Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-04 @ 9:36 PM
Study NCT ID:
NCT02803450
Status:
WITHDRAWN
Last Update Posted:
2021-09-27
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidural Loading: High Volume, Low Concentration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The protocol will be rewritten.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Pain Levels (VAS Assessment)', 'timeFrame': 'During Labor', 'description': 'Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'During labor', 'description': 'Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care.'}], 'secondaryOutcomes': [{'measure': 'Analgesic level', 'timeFrame': '20 minutes', 'description': 'Pinprick every 10, 15, and 20 minutes following loading'}, {'measure': 'Maternal Vital Signs', 'timeFrame': '20 minutes', 'description': 'Measure change in maternal blood pressure and heart rate over 20 minutes following loading.'}, {'measure': 'Fetal Heart Rate', 'timeFrame': '20 minutes', 'description': 'Measure change in fetal heart rate following loading.'}, {'measure': 'Rescue Bolus', 'timeFrame': 'During Labor', 'description': 'Measure number of rescue bolus doses and total anesthetic dose'}, {'measure': 'Intravascular Catheter Placement', 'timeFrame': 'During labor', 'description': 'Measure incidence of intravascular catheter placement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Effects of; Anesthesia', 'spinal and epidural'], 'conditions': ['Labor and Delivery']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter.', 'detailedDescription': 'This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Control patients will receive local anesthetic in lower volume more concentrated solution via the epidural catheter which is current standard practice. Outcome measures will include quantifying pain relief with respect to time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients will be recruited for each of the three arms of the study, totaling 105 patients, in order to obtain significance when performing statistical analyses following complete enrollment in the study. The impetus of this study involves investigation of the effects of loading the epidural space with high volume, low concentration local anesthetic via two different modalities and studying which method is more efficacious.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who have volunteered and consented to participation in the study upon admission to labor and delivery\n2. Parturients in active labor requesting epidural analgesia\n3. Uncomplicated pregnancy with a reassuring fetal heart tracing\n4. Age greater than or equal to 18 years\n\nExclusion Criteria:\n\n1. Contraindication to epidural anesthesia\n2. Inability to read, comprehend, and sign the informed consent form\n3. Fetal intrauterine growth retardation (IUGR)\n4. Non-reassuring fetal heart tracing\n5. Cervical dilation greater than 7cm\n6. Intra-uterine fetal demise\n7. History of chronic pain other than in the back\n8. Incarcerated patients I. Any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (\\>3 attempts, presence of CSF)\n\nj. Any evidence of high spinal after initial bolus or continuous infusion of high volume, low concentration local anesthetic solution k. Women undergoing cesarean section'}, 'identificationModule': {'nctId': 'NCT02803450', 'briefTitle': 'Epidural Loading: High Volume, Low Concentration', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?', 'orgStudyIdInfo': {'id': '2013H0188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Volume, Low Concentration via Epidural Needle', 'description': 'Epidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via epidural needle followed by catheter placement.\n\nFor continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr.\n\nFor inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.', 'interventionNames': ['Procedure: Epidural needle']}, {'type': 'EXPERIMENTAL', 'label': 'High Volume, Low Concentration via Epidural Catheter', 'description': 'Epidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via the epidural catheter administration following catheter placement.\n\nFor continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr.\n\nFor inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.', 'interventionNames': ['Procedure: Catheter Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Volume, High Concentration via Epidural Catheter', 'description': 'Standard of Care Epidural Administration Epidural loading: Participants will receive 10ml of 0.125% bupivacaine with fentanyl 2mcg/ml in 5 ml increments 5 minutes apart via the epidural catheter following epidural catheter placement, per standard of care.\n\nFor continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.0625% bupivacaine with 2mcg/ml fentanyl. The infusion rate will be set at 10ml/hr basal rate and 4ml every 15 minutes on demand with lockout of 26ml/hr.\n\nFor inadequate analgesia: One additional 5ml boluses of the standard 0.125% bupivacaine with 2mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.', 'interventionNames': ['Procedure: Standard of Care Epidural Administration']}], 'interventions': [{'name': 'Epidural needle', 'type': 'PROCEDURE', 'description': 'Medication administration via epidural needle.', 'armGroupLabels': ['High Volume, Low Concentration via Epidural Needle']}, {'name': 'Catheter Administration', 'type': 'PROCEDURE', 'description': 'Medication administration via epidural catheter.', 'armGroupLabels': ['High Volume, Low Concentration via Epidural Catheter']}, {'name': 'Standard of Care Epidural Administration', 'type': 'PROCEDURE', 'otherNames': ['Epidural catheter'], 'description': 'Medication administered at higher concentration, lower volume via epidural catheter.', 'armGroupLabels': ['Low Volume, High Concentration via Epidural Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Goran Ristev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ohio State Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor of Anesthesiology', 'investigatorFullName': 'Goran Ristev', 'investigatorAffiliation': 'Ohio State University'}}}}