Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty (AA_K-TEP)

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Auricular acupuncture; Device: Sham auricular acupuncture

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: Naemi-Wilke-Stift Guben Hospital - Anesthesia Services

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: BB 102/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No