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

University Medicine Greifswald0 sites150 target enrollmentOctober 2012

ConditionsPostoperative Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postoperative Pain
Sponsor: University Medicine Greifswald
Enrollment: 150
Primary Endpoint: Postoperative requirement of analgesic tilidine (measured in mg)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

December 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Medicine Greifswald

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Postoperative requirement of analgesic tilidine (measured in mg)

Time Frame: Six days following surgery

Requirement of opioid analgesic tilidin

Secondary Outcomes

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)
Side effects of analgesics(Six days following surgery)
heart rate(12 hours after surgery)