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Auricular Acupuncture for Postoperative Pain After Lower Leg Fracture

N/A
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient ages 18-64
American Society of Anesthesiology Physical Status I, II or III
Must not have
Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether using electrical acupuncture on the ear can help reduce the need for strong painkillers for patients having surgery for lower leg fractures with spinal anesthesia. The idea is that this method might help manage pain better, so fewer opioids are needed. Electroacupuncture has been shown to reduce pain and the need for pain relief in various surgical settings.

Who is the study for?
This trial is for adults aged 18-64 who are in good to moderate health and scheduled for ankle surgery at Ben Taub Hospital. They must be able to communicate clearly with researchers. People with kidney issues, allergies to anesthesia, or communication barriers due to language or mental health conditions cannot participate.
What is being tested?
The study is testing if auricular acupuncture can reduce the need for opioid painkillers after lower leg surgery when added to standard pain management practices. Patients will receive this treatment during their operation under spinal anesthesia.
What are the potential side effects?
Auricular acupuncture may cause minor side effects such as local discomfort, bleeding, infection at the needle sites, dizziness or nausea. However, it's generally considered safe and these events are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 64 years old.
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My overall health is good to moderately impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can communicate clearly without any major issues.
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My kidney function is normal, with a creatinine level at or below 1.2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total opioid analgesic use for 14 days after surgery
Secondary study objectives
Incidence of side effects associated with opioid use
Pain scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Electroauricular acupunctureExperimental Treatment1 Intervention
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.
Group II: No acupunctureActive Control1 Intervention
No acupuncture treatment given
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auricular acupuncture
2013
Completed Phase 3
~1090

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for foot fractures include immobilization, surgical intervention, and pain management strategies such as medications and physical therapy. Intraoperative electro auricular acupuncture, a technique being studied for its potential benefits, works by modulating pain pathways and reducing pain perception through electrical stimulation of specific auricular points. This method can help decrease postoperative opioid use, which is crucial for minimizing the risk of addiction and side effects. For foot fracture patients, effective pain management is essential for promoting healing, improving mobility, and enhancing overall quality of life.
Electroacupuncture For Alleviation Of Phantom Limb Pain.[Clinical observation on common peroneal nerve palsy treated with comprehensive therapy].

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Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,022 Previous Clinical Trials
6,029,177 Total Patients Enrolled
~56 spots leftby Jul 2025
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