Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation

Baylor College of Medicine

Status: Enrolling

Conditions: Pain, Postoperative; Radius Fracture Distal

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05974254

H-53875

Details and patient eligibility

About

This randomized controlled trial will test the hypothesis that patients receiving an intraoperative auricular acupuncture protocol will require less postoperative opioid analgesic use compared to those who do not receive acupuncture in the setting of a multimodal analgesic protocol for patients receiving surgery to repair distal radius fractures at a Level 1 trauma center under brachial plexus anesthesia with sedation.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ages 18-64
• American Society of Anesthesiologists Physical Status 1, 2, or 3
• Patients scheduled to undergo distal radius ORIF under brachial plexus nerve block

Exclusion criteria

• Renal dysfunction (Serum Cr > 1.2) - excluded due to potential for altered metabolism of anesthetic and perioperative medications
• Allergy to any of the standard anesthetic agents
• Patient inability to properly communicate with investigators
• Patient or surgeon refusal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Electroauricular acupuncture

Experimental group

Description:

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.

Treatment:

Device: Acupuncture

No acupuncture

No Intervention group

Description:

No acupuncture treatment given