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Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

NCT ID: NCT00334165

Last Updated: 2011-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-06-30

Brief Summary

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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

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Conditions

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Acute Pain Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Auricular acupuncture (procedure)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humboldt-Universität zu Berlin

OTHER

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Principal Investigators

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Taras I Usichenko, M.D.

Role: STUDY_CHAIR

Ernst Moritz Arndt University

Locations

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University of Berlin, Campus Charite

Berlin, , Germany

Site Status

Ernst Moritz Arndt University

Greifswald, , Germany

Site Status

Countries

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Germany

Other Identifiers

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III UV 13/05

Identifier Type: -

Identifier Source: org_study_id