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Acupuncture for Postoperative Pain in Wrist Fractures

N/A
Recruiting
Led By Jaime Ortiz, MD, MBA
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
Patients scheduled to undergo distal radius ORIF under brachial plexus nerve block
American Society of Anesthesiologists Physical Status 1, 2, or 3
Must not have
Renal dysfunction (Serum Cr > 1.2) - excluded due to potential for altered metabolism of anesthetic and perioperative medications
Patient inability to properly communicate with investigators
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if acupuncture can reduce post-surgery opioid use for wrist fractures.

Who is the study for?
This trial is for adults aged 18-64 who are in good to moderate health (ASA Physical Status 1, 2, or 3) and scheduled for surgery to fix a broken bone near the wrist under nerve block anesthesia. It's not for those with kidney issues, allergies to anesthetic agents, or communication difficulties.
What is being tested?
The study is testing if ear acupuncture during surgery can reduce the need for painkillers after wrist fracture repair. Participants will be randomly assigned to receive either acupuncture or no acupuncture as part of their pain management plan.
What are the potential side effects?
While acupuncture is generally considered safe, potential side effects may include minor bleeding or bruising at needle sites, dizziness, fainting, and rarely infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for wrist surgery with a specific type of anesthesia.
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My health is good to moderately impaired according to anesthesia guidelines.
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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is normal.
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I cannot effectively communicate with my healthcare team.

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

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811
2%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List

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
Acupuncture
2011
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,022 Previous Clinical Trials
6,029,280 Total Patients Enrolled
4 Trials studying Postoperative Pain
336 Patients Enrolled for Postoperative Pain
Jaime Ortiz, MD, MBAPrincipal InvestigatorBaylor College of Medicine
~67 spots leftby Dec 2025
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