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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Device: Auricular acupuncture; Device: Sham auricular acupuncture

• Registration Number: NCT03114449
• Lead Sponsor: University Medicine Greifswald

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2017-04
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Study First Posted: 2017-04-14
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective knee arthroplasty under general anesthesia
2. Surgery time does not exceed 120 minutes
3. Patients without previous opioid medication
4. Patients ranged 50-80 years old
5. Patients who have given written informed consent

Exclusion Criteria

1. Recidivist alcoholics
2. Local auricular skin infection
3. Age < 50 and > 80 years
4. Surgery time more than 120 minutes
5. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
6. Patients who consumed opioid medication at least 6 months before surgery
7. 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)
8. Patients who are unable to understand the consent form
9. History of psychiatric disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular acupuncture	Auricular acupuncture	Auricular acupuncture (AA) with indwelling fixed needles at specific AA points
Sham auricular acupuncture	Sham auricular acupuncture	Sham auricular acupuncture with indwelling fixed needles at non- AA points

Primary Outcome Measures

Name	Time	Method
Postoperative requirement of analgesic tilidine (measured in mg)	Six days following surgery	Requirement of opioid analgesic tilidin

Secondary Outcome Measures

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