Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 5:20 PM
Study NCT ID:
NCT01563835
Status:
TERMINATED
Last Update Posted:
2014-10-13
First Post:
2012-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia for 2nd Trimester Termination of Pregnancy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'Recruitment difficulty', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Recovery - 40 score on discharge', 'timeFrame': 'up to 5 days', 'description': 'The primary outcome of this study will be the difference between IV PCA and PCEA groups in aggregate score of Quality of Recovery - 40 on discharge from hospital.'}], 'secondaryOutcomes': [{'measure': 'Duration of procedure', 'timeFrame': '24 hours', 'description': 'Duration of procedure from induction to abortion in hours'}, {'measure': 'Pain score', 'timeFrame': '24 hours', 'description': 'Visual analog pain score every 30 minutes during procedure'}, {'measure': 'Narcotic-related complications', 'timeFrame': '24 hours', 'description': 'Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression.'}, {'measure': 'Epidural-related complications', 'timeFrame': '24 hours', 'description': 'Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications.'}, {'measure': 'Surgical intervention', 'timeFrame': '24 hours', 'description': 'Incidence of surgical intervention and any anesthetic required for intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Termination of pregnancy', 'Epidural', 'IV PCA'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'There has been very little investigation into the management of pain from 2nd trimester termination of pregnancy or unexpected fetal loss. The standard of practice in North America is usually intravenous patient controlled analgesia (IV PCA), using a narcotic wuch as fentanyl. The goal of this study is to compare the quality of recovery after termination of pregnancy using fentanyl IV PCA or patient controlled epidural analgesia (PCEA), a standard of care for live births. The study will be conducted as a randomized controlled trial.', 'detailedDescription': "Epidural analgesia is known to provide superior analgesia for labour with minimal maternal and fetal side effects. This mode of analgesia is not usually offered to patients who require termination of their pregnancies or who suffer unexpected fetal losses, although they go through labour and delivery with likely more difficult psychological circumstances.\n\nWe plan to compare patient controlled epidural analgesia (PCEA) with intravenous patient controlled analgesia (IV PCA), for 2nd trimester terminations of pregnancy. We hypothesize that PCEA provides better quality of recovery than IV PCA. The previously validated Quality of Recovery - 40 questionnaire will be used to measure a patient's quality of recovery. The results of this study will determine the optimal method of pain relief for late termination of pregnancy or fetal loss."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* interruption of pregnancy between 12 and 23 6/7 weeks\n\nExclusion Criteria:\n\n* documented allergy to fentanyl or bupivacaine\n* coagulopathy\n* drug or narcotic abuse\n* contraindication to neuraxial analgesia\n* inability to comply with IVPCA or PCEA\n* inability to complete the QoR-40 questionnaire\n* TOP due to maternal problems'}, 'identificationModule': {'nctId': 'NCT01563835', 'briefTitle': 'Analgesia for 2nd Trimester Termination of Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia', 'orgStudyIdInfo': {'id': '12-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural (PCEA)', 'description': 'bupivacaine, fentanyl', 'interventionNames': ['Drug: bupivacaine, fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV PCA', 'description': 'Intravenous fentanyl patient controlled analgesia', 'interventionNames': ['Drug: fentanyl']}], 'interventions': [{'name': 'bupivacaine, fentanyl', 'type': 'DRUG', 'otherNames': ['bupivacaine: Marcaine', 'fentanyl: fentanyl citrate'], 'description': '10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.', 'armGroupLabels': ['Epidural (PCEA)']}, {'name': 'fentanyl', 'type': 'DRUG', 'otherNames': ['fentanyl citrate'], 'description': 'fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.', 'armGroupLabels': ['IV PCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jose CA Carvalho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}