Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-26 @ 11:05 PM
Study NCT ID:
NCT03623256
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2018-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant will be blinded. The investigators will not be blinded because they are the same care providers. In addition, the volume of intrathecal anesthetic is different when bupivacaine plus fentanyl is used in comparison with only one medication used.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to one of four groups:\n\nGroup A: Spinal dose of preservative-free fentanyl 25 mcg. Group B: Spinal preservative-free 0.25% bupivacaine. Group C: Spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg.\n\nGroup D: Spinal preservative-free 0.25% bupivacaine and epidural fentanyl 100 mcg.\n\nAfter the procedure, we will monitor the fetal heart rate and tocometry tracings for 30 min. Thereafter, an epidural infusion with a solution containing 0.125% bupivacaine and 2mcg/mL of fentanyl will be started. We will record demographic variables (age, and BMI), obstetric variables (parity, gestational age, cervical dilation, oxytocin infusion) and anesthetic variables (level of insertion of epidural catheter). We will also record level of insertion, blood pressure every 5 minutes, dermatomal level, pain level, patient satisfaction level and pruritus.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 558}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal heart rate', 'timeFrame': '20 minutes (Starting from placement of labor neuraxial block)', 'description': 'Fetal bradycardia and abnormal fetal heart rate tracing'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '20 minutes (Starting from placement of labor neuraxial block)', 'description': 'Maternal systolic, diastolic and mean arterial pressure measured at baseline and every 5 minutes after administration of medication'}, {'measure': 'Dermatomal level', 'timeFrame': '20 minutes (Starting from placement of labor neuraxial block)', 'description': 'Analgesic level measured by sensitivity to temperature stimulus'}, {'measure': 'Maternal Pain level: visual analogue scale', 'timeFrame': '20 minutes (Starting from placement of labor neuraxial block)', 'description': 'Pain evaluated by visual analogue scale (0, no pain; 10, worst pain)'}, {'measure': 'Patient satisfaction level: Likert Scale', 'timeFrame': '20 minutes (Starting from placement of labor neuraxial block)', 'description': 'Satisfaction level measured by Likert Scale (5: fully satisfied, 4: satisfied, 3: neutral, 2: dissatisfied, 1: fully dissatisfied)'}, {'measure': 'Uterine tone', 'timeFrame': '20 minutes (Starting from placement of labor neuraxial block)', 'description': 'Measured with tocometer (In milimeters above baseline) at baseline and during 20 minutes after medication administration.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain', 'Obstetric Pain']}, 'descriptionModule': {'briefSummary': "There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Some authors have reported cases of parturients who developed uterine hyperactivity and fetal bradycardia after subarachnoid administration of fentanyl during labor. (D'Angelo \\& Eisenach, 1997) (Friedlander JD, 1997). It has been suggested that uterine hypertonus, leading to non-reassuring fetal heart rate tracings, might be an etiologic factor in these situations. (Landau, 2002).\n\nWe propose this study to test the hypothesis that administration of epidural fentanyl is associated with a lower incidence of fetal bradycardia compared to intrathecal fentanyl.", 'detailedDescription': 'After approval by the Institutional Review Board and written informed consent, we plan to prospectively study pregnant patients who undergo neuraxial labor analgesia. All patients will receive combined-spinal-epidural analgesia. Patients will be randomly assigned to one of four groups by means of sealed envelope technique. Group A will receive a spinal dose of preservative-free fentanyl 25 mcg. Group B will receive one dose of spinal preservative-free 0.25% bupivacaine. Group C will receive a spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg. Group D will receive spinal preservative-free 0.25% bupivacaine and epidural fentanyl 100 mcg. After the procedure, we will monitor the fetal heart rate and tocometry tracings for 20 min. Thereafter, an epidural infusion with a solution containing 0.125% bupivacaine and 2mcg/mL of fentanyl will be started. We will record demographic variables (age, and BMI), obstetric variables (parity, gestational age, cervical dilation, oxytocin infusion) and anesthetic variables (level of insertion of epidural catheter).