Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT03460093
Status:
COMPLETED
Last Update Posted:
2019-03-19
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-04', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain score', 'timeFrame': 'postoperative 1. hour', 'description': 'postoperative pain score evaluated with Visual Analog Scale'}, {'measure': 'postoperative pain score', 'timeFrame': 'postoperative 6. hour', 'description': 'postoperative pain score evaluated with Visual Analog Scale'}, {'measure': 'postoperative pain score', 'timeFrame': 'postoperative 12. hour', 'description': 'postoperative pain score evaluated with Visual Analog Scale'}, {'measure': 'postoperative pain score', 'timeFrame': 'postoperative 24. hour', 'description': 'postoperative pain score evaluated with Visual Analog Scale'}, {'measure': 'postoperative pain score', 'timeFrame': 'postoperative 48. hour', 'description': 'postoperative pain score evaluated with Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'postoperative analgesic consumption', 'timeFrame': 'postoperative 48 hours', 'description': 'the amount of analgesic used (NSAIDs...) for pain relief after operation'}, {'measure': 'postoperative passing of gas and bowel movements', 'timeFrame': 'postoperative 48 hours', 'description': 'the hour of postoperative gas extraction and bowel movements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nerve blockade', 'hypogastric plexus', 'cesarean section'], 'conditions': ['Superior Hypogastric Plexus Block']}, 'descriptionModule': {'briefSummary': 'PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section', 'detailedDescription': 'Superior hypogastric plexus block(SHPB) for pain relief is routinely implemented in cesarean section operations at H.S.U Kocaeli Derince Education and Research Hospital. The implementation of this procedure depends on the clinical situation of the patient, the preference of the surgeon and the anesthesiologist, the course of the operation, and whether the patient wishes or not. Superior hypogastric plexus block is performed with 0.25 % bupivacaine 30 ml injected under peritoneum above promontorium.\n\nThis is a prospective case-control study. The sample consisted of 60 women having cesarean-section with general anesthesia at H.S.U Kocaeli Derince Education and Research Hospital divided into two groups: the first group having superior hypogastric plexus block for pain relief and the control group not having superior hypogastric plexus block. All participants signed an informed consent and the study was approved by the Ethics Committee of Kocaeli University ( KUGOKAEK 2017/270). The sample size was calculated with G Power 3.1 program. With ki-square Goodness-of-fit test α:0.05 ,power 95% ,effect size 0.5 total sample size was calculated 52, including 26 in case group and 26 in control group. Women having cesarean-section with spinal anesthesia, women with known bupivacaine allergy, women with anxiety-depression disorder, women with known fibromyalgia were not enrolled to the study. Age, BMI(body mass index), education status, VAS (visual analog scale) scores ,the amount of analgesic used and the hour of gas extraction and bowel movement will be recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, pregnant, literate women having cesarean-section operation with general anesthesia at H.S.U Kocaeli Derince Education and Research Hospital Obstetrics and Gynecology Clinics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women having cesarean-section operation at H.S.U Kocaeli Derince Education and Research Hospital with general anesthesia,\n* Women agree to participate in the study,\n* Literate women.\n\nExclusion Criteria:\n\n* Women having cesarean-section with spinal anesthesia,\n* Women with known bupivacaine and NSAIDS allergy,\n* Women with anxiety-depression disorder,\n* Women with known fibromyalgia.\n* Insufficient ability to understand information in Turkish'}, 'identificationModule': {'nctId': 'NCT03460093', 'briefTitle': 'Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli Derince Education and Research Hospital'}, 'officialTitle': 'Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section: A Prospective Case-Control Study', 'orgStudyIdInfo': {'id': 'KUGOKAEK 2017/270'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'case (SHPB+)', 'description': 'Superior hypogastric plexus block present'}, {'label': 'control (SHPB-)', 'description': 'Superior hypogastric plexus block not present'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'S.B.U Kocaeli Derince Education and Research Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'bahar sarıibrahim astepe, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S.B.U Kocaeli Derince Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli Derince Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'obstetrics and gynecology specialist', 'investigatorFullName': 'bahar sarıibrahim astepe', 'investigatorAffiliation': 'Kocaeli Derince Education and Research Hospital'}}}}