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Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05984433
Recruitment Status : Recruiting
First Posted : August 9, 2023
Last Update Posted : October 11, 2023
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Fracture, Ankle Pilon Fracture of Tibia Foot Fracture Device: Auricular acupuncture Not Applicable

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

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
Primary Purpose: Treatment
Official Title: Auricular Acupuncture As Part Of A Multimodal Analgesic Regimen For Reduction Of Opioid Analgesic Use After Surgery To Repair Lower Leg Fractures- A Randomized Controlled Trial
Actual Study Start Date : October 9, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Auricular acupuncture
Electro auricular acupuncture
No Intervention: No acupuncture
No acupuncture treatment given


Outcome Measures
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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 (1-10) 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
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient ages 18-64
  2. American Society of Anesthesiology Physical Status I, II or III
  3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital

Exclusion Criteria:

  1. Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
  2. Allergy to any of the standard anesthetic agents
  3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
  4. Patient or surgeon refusal
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984433


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

Locations
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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
More Information
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Responsible Party: Jaime Ortiz, Professor of Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05984433    
Other Study ID Numbers: H-53820
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: October 11, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pain, Postoperative
Fractures, Bone
Tibial Fractures
Ankle Fractures
Wounds and Injuries
Postoperative Complications
 Pathologic Processes
Pain
Neurologic Manifestations
Leg Injuries
Ankle Injuries