Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00233857
Status:
COMPLETED
Last Update Posted:
2011-02-28
First Post:
2005-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020831', 'term': 'Acupuncture, Ear'}], 'ancestors': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055097', 'term': 'Auriculotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-25', 'studyFirstSubmitDate': '2005-10-05', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative ibuprofen requirement after the surgery'}], 'secondaryOutcomes': [{'measure': 'Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects'}]}, 'conditionsModule': {'keywords': ['Acute pain', 'postoperative pain', 'auricular acupuncture'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with an American Society of Anesthesiologists physical status of I to II scheduled for ambulatory knee arthroscopy under general anesthesia.\n2. Surgery time does not exceed 60 minutes.\n3. Patients without previous opioid and/or psychiatric medication.\n4. Patients ranged 16-65 years old.\n5. Patients able to use Visual Analogue Scale-100 for pain intensity measurement.\n6. Patients who have given informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or nursing females.\n2. Recidivist alcoholics and/or patients with history of psychiatric disease.\n3. Local or systemic infection.\n4. Age \\< 16 and \\> 65 years.\n5. Surgery time more than 60 minutes.\n6. Inability to use Visual Analogue Scale-100.\n7. Patients consumed opioid medication before surgery.\n8. Patients with prosthetic or damaged cardiac valves (s. Potential risks)\n9. Patients who are unable to understand the consent form.'}, 'identificationModule': {'nctId': 'NCT00233857', 'briefTitle': 'Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'III UV 23/03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Auricular acupuncture', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17487', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'overallOfficials': [{'name': 'Taras I. Usichenko, Assistant Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}}}}