Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT06178458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Score and Opioid Consumption of Index and Previous Cesarean Delivery
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 416}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of pain score after cesarean delivery', 'timeFrame': 'January 2024 - December 2025', 'description': 'To predict pain score of index cesarean delivery from previous cesarean delivery using pain score measured by verbal numerical rating scale (VNRS) ranging from 0 (no pain) to 10 (worst pain imaginable).'}], 'secondaryOutcomes': [{'measure': 'Prediction of opioid consumption after cesarean delivery', 'timeFrame': 'January 2024 - December 2025', 'description': 'To predict opioid consumption of index cesarean delivery from previous cesarean delivery based on 1. number and percentage of patients who required opioid for controlling postoperative pain, 2. MME (milligram morphine equivalent) per total patients and 3. MME per patients who received opioid'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean delivery', 'opioid consumption', 'pain score'], 'conditions': ['Pain', 'Postoperative']}, 'descriptionModule': {'briefSummary': 'Postoperative pain after cesarean delivery is common and affects on both mothers and children.\n\nThe goals of this retrospective observational study aim to predict pain score and opioid consumption of index cesarean delivery from pain score and opioid consumption of previous cesarean delivery.', 'detailedDescription': 'The authors will review the medical records of recruited participants for demographic data as well as pain scores and opioid consumption of index cesarean delivery and previous cesarean delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for cesarean delivery under spinal anesthesia with intrathecal morphine.', 'genderDescription': 'Female because only females can have cesarean delivery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had at least 2 cesarean deliveries\n* Patients received spinal anesthesia and intrathecal morphine for cesarean delivery\n* Patients received postoperative pain control as per standard protocol\n\nExclusion Criteria:\n\n* Patients with chronic pain prior to cesarean delivery\n* Unable to give pain score\n* Receiving general anesthesia for cesarean delivery\n* Receiving postoperative pain control beyond the standard protocol\n* Patients with multiple pregnancy, placenta abruption, placenta accrete, postpartum hemorrhage\n* Patients with psychotic disorder'}, 'identificationModule': {'nctId': 'NCT06178458', 'briefTitle': 'Pain Score and Opioid Consumption of Index and Previous Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Prediction of Pain Score and Opioid Consumption of Index Cesarean Delivery From Pain Score and Opioid Consumption of Previous Cesarean Delivery: A Retrospective Study', 'orgStudyIdInfo': {'id': '66-348-8-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'To collect data of pain score and opioid consumption of index and previous cesarean delivery'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sasikaan Nimmaanrat, MD, MMed', 'role': 'CONTACT', 'email': 'snimmaanrat@yahoo.com.au', 'phone': '+66887907842'}, {'name': 'Boonsin Tangtrakulwanich, MD', 'role': 'CONTACT', 'email': 'medpsu.ec@gmail.com', 'phone': '+6674451149'}], 'overallOfficials': [{'name': 'Boonsin Tangtrakulwanich, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Prince of Songkla University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD to be shared upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sasikaan Nimmaanrat', 'investigatorAffiliation': 'Prince of Songkla University'}}}}