Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT05543694
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2022-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The biased-coin allocation after each successful response will be implemented by flipping a virtual biased coin (10% vs. 90% probability of randomizing the next patient to the lower vs. same dose than received by the last patient with the same epidural technique) using R statistical software (R Foundation for Statistical Computing, Vienna, Austria). Care Provider (Clinical Anesthesiologist) will administer the identified dose, then summon blinded observer.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial Using Biased Coin Design to Determine Effective Dose for 90% (ED90) of Subjects'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verbal Numerical Pain Rating Score', 'timeFrame': '30 minutes', 'description': '(0-10, with higher scores meaning more pain); goal with analgesia is \\< 3/10'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dural puncture epidural', 'Neuraxial Analgesia', 'Bupivacaine', 'Local Anesthetic'], 'conditions': ['Labor Pain', 'Analgesia']}, 'referencesModule': {'references': [{'pmid': '20613484', 'type': 'BACKGROUND', 'citation': 'Ngan Kee WD, Ng FF, Khaw KS, Lee A, Gin T. Determination and comparison of graded dose-response curves for epidural bupivacaine and ropivacaine for analgesia in laboring nulliparous women. Anesthesiology. 2010 Aug;113(2):445-53. doi: 10.1097/ALN.0b013e3181bdf9da.'}, {'pmid': '14639153', 'type': 'BACKGROUND', 'citation': 'Benhamou D, Ghosh C, Mercier FJ. A randomized sequential allocation study to determine the minimum effective analgesic concentration of levobupivacaine and ropivacaine in patients receiving epidural analgesia for labor. Anesthesiology. 2003 Dec;99(6):1383-6. doi: 10.1097/00000542-200312000-00022.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'To estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor after receiving a lidocaine "test dose"', 'detailedDescription': 'The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; we hypothesize that we will be able to determine the ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses. We will be conducting this study in women who receive a prior lidocaine "test dose" used in standard clinical practice'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parturient with no major co-morbidities\n* Singleton, vertex gestation at term (37-42 weeks)\n* Less than or equal to 5 cm dilation\n* Desire to receive epidural labor analgesia\n* Numerical Rating Scale greater or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.\n\nExclusion Criteria:\n\n* Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)\n* Any contraindication to the administration of an epidural technique\n* History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent\n* Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. history of uterine rupture). NB: Exception-trial of labor after cesarean delivery (TOLAC) will be eligible.\n* Evidence of anticipated fetal anomalies'}, 'identificationModule': {'nctId': 'NCT05543694', 'briefTitle': 'ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'ED90 of Epidural Bupivacaine for the Initiation of Labor Analgesia: A Randomized Biased Coin Sequential Allocation Trial With a Lidocaine Test Dose', 'orgStudyIdInfo': {'id': '2022P002226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dural Puncture Epidural Technique', 'description': 'Laboring women receiving the Dural Puncture Epidural (DPE) Technique, after a lidocaine "test dose", with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the DPE group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \\< 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.', 'interventionNames': ['Drug: Bupivacaine Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural Technique', 'description': 'Laboring women receiving the Conventional Epidural Technique (EPL), after receiving a lidocaine "test dose" with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the EPL group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \\< 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.', 'interventionNames': ['Drug: Bupivacaine Hydrochloride']}], 'interventions': [{'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG', 'description': 'Subjects will receive a dose of bupivacaine as described in the arm section of this trial', 'armGroupLabels': ['Dural Puncture Epidural Technique', 'Epidural Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lawrence C Tsen, MD', 'role': 'CONTACT', 'email': 'ltsen@zeus.bwh.harvard.edu', 'phone': '617-732-8216'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Lawrence C Tsen, MD', 'role': 'CONTACT', 'email': 'ltsen@bwh.harvard.edu', 'phone': '617-732-8216'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesia', 'investigatorFullName': 'Lawrence Ching Tsen', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}