Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 2:18 AM
Study NCT ID:
NCT04369950
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2020-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'C004616', 'term': 'chloroprocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Linden.O.Lee@uth.tmc.edu', 'phone': '(713) 500-6200', 'title': 'Linden Lee, MD, Assistant Professor', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'No prior studies investigating the technique studied in order to calculate study size; wide interindividual differences in pain; physician administering epidural medications not blinded; originally intended to recruit 80, but due to recruitment challenges decided to modify recruitment goal to about 40 and classify this as an exploratory study'}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': '2 Percent Lidocaine With Epinephrine and Epidural Morphine', 'description': '2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3 Percent 2-Chloroprocaine and Epidural Morphine', 'description': '3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. 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T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.'}, {'id': 'OG001', 'title': '3 Percent 2-Chloroprocaine and Epidural Morphine', 'description': '3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. 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T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.'}, {'id': 'OG001', 'title': '3 Percent 2-Chloroprocaine and Epidural Morphine', 'description': '3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. 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T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.'}, {'id': 'OG001', 'title': '3 Percent 2-Chloroprocaine and Epidural Morphine', 'description': '3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. 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T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.'}, {'id': 'OG001', 'title': '3 Percent 2-Chloroprocaine and Epidural Morphine', 'description': '3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. 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T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.'}, {'id': 'OG001', 'title': '3 Percent 2-Chloroprocaine and Epidural Morphine', 'description': '3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. 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T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.'}, {'id': 'OG001', 'title': '3 Percent 2-Chloroprocaine and Epidural Morphine', 'description': '3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. 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'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '159.5', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '163', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '161.25', 'spread': '7.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '84.0', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '87.1', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '85.55', 'spread': '14.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '32.4', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '32.35', 'spread': '4.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants who Smoke', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '38.65', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gravida', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pregnancies', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Para', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'description': 'number of completed pregnancies beyond 20 weeks gestation (whether viable or nonviable)', 'unitOfMeasure': 'completed pregnancies', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Duration of labor analgesia', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '7.9', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '5.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Surgical duration', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '52'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '35.5', 'upperLimit': '57.5'}, {'value': '38.5', 'groupId': 'BG002', 'lowerLimit': '30.5', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of participants who received a labor analgesia with combined spinal epidural', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Prior Cesarean Delivery / trial of labor after cesarean', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgical Complication (uterine artery laceration and postpartum hemorrhage)', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-04', 'size': 427826, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-18T12:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2020-04-27', 'resultsFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-28', 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Amount of Opioid Used', 'timeFrame': '24 hours after epidural morphine administration'}], 'secondaryOutcomes': [{'measure': 'Total Amount of Opioid Used', 'timeFrame': '12 hours after epidural morphine administration'}, {'measure': 'Total Amount of Opioid Used', 'timeFrame': '8 hours after epidural morphine administration'}, {'measure': 'Total Amount of Opioid Used', 'timeFrame': '4 hours after epidural morphine administration'}, {'measure': 'Pain as Measured by a 11 Point Verbal Scale', 'timeFrame': '4,8, 12 and 24 hours after epidural morphine administration', 'description': 'scale ranges form 0-10, higher number indicating more pain'}, {'measure': 'Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale', 'timeFrame': '4,8, 12 and 24 hours after epidural morphine administration', 'description': 'scale ranges from non,mild and moderate-severe'}, {'measure': 'Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale', 'timeFrame': '4,8, 12 and 24 hours after epidural morphine administration', 'description': 'scale ranges from non,mild and moderate-severe'}, {'measure': 'Time Until First Opioid Request', 'timeFrame': 'Up to 48 hours after epidural morphine administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean delivery', 'c-section', 'chloroprocaine', 'lidocaine', 'morphine', 'post-operative pain', 'post-cesarean analgesia'], 'conditions': ['Physiological Effect of Drugs', 'Morphine', 'Analgesics', 'Analgesics, Opioid', 'Central Nervous System Depressants', 'Narcotics']}, 'referencesModule': {'references': [{'pmid': '36534717', 'type': 'DERIVED', 'citation': 'Lee LO, Ramirez-Chapman AL, White DL, Zhang X, Lu M, Suresh MS. Postcesarean Analgesia With Epidural Morphine After Epidural 2-Chloroprocaine: A Randomized Noninferiority Trial. Anesth Analg. 2023 Jan 1;136(1):86-93. doi: 10.1213/ANE.0000000000006109. Epub 2022 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant patients\n* live singleton pregnancy\n\nExclusion Criteria:\n\n* BMI \\>40\n* obstructive sleep apnea\n* drug abuse\n* chronic pain\n* chronic opioid use\n* nonfunctioning epidural'}, 'identificationModule': {'nctId': 'NCT04369950', 'briefTitle': 'Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine', 'orgStudyIdInfo': {'id': 'HSC-MS-19-0951'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2 percent Lidocaine with epinephrine and epidural morphine', 'interventionNames': ['Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine']}, {'type': 'EXPERIMENTAL', 'label': '3 percent 2-Chloroprocaine and epidural morphine', 'interventionNames': ['Drug: 3% 2-chloroprocaine and epidural morphine']}], 'interventions': [{'name': '2% lidocaine with 1:200,000 epinephrine and epidural morphine', 'type': 'DRUG', 'description': 'Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.', 'armGroupLabels': ['2 percent Lidocaine with epinephrine and epidural morphine']}, {'name': '3% 2-chloroprocaine and epidural morphine', 'type': 'DRUG', 'description': 'Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.', 'armGroupLabels': ['3 percent 2-Chloroprocaine and epidural morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Linden Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Linden Lee', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}