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

NCT05974254 | Withdrawn FDA Device

• 1 other identifier: H-53875
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radius Fracture Distal; Pain, Postoperative

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: Acupuncture

No acupuncture

NO INTERVENTION

No acupuncture treatment given

Interventions

Acupuncture DEVICE

Electroacupuncture

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 Anesthesiologists Physical Status 1, 2, or 3
• Patients scheduled to undergo distal radius ORIF under brachial plexus nerve block

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Wrist Fractures; Pain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jaime Ortiz, MD, MBA

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients will be under sedation in the operating room and will not be aware of which treatment group they are in. The PACU team and outcomes assessor will not be aware of patient 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 treatment Group 2 - no acupuncture treatment 70 patients per group

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: October 9, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)