Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334165
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : February 28, 2011
Sponsor:
Collaborator:
Humboldt-Universität zu Berlin
Information provided by:
University Medicine Greifswald

Tracking Information
First Submitted Date  ICMJE June 3, 2006
First Posted Date  ICMJE June 6, 2006
Last Update Posted Date February 28, 2011
Study Start Date  ICMJE June 2005
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2006)
Intraoperative analgesics requirement
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00334165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Auricular Acupuncture for Analgesia During Total Hip Arthroplasty
Official Title  ICMJE Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pain
  • Total Hip Arthroplasty
Intervention  ICMJE Procedure: Auricular acupuncture (procedure)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 5, 2006)
360
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2008
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00334165
Other Study ID Numbers  ICMJE III UV 13/05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Medicine Greifswald
Collaborators  ICMJE Humboldt-Universität zu Berlin
Investigators  ICMJE
Study Chair: Taras I Usichenko, M.D. Ernst Moritz Arndt University
PRS Account University Medicine Greifswald
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP