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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05974254

Collaborator

(none)

140

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Fracture Distal Pain, Postoperative	Device: Acupuncture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, 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.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electroauricular acupuncture Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.	Device: Acupuncture Electroacupuncture
No Intervention: No acupuncture No acupuncture treatment given

Arm

Intervention/Treatment

Experimental: Electroauricular acupuncture

Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.

Device: Acupuncture

Electroacupuncture

No Intervention: No acupuncture

No acupuncture treatment given

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator: Jaime Ortiz, MD, MBA, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jaime Ortiz, Professor of Anesthesiology, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT05974254

Other Study ID Numbers:

H-53875

First Posted:

Aug 3, 2023

Last Update Posted:

Aug 4, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Radius Fractures

Study Results

No Results Posted as of Aug 4, 2023