Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation

Pain, Postoperative Clinical Trial

Official title:

Auricular Acupuncture As Part Of A Multimodal Regimen For Reduction Of Opioid Analgesic Use After Distal Radius Open Reduction and Internal Fixation- A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974254
• Other study ID #: H-53875
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• 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

This randomized controlled trial will test the hypothesis that patients receiving an intraoperative auricular acupuncture protocol will require less postoperative opioid analgesic use compared to those who do not receive acupuncture in the setting of a multimodal analgesic protocol for patients receiving surgery to repair distal radius fractures at a Level 1 trauma center under brachial plexus anesthesia with sedation.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Patient ages 18-64
• American Society of Anesthesiologists Physical Status 1, 2, or 3
• Patients scheduled to undergo distal radius ORIF under brachial plexus nerve block

Exclusion Criteria:

• Renal dysfunction (Serum Cr > 1.2) - excluded due to potential for altered metabolism of anesthetic and perioperative medications
• Allergy to any of the standard anesthetic agents
• Patient inability to properly communicate with investigators
• Patient or surgeon refusal

Related Conditions & MeSH terms

• Pain, Postoperative
• Radius Fracture Distal
• Radius Fractures

Intervention

Device:
• Acupuncture
Electroacupuncture

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 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