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

Auricular Acupuncture As Part Of A Multimodal Regimen For Reduction Of Opioid Analgesic Use After Distal Radius Open Reduction and Internal Fixation- A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative; Radius Fracture Distal
• Intervention / Treatment: Device: Acupuncture

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Acupuncture; Electroacupuncture
No Intervention: No acupuncture; No acupuncture treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain scores in PACU and at the 7 and 14 day mark post surgery	14 days
Incidence of side effects associated with opioid use	PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth	14 days

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Jaime Ortiz, MD, MBA, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): October 9, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Fractures, Bone; Arm Injuries; Wrist Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wrist Fractures; Pain, Postoperative; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: H-53875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No