Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

Sponsor

Baylor College of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05984433

Collaborator

(none)

140

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Fracture, Ankle Pilon Fracture of Tibia Foot Fracture	Device: Auricular 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 Group 2 - no acupuncture 70 patients per groupRandomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The patient will be under sedation during procedure, so will not be aware of whether or not they received acupuncture treatment. Anesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of group assignment

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

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: Auricular acupuncture Electro auricular acupuncture
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: Auricular acupuncture

Electro auricular acupuncture

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 (1-10) 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 Anesthesiology Physical Status I, II or III
Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital

Exclusion Criteria:

Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
Allergy to any of the standard anesthetic agents
Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
Patient or surgeon refusal

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Baylor College of Medicine

Investigators

None specified.

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:

NCT05984433

Other Study ID Numbers:

H-53820

First Posted:

Aug 9, 2023

Last Update Posted:

Aug 9, 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:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2023