Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984433
• Other study ID #: H-53820
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Ankle Fractures
• Foot Fracture
• Fracture, Ankle
• Fractures, Bone
• Pain, Postoperative
• Pilon Fracture of Tibia
• Tibial Fractures

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