Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy
Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 postoperative-pain
Started Aug 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 5, 2005
CompletedFirst Posted
Study publicly available on registry
October 6, 2005
CompletedFebruary 28, 2011
February 1, 2011
11 months
October 5, 2005
February 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative ibuprofen requirement after the surgery
Secondary Outcomes (1)
Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects
Interventions
Eligibility Criteria
You may qualify if:
- Patients with an American Society of Anesthesiologists physical status of I to II scheduled for ambulatory knee arthroscopy under general anesthesia.
- Surgery time does not exceed 60 minutes.
- Patients without previous opioid and/or psychiatric medication.
- Patients ranged 16-65 years old.
- Patients able to use Visual Analogue Scale-100 for pain intensity measurement.
- Patients who have given informed consent.
You may not qualify if:
- Pregnant or nursing females.
- Recidivist alcoholics and/or patients with history of psychiatric disease.
- Local or systemic infection.
- Age \< 16 and \> 65 years.
- Surgery time more than 60 minutes.
- Inability to use Visual Analogue Scale-100.
- Patients consumed opioid medication before surgery.
- Patients with prosthetic or damaged cardiac valves (s. Potential risks)
- Patients who are unable to understand the consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Greifswald, 17487, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taras I. Usichenko, Assistant Professor
Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 5, 2005
First Posted
October 6, 2005
Study Start
August 1, 2003
Primary Completion
July 1, 2004
Study Completion
August 1, 2004
Last Updated
February 28, 2011
Record last verified: 2011-02