Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-26 @ 11:57 PM
Study NCT ID:
NCT07076368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ropivacaine and Fentanyl for Labor Epidural Initiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single-center, double-blind, prospective study that will use a biased-coin-up-down allocation study design to quantify the effective volume in 90% of laboring patients (EDV) after a dural-puncture epidural (DPE) technique for neuraxial analgesia. We wish to declare that the participant, care providers, and outcomes assessor will be masked. The ClinicalTrials website does not allow us to tick these roles for a single-arm study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Pain score', 'timeFrame': '30 mins post-intervention', 'description': 'Numerical pain score using a discrete range from 0 (no pain) to 10 (most severe pain).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epidural', 'labor analgesia', 'pregnancy', 'obstetric anesthesia'], 'conditions': ['Pregnancy', 'Labor and Delivery', 'Labor Analgesia']}, 'referencesModule': {'references': [{'pmid': '28067707', 'type': 'BACKGROUND', 'citation': 'Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.'}, {'pmid': '39433721', 'type': 'BACKGROUND', 'citation': 'Song Y, Song Y, Sheng Z, Zhao Q, Liu W, Li Y, Zang Y, Xu Z, Liu Z. Exploration of the optimal programmed intermittent epidural bolus volume with the dural puncture epidural technique for labour analgesia: a biased-coin up-and-down sequential allocation study. Can J Anaesth. 2025 Feb;72(2):254-261. doi: 10.1007/s12630-024-02855-6. Epub 2024 Oct 21.'}, {'pmid': '37824436', 'type': 'BACKGROUND', 'citation': 'Maeda A, Villela-Franyutti D, Lumbreras-Marquez MI, Murthy A, Fields KG, Justice S, Tsen LC. Labor Analgesia Initiation With Dural Puncture Epidural Versus Conventional Epidural Techniques: A Randomized Biased-Coin Sequential Allocation Trial to Determine the Effective Dose for 90% of Patients of Bupivacaine. Anesth Analg. 2024 Jun 1;138(6):1205-1214. doi: 10.1213/ANE.0000000000006691. Epub 2023 Oct 12.'}]}, 'descriptionModule': {'briefSummary': "This study is being done to determine the most effective dose of medicine to use to initially provide effective pain relief within the first 30 minutes of receiving an epidural for pain labor during labor. The study team will also study any side effects related to the epidural medication and patients' satisfaction with the quality of pain relief after receiving the epidural.", 'detailedDescription': 'We aim to perform a prospective observational study in a single cohort of 50 patients receiving a dural-puncture epidural technique for labor analgesia. We will use a biased-coin up-down allocation methodology to quantify the volume of a combined epidural 0.1% ropivacaine and 2 mcg/ml fentanyl regimen that achieves effective analgesia in 90% of patients experiencing active labor who receive a dural-puncture epidural technique for labor analgesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant birthing patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with singleton vertex pregnancies in active labor (latent or spontaneous labor or after induction of labor)\n* Cervical dilatation between 2 and 7 cm\n* Requesting neuraxial labor analgesia\n* Age 18 or older\n\nExclusion Criteria:\n\n* Significant obstetric disease (e.g., pre-eclampsia, major cardiac disease)\n* Chronic pain or chronic opioid use\n* BMI ≥ 50\n* Multiple gestations\n* Allergy or anaphylaxis to local anesthetic\n* Fetal compromise or non-reassuring fetal trace\n* Age under 18\n* Inability to speak and understand English or Spanish'}, 'identificationModule': {'nctId': 'NCT07076368', 'acronym': 'EV90_DPE', 'briefTitle': 'Ropivacaine and Fentanyl for Labor Epidural Initiation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Determination of the 90% Effective Volume (ED90) of Epidural 0.1% Ropivacaine and Fentanyl for Labor Analgesia Initiation in Patients Receiving a Dural-Puncture Epidural Technique', 'orgStudyIdInfo': {'id': '25-43988'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Observational Cohort', 'description': 'Patients with singleton vertex pregnancies in active labor (spontaneous or after induction of labor), with a cervical dilatation between 1 and 7cm who are requesting neuraxial labor analgesia, Age =\\>18 yrs', 'interventionNames': ['Drug: Ropivacaine + Fentanyl']}], 'interventions': [{'name': 'Ropivacaine + Fentanyl', 'type': 'DRUG', 'description': 'A standard epidural admixture - 0.1% Ropivacaine + 2 mcg/ml fentanyl - will be used.', 'armGroupLabels': ['Observational Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Alexander Butwick, MBBS, FRCA, MS', 'role': 'CONTACT', 'email': 'alexander.butwick@ucsf.edu', 'phone': '415-514-3757'}], 'overallOfficials': [{'name': 'Alexander Butwick, MBBS, FRCA, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}