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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study Summary

This trial will see if acupuncture helps reduce opioid use after surgery to fix a broken leg.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total opioid analgesic use for 14 days after surgery

Secondary outcome measures

Incidence of side effects associated with opioid use

Pain scores

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

~1030

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,272 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor include participants aged 60 and above?

"Potential participants must fulfill certain criteria to be considered for this research, including being between 18 and 64 years of age. There are 131 studies involving persons younger than 18 and 726 trials with elderly subjects aged 65 or above."

Answered by AI

How many participants is the clinical trial currently accommodating?

"Affirmative. According to clinicaltrials.gov, this trial is currently recruiting participants and has been since the 9th of October 2023. The study requires 140 volunteers from a single medical centre."

Answered by AI

What are the criteria for individuals to be eligible to participate in this clinical trial?

"Potential participants of this study must have sustained a pilon fracture and fall within the ages of 18-64. 140 individuals are required to fulfill the needs of this clinical trial."

Answered by AI

Is the trial still in its recruitment phase?

"That is correct. According to the clinicaltrials.gov data, this medical trial which was first uploaded on October 9th 2023 remains active and actively recruiting patients from a single site with an aim of collecting 140 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

Jaime Ortiz 2023. "Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05984433.