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

Postoperative Pain Clinical Trial

— AA_K-TEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114449
• Other study ID #: BB 102/11
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: April 10, 2017
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2017
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Auricular acupuncture
Auricular acupuncture with indwelling fixed needles at specific AA points
• Sham auricular acupuncture
Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	Abteilung Anästhesie, Niemi-Wilke-Stift, Guben

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative requirement of analgesic tilidine (measured in mg)	Requirement of opioid analgesic tilidin	Six days following surgery
Secondary	Side effects of analgesics	Incidence of nausea and vomiting	Six days following surgery
Secondary	heart rate	heart rate	12 hours after surgery
Secondary	blood pressure	blood pressure	12 hours following surgery
Secondary	Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)		12 hours following surgery