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Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Humboldt-Universität zu Berlin
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00334165
First received: June 3, 2006
Last updated: February 25, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Acute Pain
Total Hip Arthroplasty
Procedure: Auricular acupuncture (procedure)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • Intraoperative analgesics requirement

Estimated Enrollment: 360
Study Start Date: June 2005
Estimated Study Completion Date: June 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334165

Locations
Germany
University of Berlin, Campus Charite
Berlin, Germany, 10117
Ernst Moritz Arndt University
Greifswald, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
Humboldt-Universität zu Berlin
Investigators
Study Chair: Taras I Usichenko, M.D. Ernst Moritz Arndt University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00334165     History of Changes
Other Study ID Numbers: III UV 13/05
Study First Received: June 3, 2006
Last Updated: February 25, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014