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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05974254
Other study ID # H-53875
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 October 2023
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

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

Study Design


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
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