Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

February 25, 2011 updated by: University Medicine Greifswald

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • University of Berlin, Campus Charite
      • Greifswald, Germany, 17475
        • Ernst Moritz Arndt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Intraoperative analgesics requirement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

Humboldt-Universität zu Berlin

Investigators

  • Study Chair: Taras I Usichenko, M.D., Ernst Moritz Arndt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion

June 1, 2008

Study Registration Dates

First Submitted

June 3, 2006

First Submitted That Met QC Criteria

June 5, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2011

Last Update Submitted That Met QC Criteria

February 25, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • III UV 13/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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