Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

• ClinicalTrials.gov Identifier: NCT05984433
• Recruitment Status: Recruiting
• First Posted: August 9, 2023
• Last Update Posted: October 11, 2023
• Sponsor: Baylor College of Medicine
• Information provided by (Responsible Party): Jaime Ortiz, Baylor College of Medicine

Tracking Information

• First Submitted Date: July 26, 2023
• First Posted Date: August 9, 2023
• Last Update Posted Date: October 11, 2023
• Actual Study Start Date: October 9, 2023
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 2, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 2, 2023)

• Pain scores [ Time Frame: 14 days ]
  Pain scores (1-10) in PACU and at the 7 and 14 day mark post surgery
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Pain, Postoperative
• Fracture, Ankle
• Pilon Fracture of Tibia
• Foot Fracture

Intervention

Device: Auricular acupuncture

Electro auricular acupuncture

Study Arms

• 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.
  Intervention: Device: Auricular acupuncture
• No Intervention: No acupuncture
  No acupuncture treatment given

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 2, 2023): 140
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05984433
• Other Study ID Numbers: H-53820
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jaime Ortiz, Baylor College of Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Baylor College of Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Baylor College of Medicine
• Verification Date: October 2023