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

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

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05974254

Enrollment

Registered

2023-08-03

Start date

2023-10-09

Completion date

2025-12-01

Last updated

2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Radius Fracture Distal

Brief 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.

Interventions

DEVICEAcupuncture

Electroacupuncture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

The patients will be under sedation in the operating room and will not be aware of which treatment group they are in. The PACU team and outcomes assessor will not be aware of patient group assignment.

Intervention model description

Randomized controlled trial Group 1 - acupuncture treatment Group 2 - no acupuncture treatment 70 patients per group

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Total opioid analgesic use for 14 days after surgery	14 days	Total opioid given in hospital and taken at home, converted to oral morphine equivalents

Secondary

Measure	Time frame	Description
Pain scores	14 days	Pain scores in PACU and at the 7 and 14 day mark post surgery
Incidence of side effects associated with opioid use	14 days	PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJaime Ortiz, MD, MBA

Baylor College of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026