Pain, Postoperative Clinical Trial
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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Ben Taub Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
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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