Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty (AA_K-TEP)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auricular acupuncture
Sham auricular acupuncture
Sponsored by
![University Medicine Greifswald](https://trials-media.s3.amazonaws.com/orgs/university-medicine-greifswald.jpeg)
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Auricular acupuncture
Sham auricular acupuncture
Arm Description
Auricular acupuncture (AA) with indwelling fixed needles at specific AA points
Sham auricular acupuncture with indwelling fixed needles at non- AA points
Outcomes
Primary Outcome Measures
Postoperative requirement of analgesic tilidine (measured in mg)
Requirement of opioid analgesic tilidin
Secondary Outcome Measures
Side effects of analgesics
Incidence of nausea and vomiting
heart rate
heart rate
blood pressure
blood pressure
Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)
Full Information
NCT ID
NCT03114449
First Posted
April 3, 2017
Last Updated
April 10, 2017
Sponsor
University Medicine Greifswald
Collaborators
Naemi-Wilke-Stift Guben Hospital - Anesthesia Services
1. Study Identification
Unique Protocol Identification Number
NCT03114449
Brief Title
Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty
Acronym
AA_K-TEP
Official Title
Auricular Acupuncture (AA) vs. Sham AA Procedure for Pain Control After Elective Knee Arthroplasty - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
Collaborators
Naemi-Wilke-Stift Guben Hospital - Anesthesia Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular acupuncture
Arm Type
Experimental
Arm Description
Auricular acupuncture (AA) with indwelling fixed needles at specific AA points
Arm Title
Sham auricular acupuncture
Arm Type
Sham Comparator
Arm Description
Sham auricular acupuncture with indwelling fixed needles at non- AA points
Intervention Type
Device
Intervention Name(s)
Auricular acupuncture
Intervention Description
Auricular acupuncture with indwelling fixed needles at specific AA points
Intervention Type
Device
Intervention Name(s)
Sham auricular acupuncture
Intervention Description
Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points
Primary Outcome Measure Information:
Title
Postoperative requirement of analgesic tilidine (measured in mg)
Description
Requirement of opioid analgesic tilidin
Time Frame
Six days following surgery
Secondary Outcome Measure Information:
Title
Side effects of analgesics
Description
Incidence of nausea and vomiting
Time Frame
Six days following surgery
Title
heart rate
Description
heart rate
Time Frame
12 hours after surgery
Title
blood pressure
Description
blood pressure
Time Frame
12 hours following surgery
Title
Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)
Time Frame
12 hours following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty
We'll reach out to this number within 24 hrs