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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05984433
Other study ID # H-53820
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 9, 2023
Est. completion date December 2025

Study information

Verified date May 2024
Source Baylor College of Medicine
Contact Jaime Ortiz, MD, MBA
Phone 713-873-2860
Email jaimeo@bcm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Intervention

Device:
Auricular acupuncture
Electro auricular acupuncture

Locations

Country Name City State
United States Ben Taub Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain scores Pain scores (1-10) in PACU and at the 7 and 14 day mark post surgery 14 days
Secondary Incidence of side effects associated with opioid use PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth 14 days
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