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

• ClinicalTrials.gov Identifier: NCT05974254
• Recruitment Status: Recruiting
• First Posted: August 3, 2023
• Last Update Posted: October 11, 2023
• Sponsor: Baylor College of Medicine
• Information provided by (Responsible Party): Jaime Ortiz, Baylor College of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Radius Fracture Distal; Pain, Postoperative	Device: Acupuncture	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial Group 1 - acupuncture treatment Group 2 - no acupuncture treatment 70 patients per group
• Masking: Double (Participant, Outcomes Assessor)

Masking Description

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.

• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 9, 2023
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Total opioid analgesic use for 14 days after surgery [ Time Frame: 14 days ]
   Total opioid given in hospital and taken at home, converted to oral morphine equivalents

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Jaime Ortiz, MD, MBA; 713-873-2860; jaimeo@bcm.edu

Locations

United States, Texas

Ben Taub Hospital; Recruiting

Houston, Texas, United States, 77030

Contact: Jaime Ortiz, MD,MBA 713-873-2860 jaimeo@bcm.edu

Principal Investigator: Jaime Ortiz, MD, MBA

Sponsors and Collaborators

Baylor College of Medicine

Investigators

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

More Information

• Responsible Party: Jaime Ortiz, Professor of Anesthesiology, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT05974254
• Other Study ID Numbers: H-53875
• First Posted: August 3, 2023
• Last Update Posted: October 11, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Pain, Postoperative; Radius Fractures; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone