Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT02137135
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2014-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Menstrual Phase and Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-12', 'studyFirstSubmitDate': '2014-05-12', 'studyFirstSubmitQcDate': '2014-05-12', 'lastUpdatePostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life was evaluated with SF 12 test.', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'The anxiety and depression was evaluated with Hospital anxiety and depression scale.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic postoperative pain', 'menstrual cycle'], 'conditions': ['Acute Postoperative Pain', 'Chronic Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '16023915', 'type': 'RESULT', 'citation': 'Kuba T, Quinones-Jenab V. The role of female gonadal hormones in behavioral sex differences in persistent and chronic pain: clinical versus preclinical studies. Brain Res Bull. 2005 Aug 15;66(3):179-88. doi: 10.1016/j.brainresbull.2005.05.009.'}]}, 'descriptionModule': {'briefSummary': 'Fluctuations of female sex hormones during the menstrual cycle influence pain perception. Endogenous pain is pronounced in the follicular phase of the menstrual cycle. The investigators tested the primary hypothesis that the women having surgery during their follicular phase have more acute pain and require more opioids than those in the luteal phase, and secondarily the investigators tested that women who have surgery during their follicular phase have more incisional pain at 3 month postoperatively.', 'detailedDescription': '127 adult females having laparoscopic cholecystectomy were randomized to have surgery during the luteal or follicular phase of their menstrual cycle. Standardized anesthesia and pain management regimen was given to all patients. Pain and analgesic consumption were evaluated in PACU and every four hours in first 24 hours. Adverse effects were also questioned every four hours. Time to oral intake and ambulation were recorded. Post-surgical pain, hospital anxiety and depression scale, and SF-12 questionnaire were also evaluated at 1- and 3-month visits.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with a negative urine pregnancy test\n\nExclusion Criteria:\n\n* Patients with pre-existing pain syndromes\n* Patients using routinely using opioids\n* Patients using hormone preparations in the last 6 months\n* Patients with hysterectomy\n* Patients breastfeeding in the previous 6 months\n* Patients with body mass index \\>35 kg/m2'}, 'identificationModule': {'nctId': 'NCT02137135', 'briefTitle': 'Menstrual Phase and Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'The Influence of the Menstrual Cycle on Acute and Persistent Pain After Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'SARI-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'follicular phase', 'description': 'Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.', 'interventionNames': ['Other: HAD scale', 'Other: The SF 12 test', 'Other: Visual analogue score']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'luteal phase', 'description': 'Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.', 'interventionNames': ['Other: HAD scale', 'Other: The SF 12 test', 'Other: Visual analogue score']}], 'interventions': [{'name': 'HAD scale', 'type': 'OTHER', 'otherNames': ['The anxiety/depression scale'], 'description': 'The anxiety/depression scale (HAD) was used to assess anxiety and depression.', 'armGroupLabels': ['follicular phase', 'luteal phase']}, {'name': 'The SF 12 test', 'type': 'OTHER', 'otherNames': ['SHORT FORM 12'], 'description': 'The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.', 'armGroupLabels': ['follicular phase', 'luteal phase']}, {'name': 'Visual analogue score', 'type': 'OTHER', 'otherNames': ['VAS score'], 'description': 'Visual analogue score vas used to evaluate pain.', 'armGroupLabels': ['follicular phase', 'luteal phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'overallOfficials': [{'name': 'Betul Kozanhan, Specialist Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey'}, {'name': 'Ayse Ilksen Egilmez, Specialist Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konya Education and Research Hospital, Anesthesiology and Reanimation Department, Konya; Turkey'}, {'name': 'Aykut Soyder, Assistant Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adnan Menderes University Medical Faculty, General Surgery Department, Aydin; Turkey'}, {'name': 'Fabrizio Galimberti, Medical Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio'}, {'name': 'Daniel I. Sessler, Professor and Ch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Outcomes Research, Cleveland Clinic'}, {'name': 'Alparslan Turan, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Anesthesiology, Department of Outcomes Research, Cleveland Clinic'}, {'name': 'Osman Nuri Aydın, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Assistant Professor', 'investigatorFullName': 'SINEM SARI', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}