Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-05 @ 12:07 AM
Study NCT ID:
NCT01442818
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2010-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-08-19', 'releaseDate': '2015-07-24'}, {'releaseDate': '2015-10-19', 'unreleaseDateUnknown': True}, {'resetDate': '2015-12-04', 'releaseDate': '2015-10-28'}, {'resetDate': '2017-02-09', 'releaseDate': '2016-12-19'}], 'estimatedResultsFirstSubmitDate': '2015-07-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2010-09-08', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Pain Control', 'timeFrame': 'post operative day 1', 'description': "Patient's reported pain on a VAS on all postoperative day one."}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction with Pain Control', 'timeFrame': 'post operative day 1', 'description': "Patient's satisfaction with pain control on a VAS on all postoperative day one."}, {'measure': 'patient perceived pain at 2 weeks', 'timeFrame': '2 weeks post op', 'description': "VAS for pain will be filled out at the patient's two week post op office visit."}, {'measure': 'patient dissatisfaction with pain control at 2 weeks', 'timeFrame': '2 weeks post op', 'description': 'patient will fill out a VAS for satisfaction with pain control at their two week post operative visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vaginal reconstructive surgery'], 'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.', 'detailedDescription': 'The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.\n\nIn order to determine if there is a significant correlation, secondary outcomes will include the daily and total narcotic volume used, common side effects from the opioid including nausea, vomiting, or pruritis, length of hospital stay, timing of flatus and first bowel movement, all complications, and procedure performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients will be limited to those from the Division of Urogynecology to ensure similar surgical techniques. They will be between the ages of 18 and 70 and undergoing major vaginal reconstruction.\n* All patients must undergo vaginal reconstructive surgery including: anterior repair, posterior repair, and intraperitoneal vaginal vault suspension. The addition of vaginal hysterectomy, enterocele repair, or suburethral sling is not cause for exclusion.\n\nExclusion Criteria:\n\n* Any patient who has an allergy to hydromorphone/Dilaudid.\n* Any patient already taking chronic opioids, defined as daily use.\n* All patients with renal insufficiency or failure.\n* All patients with liver failure.\n* Any patient who is not having general anesthesia.\n* Any patient undergoing abdominal or laparoscopic procedures: sacral colpopexy, laparoscopic hysterectomy or oophorectomy, Burch procedure, or any procedure that enters the abdominal fascia.'}, 'identificationModule': {'nctId': 'NCT01442818', 'briefTitle': 'Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia', 'orgStudyIdInfo': {'id': '10072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scheduled IV post op', 'description': "Patient's will receive scheduled nurse administered IV pain medications post operatively.", 'interventionNames': ['Drug: Dilaudid IV Scheduled']}, {'type': 'EXPERIMENTAL', 'label': 'PCA post op', 'description': 'Patients will receive PCA for pain control post operatively.', 'interventionNames': ['Drug: Dilaudid PCA']}], 'interventions': [{'name': 'Dilaudid PCA', 'type': 'DRUG', 'otherNames': ['hydromorphone'], 'description': 'PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.', 'armGroupLabels': ['PCA post op']}, {'name': 'Dilaudid IV Scheduled', 'type': 'DRUG', 'otherNames': ['hydromorphone'], 'description': 'Nurse administered IV Dilaudid 0.5mg every 2 hours.', 'armGroupLabels': ['Scheduled IV post op']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45040', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Catrina C Crisp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth Division of Urogynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-07-24', 'type': 'RELEASE'}, {'date': '2015-08-19', 'type': 'RESET'}, {'date': '2015-10-19', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2015-10-28', 'type': 'RELEASE'}, {'date': '2015-12-04', 'type': 'RESET'}, {'date': '2016-12-19', 'type': 'RELEASE'}, {'date': '2017-02-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'TriHealth Inc.'}}}}