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Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

Primary Purpose

Acute Pain, Total Hip Arthroplasty

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Auricular acupuncture (procedure)
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Surgery time does not exceed 100 minutes. Patients without previous opioid medication. Patients ranged 45-85 years old. Patients who have given informed consent. Exclusion Criteria: Pregnant or nursing females. Recidivist alcoholics. Local or systemic infection. Age < 45 and > 85 years. Surgery time more than 100 minutes. Intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines). Patients consumed opioid medication before surgery. Patients with prosthetic or damaged cardiac valves. Patients who are unable to understand the consent form. History of psychiatric disease.

Sites / Locations

  • University of Berlin, Campus Charite
  • Ernst Moritz Arndt University

Outcomes

Primary Outcome Measures

Intraoperative analgesics requirement

Secondary Outcome Measures

Full Information

First Posted
June 3, 2006
Last Updated
February 25, 2011
Sponsor
University Medicine Greifswald
Collaborators
Humboldt-Universität zu Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT00334165
Brief Title
Auricular Acupuncture for Analgesia During Total Hip Arthroplasty
Official Title
Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
June 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Medicine Greifswald
Collaborators
Humboldt-Universität zu Berlin

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Total Hip Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Auricular acupuncture (procedure)
Primary Outcome Measure Information:
Title
Intraoperative analgesics requirement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Surgery time does not exceed 100 minutes. Patients without previous opioid medication. Patients ranged 45-85 years old. Patients who have given informed consent. Exclusion Criteria: Pregnant or nursing females. Recidivist alcoholics. Local or systemic infection. Age < 45 and > 85 years. Surgery time more than 100 minutes. Intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines). Patients consumed opioid medication before surgery. Patients with prosthetic or damaged cardiac valves. Patients who are unable to understand the consent form. History of psychiatric disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taras I Usichenko, M.D.
Organizational Affiliation
Ernst Moritz Arndt University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Berlin, Campus Charite
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Ernst Moritz Arndt University
City
Greifswald
ZIP/Postal Code
17475
Country
Germany

12. IPD Sharing Statement

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Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

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