Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty

Study Overview
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Brief Summary
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Aim of the study To investigate whether auricular acupuncture (AA) will reduce postoperative pain and analgesic requirement in comparison with sham AA in patients after elective knee arthroplasty Design Prospective randomized controlled blinded clinical trial Participants: Patients < 80 und > 50 years old scheduled for knee arthroplasty under general anesthesia with < 120 minutes duration Without previous opioid medication Able to give informed consent Outcome measures Postoperative analgesic requirement Incidence of side effects Physiological parameters

Official Title
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Auricular Acupuncture (AA) vs. Sham AA Procedure for Pain Control After Elective Knee Arthroplasty - a Randomized Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: Auricular acupuncture
* Device: Sham auricular acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective knee arthroplasty under general anesthesia Surgery time does not exceed 120 minutes Patients without previous opioid medication Patients ranged 50-80 years old Patients who have given written informed consent Exclusion Criteria: Recidivist alcoholics Local auricular skin infection Age < 50 and > 80 years Surgery time more than 120 minutes Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines) Patients who consumed opioid medication at least 6 months before surgery Patients with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA) Patients who are unable to understand the consent form History of psychiatric disease

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular acupuncture<br>Auricular acupuncture (AA) with indwelling fixed needles at specific AA points | Device: Auricular acupuncture<br>* Auricular acupuncture with indwelling fixed needles at specific AA points<br>|
| Sham Comparator: Sham auricular acupuncture<br>Sham auricular acupuncture with indwelling fixed needles at non- AA points | Device: Sham auricular acupuncture<br>* Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative requirement of analgesic tilidine (measured in mg) | Requirement of opioid analgesic tilidin | Six days following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of analgesics | Incidence of nausea and vomiting | Six days following surgery | 
| heart rate | heart rate | 12 hours after surgery | 
| blood pressure | blood pressure | 12 hours following surgery | 
| Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad) |  | 12 hours following surgery |