Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-01-29 @ 4:05 AM
Study NCT ID:
NCT02062320
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment and Evaluation of a Post Caesarean Acute Pain Service (PCAPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-12', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '72 hours after Caesarean Section (CS)', 'description': 'Comparison of pain intensity (Visual Analogue Scale (VAS)) during the postoperative period (72 hours) between the two groups according to postoperative analgesic method and method of anaesthesia.'}], 'secondaryOutcomes': [{'measure': 'VAS score above 4', 'timeFrame': '72 hours after CS', 'description': 'unsatisfactory pain relief'}, {'measure': 'Additional Analgesic Requests (AAR) Count', 'timeFrame': '72 hours after CS', 'description': 'Comparison of the average value of the AARs count in groups in the first 72 hours after CS'}, {'measure': 'Analgesia related complication Rate', 'timeFrame': '72 hours after CS', 'description': 'Analgesia related complications including hypotension, hypertension, tachycardia, bradycardia, hypoventilation were recorded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Pain Service', 'postoperative analgesia', 'Caesarean Section', 'non-opioid analgesia', 'opioid analgesia', 'epidural analgesia'], 'conditions': ['The Efficacy of Analgesic Methods After Caesarean Section']}, 'referencesModule': {'references': [{'pmid': '16798441', 'type': 'BACKGROUND', 'citation': 'Pan PH. Post cesarean delivery pain management: multimodal approach. Int J Obstet Anesth. 2006 Jul;15(3):185-8. doi: 10.1016/j.ijoa.2006.04.004. No abstract available.'}, {'pmid': '22345943', 'type': 'BACKGROUND', 'citation': 'Ismail S, Shahzad K, Shafiq F. Observational study to assess the effectiveness of postoperative pain management of patients undergoing elective cesarean section. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):36-40. doi: 10.4103/0970-9185.92432.'}, {'pmid': '23128818', 'type': 'BACKGROUND', 'citation': 'Stourac P, Suchomelova H, Stodulkova M, Huser M, Krikava I, Janku P, Haklova O, Hakl L, Stoudek R, Gal R, Sevcik P. Comparison of parturient - controlled remifentanil with epidural bupivacain and sufentanil for labour analgesia: randomised controlled trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2014 Jun;158(2):227-32. doi: 10.5507/bp.2012.073. Epub 2012 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the efficacy of analgesic methods after Caesarean Section before and after Post Caesarean Acute Pain Service establishing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We evaluated all patients undergoing delivery via Caesarean Section under anaesthesia in the period 10/2009 - 10/2011.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caesarean Section performed from October 2009 to October 2011 (study period)\n* completed "Evaluation of postoperative analgesia after Caesarean Section" form.\n\nExclusion Criteria:\n\n* Not completed "Standard Evaluation of postoperative analgesia after Caesarean Section" form.'}, 'identificationModule': {'nctId': 'NCT02062320', 'acronym': 'PCAPS', 'briefTitle': 'Establishment and Evaluation of a Post Caesarean Acute Pain Service (PCAPS)', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Establishment and Evaluation of a Post Caesarean Acute Pain Service', 'orgStudyIdInfo': {'id': 'NT13906-4/2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRE-PCAPS', 'description': 'Parturients who underwent delivery by Caesarean Section in the period October 2009 - September 2010'}, {'label': 'POST-PCAPS', 'description': 'Parturients who underwent delivery by Caesarean Section in the period November 2010 - October 2011.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 00', 'city': 'Brno', 'state': 'South Moravian', 'country': 'Czechia', 'facility': 'Faculty Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Petr Štourač, MD, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Brno Faculty Hospital, departement of anesthesiology and intensive care medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D.', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}