricular acupuncture

Electroauricular acupuncture

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Ankle Fractures

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 9, 2023
• Study Start: December 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)