140 Participants Needed

Acupuncture for Postoperative Pain in Wrist Fractures

JO
Overseen ByJaime Ortiz, MD, MBA
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Baylor College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is auricular acupuncture safe for humans?

Auricular acupuncture is generally considered safe for humans, with most reported side effects being mild and temporary, such as tenderness, dizziness, and minor bleeding. No serious adverse events have been identified in the studies reviewed.12345

How does acupuncture differ from other treatments for postoperative pain in wrist fractures?

Acupuncture is unique because it involves inserting thin needles into specific points on the body to relieve pain, unlike traditional pain medications that are taken orally or intravenously. It is a non-drug approach that may reduce the need for pain medications and their potential side effects.25678

What data supports the effectiveness of the treatment Auricular Acupuncture for reducing postoperative pain in wrist fractures?

Research shows that auricular acupuncture can reduce the need for pain medication after surgeries like hip and knee operations, suggesting it might also help with pain after wrist fracture surgery.24567

Who Is on the Research Team?

JO

Jaime Ortiz, MD, MBA

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for wrist surgery with a specific type of anesthesia.
My health is good to moderately impaired according to anesthesia guidelines.

Exclusion Criteria

My kidney function is normal.
I cannot effectively communicate with my healthcare team.
I or my surgeon have decided against a specific treatment.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative auricular acupuncture or no acupuncture during surgery for distal radius fractures

1 day
1 visit (in-person)

Postoperative Monitoring

Participants' opioid analgesic use and side effects are monitored for 14 days after surgery

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Auricular Acupuncture
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Electroauricular acupunctureExperimental Treatment1 Intervention
Group II: No acupunctureActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

Published Research Related to This Trial

In a study involving 120 patients undergoing total hip arthroplasty, those receiving auricular acupuncture (AA) required 15% less fentanyl for pain management during surgery compared to a sham group, indicating a potential analgesic effect of AA.
The study suggests that while AA may provide modest pain relief, further research is needed to fully understand its effectiveness as a complementary analgesic method in surgical settings.
The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial.Wetzel, B., Pavlovic, D., Kuse, R., et al.[2022]
Auricular acupuncture (AA) significantly reduced the need for postoperative pain medication (piritramide) in patients after total hip arthroplasty, with the AA group requiring an average of 37 mg compared to 54 mg in the control group.
The study involved 54 patients and showed that while AA effectively lowered analgesic requirements, pain intensity and side effects were similar between the AA and sham acupuncture groups, suggesting AA can be a complementary approach for pain management.
Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study.Usichenko, TI., Dinse, M., Hermsen, M., et al.[2022]
A review of 23 studies on auricular acupuncture for postoperative pain found that 9 met the criteria for inclusion, with 8 showing that auricular acupuncture was more effective than control conditions.
While the evidence suggests that auricular acupuncture can help reduce postoperative pain, the overall findings are not strong enough to be considered definitive, as the studies varied widely in quality and results.
Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials.Usichenko, TI., Lehmann, Ch., Ernst, E.[2018]

Citations

The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial. [2022]
Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. [2022]
Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials. [2018]
[Case-control study on application of auricular acupuncture for the treatment of analgesia during perioperative period in total hip arthroplasty]. [2012]
Auricular Acupuncture for Pain Relief after Ambulatory Knee Arthroscopy-A Pilot Study. [2020]
Adverse events of auricular therapy: a systematic review. [2022]
Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. [2023]
A combination of electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynaecological diseases: A randomized controlled trial. [2022]
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