Acupuncture for Postoperative Pain in Wrist Fractures

Overseen By Jaime Ortiz, MD, MBA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Renal dysfunction, Allergy, Communication issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

140 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

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. ^{1 2 3 5 8}

Research Team

Jaime Ortiz, MD, MBA

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Electroauricular acupuncture Experimental Treatment 1 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 acupuncture Active Control 1 Intervention

No acupuncture treatment given

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials. Usichenko, TI., Lehmann, Ch., Ernst, E.[2018]

Auricular acupuncture significantly reduced postoperative pain levels in patients undergoing total hip arthroplasty, as indicated by lower VAS scores compared to the control group over several days post-surgery.

Patients receiving auricular acupuncture required less analgesic medication and experienced fewer complications, such as nausea and vomiting, while also showing improved hip joint function two weeks after the operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Case-control study on application of auricular acupuncture for the treatment of analgesia during perioperative period in total hip arthroplasty]. Wang, JF., Bao, HX., Cai, YH., et al.[2012]

Auricular acupuncture (AA) significantly reduced the need for post-operative analgesics, with patients in the AA group consuming a median of 500 mg of ibuprofen compared to 800 mg in the control group, indicating its potential effectiveness in pain management after knee surgery.

While AA did not show a difference in pain intensity or other recovery parameters between the groups, it suggests that AA could be a beneficial adjunct therapy to lower analgesic requirements following ambulatory knee arthroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular Acupuncture for Pain Relief after Ambulatory Knee Arthroscopy-A Pilot Study. Usichenko, TI., Hermsen, M., Witstruck, T., et al.[2020]

A systematic review of various studies found that adverse events from auricular therapy (AT) are generally mild and transient, with common issues including tenderness, dizziness, and local discomfort, but no serious adverse events were reported.

The study highlights the need for improved reporting of adverse events in future AT research, suggesting that while AT appears to be a safe treatment option, more comprehensive data collection is necessary to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. Tan, JY., Molassiotis, A., Wang, T., et al.[2022]

Auricular acupuncture (AA) is generally safe, but this case report highlights a rare occurrence where an Aiguille Semi-Permanente® (ASP®) needle was found retained in a patient's external auditory canal after treatment for complex regional pain syndrome.

Acupuncturists should be vigilant for potential complications, such as a foreign-body sensation in the ear, and conduct examinations if patients report unusual symptoms following AA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. Kazal, LA.[2023]

In a study of 72 patients undergoing laparotomy for gynecological diseases, combined electroacupuncture and auricular acupuncture significantly reduced pain at rest compared to a sham control, particularly at 22 hours post-surgery.

While the acupuncture group reported lower pain scores, the overall efficacy of acupuncture for postoperative pain management remains inconclusive, as no significant differences were found in other outcomes and no serious adverse events occurred.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combination of electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynaecological diseases: A randomized controlled trial. Lam, WL., Wang, J., Yeung, WF., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Case-control study on application of auricular acupuncture for the treatment of analgesia during perioperative period in total hip arthroplasty]. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Auricular Acupuncture for Pain Relief after Ambulatory Knee Arthroscopy-A Pilot Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

A combination of electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynaecological diseases: A randomized controlled trial. [2022]