\n\nPrimary outcomes:\n\nFetal heart rate (baseline, minimal and abnormal patterns)\n\nSecondary outcomes:\n\n* Blood pressure (systolic, diastolic and mean) measured at baseline and every 5 minutes after administration of medication.\n* Dermatomal level measured after 20 minutes of medication administration.\n* Pain level (visual analogue scale) after 20 minutes of medication administration.\n* Patient satisfaction level (1-10 scale) after 20 minutes of medication administration.\n* Uterine tone measured with tocometer at baseline and during 20 minutes after medication administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant patients in labor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Term pregnancy (\\> 37 weeks)\n* Absence of obstetric morbidities\n* Active labor\n* Request of neuraxial analgesia per patient and/or obstetrician\n* Combined spinal-epidural technique\n\nExclusion Criteria:\n\n* Abnormal fetal heart rate tracing.\n* Uterine tachysystole before neuraxial analgesia.\n* Baseline blood pressure \\<90/60 mmHg.\n* Allergies to local anesthetics or fentanyl.\n* Maternal fever.\n* Pruritus before performance of neuraxial analgesia.\n* Contraindications for neuraxial technique.\n* Unwillingness to participate.'}, 'identificationModule': {'nctId': 'NCT03623256', 'briefTitle': 'Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia', 'orgStudyIdInfo': {'id': '1238162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal Fentanyl', 'description': 'Spinal dose of preservative-free fentanyl 25 mcg (Volume 0.5 mL)', 'interventionNames': ['Drug: Spinal fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal Bupivacaine', 'description': 'Spinal dose of preservative-free 0.25% bupivacaine (Volume 0.5 mL)', 'interventionNames': ['Drug: Spinal bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal Fentanyl and Bupivacaine', 'description': 'Spinal combination of preservative-free 0.25% bupivacaine (0.5 mL) and fentanyl 25 mcg (0.5 mL). (Total Volume 1 mL).', 'interventionNames': ['Drug: Spinal Fentanyl and Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Epidural fentanyl /spinal bupivacaine', 'description': 'Spinal preservative-free 0.25% bupivacaine (Volume 0.5 mL) and epidural fentanyl 100 mcg (Volume 2 mL).', 'interventionNames': ['Drug: Epidural fentanyl /spinal bupivacaine']}], 'interventions': [{'name': 'Spinal fentanyl', 'type': 'DRUG', 'otherNames': ['Fentora'], 'description': '25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.', 'armGroupLabels': ['Spinal Fentanyl']}, {'name': 'Spinal bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': '1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route.', 'armGroupLabels': ['Spinal Bupivacaine']}, {'name': 'Spinal Fentanyl and Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine and Fentora'], 'description': '1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL), and 25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.', 'armGroupLabels': ['Spinal Fentanyl and Bupivacaine']}, {'name': 'Epidural fentanyl /spinal bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine and Fentora'], 'description': '1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route, and 100 mcg of fentanyl (2 mL) will be administered by epidural route.', 'armGroupLabels': ['Epidural fentanyl /spinal bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steffen Meiler, MD', 'role': 'CONTACT', 'email': 'smeiler@augusta.edu', 'phone': '706-721-3671'}], 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'centralContacts': [{'name': 'Efrain Riveros Perez, MD', 'role': 'CONTACT', 'email': 'eriverosperez@augusta.edu', 'phone': '7067217361'}, {'name': 'Alexander R Rocuts Martinez, MD', 'role': 'CONTACT', 'email': 'krocutsmartinez@augusta.edu', 'phone': '3304074681'}], 'overallOfficials': [{'name': 'Efrain Riveros Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The study team will decide about sharing information upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Department of Anesthesiology and Perioperative Medicine', 'investigatorFullName': 'Efrain Riveros Perez, MD', 'investigatorAffiliation': 'Augusta University'}}}}