Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy

This study has been completed.
Sponsor:
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00233857
First received: October 5, 2005
Last updated: February 25, 2011
Last verified: February 2011
  Purpose

The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute postoperative pain and in reduction of analgesics consumption on demand and their side effects in patients after ambulatory knee arthroscopy


Condition Intervention Phase
Postoperative Pain
Procedure: Auricular acupuncture
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • Postoperative ibuprofen requirement after the surgery

Secondary Outcome Measures:
  • Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects

Estimated Enrollment: 120
Study Start Date: August 2003
Study Completion Date: August 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 65 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 II scheduled for ambulatory knee arthroscopy under general anesthesia.
  2. Surgery time does not exceed 60 minutes.
  3. Patients without previous opioid and/or psychiatric medication.
  4. Patients ranged 16-65 years old.
  5. Patients able to use Visual Analogue Scale-100 for pain intensity measurement.
  6. Patients who have given informed consent.

Exclusion Criteria:

  1. Pregnant or nursing females.
  2. Recidivist alcoholics and/or patients with history of psychiatric disease.
  3. Local or systemic infection.
  4. Age < 16 and > 65 years.
  5. Surgery time more than 60 minutes.
  6. Inability to use Visual Analogue Scale-100.
  7. Patients consumed opioid medication before surgery.
  8. Patients with prosthetic or damaged cardiac valves (s. Potential risks)
  9. Patients who are unable to understand the consent form.
  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: NCT00233857

Locations
Germany
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Greifswald, Germany, 17487
Sponsors and Collaborators
University Medicine Greifswald
Investigators
Principal Investigator: Taras I. Usichenko, Assistant Professor Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233857     History of Changes
Other Study ID Numbers: III UV 23/03
Study First Received: October 5, 2005
Last Updated: February 25, 2011
Health Authority: European Union: European Medicines Agency

Keywords provided by University Medicine Greifswald:
Acute pain
postoperative pain
auricular acupuncture

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014