Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT02369133
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2015-02-17', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain scores measured by visual analog scale (VAS)', 'timeFrame': 'Postoperative 24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cesarean Section; Dehiscence']}, 'descriptionModule': {'briefSummary': 'The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin-related side effects in patients undergoing cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 20-40 years,\n* ASA physical status 1-2 who underwent elective cesarean surgery during general anesthesia were included in the study\n\nExclusion Criteria:\n\n* A history of allergy to any of the study medications (opiod, general anesthetic agents or paracetamol),\n* history of opioid or paracetamol use,\n* hepatic or renal failure,\n* any psychological disorders,\n* complications during cesarean section and unable to use PCIA device were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT02369133', 'briefTitle': 'Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KA 13-180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Paracetamol (Group P),', 'description': 'Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol', 'interventionNames': ['Drug: paracetamol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group Saline (Group S)', 'description': 'Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group S (n = 30) received 100 ml iv %0,9 saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'paracetamol', 'type': 'DRUG', 'description': 'Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol, patients in group S (n = 30) received 100 ml iv %0.9 NaCl', 'armGroupLabels': ['Group Paracetamol (Group P),']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Group Saline (Group S)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Ozlem Ozmete', 'investigatorAffiliation': 'Baskent University'}}}}