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

NCT ID: NCT03114449

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

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

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Auricular acupuncture

Auricular acupuncture (AA) with indwelling fixed needles at specific AA points

Group Type: EXPERIMENTAL

Auricular acupuncture

Intervention Type: DEVICE

Auricular acupuncture with indwelling fixed needles at specific AA points

Sham auricular acupuncture

Sham auricular acupuncture with indwelling fixed needles at non- AA points

Group Type: SHAM_COMPARATOR

Sham auricular acupuncture

Intervention Type: DEVICE

Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points

Interventions

Auricular acupuncture

Auricular acupuncture with indwelling fixed needles at specific AA points

Intervention Type: DEVICE

Sham auricular acupuncture

Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Naemi-Wilke-Stift Guben Hospital - Anesthesia Services

OTHER

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BB 102/11

Identifier Type: -

Identifier Source: org_study_id