Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT02332395
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2015-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Postoperative Pain After Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-18', 'studyFirstSubmitDate': '2015-01-05', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total amount of analgesics', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'numerical rating scale', 'timeFrame': '24 hours'}, {'measure': 'pain catastrophizing scale', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'pain catastrophizing', 'cesarean section'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Taşdemir A, Erakgün A, Nuri Deniz M, ÇertuğA . Preoperatif Bilgilendirme Yapılan Hastalarda Ameliyat öncesi ve Sonrası Anksiyete Düzeylerinin State-Trait Anxiety Inventory Test ile Karşılaştırılması. Turkish Journal Anaesthesiology and Reanimation 41(2): 44-9, 2013.'}, {'type': 'BACKGROUND', 'citation': 'Kırdemir P, Özorak Ö. Postoperatif Ağrı ve Analjezik İhtiyacı Preoperatif Dönemde Tahmin Edilebilir mi? Turkiye Klinikleri Journal of Medical Sciences 31(4):951-9, 2011.'}, {'type': 'BACKGROUND', 'citation': 'Hüseyinoğlu Ü, Ülker K, Temur İ, Kütük M. Elektif Sezaryen Doğum Sonrası Postoperatif Ağrı Gideriminde Meperidin ve Tramadolün Karșılaștırılması: Bir Prospektif Randomize Çalıșma. Kafkas Journal of Medical Sciences 1(2):53-56, 2011.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations. Patients whose undergo caesarean section operation are included into this study. Patients will invite to complete the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be divided into two groups in terms of applied surgical priority whether emergency or elective. After caesarean section, patient controlled analgesia is used for pain relief. And the intensity of pain will be measured by using numerical rating scale.', 'detailedDescription': 'Pain is the main problem of postoperative period. Postoperative analgesic consumption can be associated with physical and psychological condition of the individual. This study is aimed to investigate the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations.\n\nPatients are invited to complete the pain catastrophizing scale questionnaire in preoperative period.\n\nA total of 100 patients will be included into the study. Patients are divided into two groups in terms of surgical priority whether emergency or elective. Spinal or general anesthesia will be performed to the patients. In postoperative period, patient controlled analgesia will be applied for pain relief and numerical rating scale is used to determine the pain intensity in 1st, 2nd, 6th, 12th, 24th hours. The analgesic consumption in 24 hours will be recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'individuals whose underwent caesarean section operation in terms of surgical priority whether emergency or elective', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists score of 1 or 3 and 1-Emergency or 3-Emergency\n\nExclusion Criteria:\n\n* Patients whose not to participate\n* Patients whose have communication problems\n* Patients whose have been using antipsychotic or antidepressant drugs'}, 'identificationModule': {'nctId': 'NCT02332395', 'briefTitle': 'The Evaluation of Postoperative Pain After Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'The Evaluation of Postoperative Pain After Emergency and Elective Caesarean Section Operations', 'orgStudyIdInfo': {'id': '13-KAEK-226'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emergency caesarean section', 'description': 'patients whose underwent emergency caesarean section operation'}, {'label': 'Elective caesarean section', 'description': 'patients whose underwent elective caesarean section operation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60200', 'city': 'Tokat Province', 'state': 'Tokat Province', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpasa University', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}], 'overallOfficials': [{'name': 'Hakan Tapar, Ass.Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziosmanpasa University, Medical Faculty, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, MD', 'investigatorFullName': 'Hakan Tapar', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}