Using auricular acupuncture to reduce pain after lower leg surgery

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

This study tests if adding auricular acupuncture during lower leg surgery can help patients manage pain better and use fewer opioid medications afterward.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Baylor College of Medicine (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05984433 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of incorporating intraoperative electro auricular acupuncture into a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fractures. The goal is to determine if this approach can reduce the need for postoperative opioid medications. Patients will be monitored for pain levels and opioid consumption following their surgery. The study focuses on individuals undergoing ankle open reduction and internal fixation (ORIF) at a specific hospital.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 who are scheduled for ankle ORIF surgery and have an American Society of Anesthesiology Physical Status of I, II, or III.

Not a fit: Patients with renal dysfunction, allergies to anesthetic agents, or communication barriers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced opioid use and improved pain management for patients after lower leg surgery.

How similar studies have performed: While the use of acupuncture in pain management has been explored, this specific approach combining auricular acupuncture with multimodal analgesia is relatively novel.

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

Where this trial is running

Houston, Texas

• Ben Taub Hospital — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Jaime Ortiz, MD, MBA

Conditions: Pain, Postoperative, Fracture, Ankle, Pilon Fracture of Tibia, Foot Fracture