Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

Acute Pain Clinical Trial

Official title:

Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334165
• Other study ID #: III UV 13/05
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 3, 2006
• Last updated: February 25, 2011
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: February 2011
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective hip arthroplasty because of degenerative osteoarthritis under general anesthesia.

2. Surgery time does not exceed 100 minutes.

3. Patients without previous opioid medication.

4. Patients ranged 45-85 years old.

5. Patients who have given informed consent.

Exclusion Criteria:

1. Pregnant or nursing females.

2. Recidivist alcoholics.

3. Local or systemic infection.

4. Age < 45 and > 85 years.

5. Surgery time more than 100 minutes.

6. Intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines).

7. Patients consumed opioid medication before surgery.

8. Patients with prosthetic or damaged cardiac valves.

9. Patients who are unable to understand the consent form.

10. History of psychiatric disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Total Hip Arthroplasty

Intervention

Procedure:
• Auricular acupuncture (procedure)

Locations

Country	Name	City	State
Germany	University of Berlin, Campus Charite	Berlin
Germany	Ernst Moritz Arndt University	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	Humboldt-Universität zu Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative analgesics requirement