Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 5:49 PM
Study NCT ID:
NCT03414359
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2018-01-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nelsharawi@uams.edu', 'phone': '5016866114', 'title': 'Nadir El Sharawi', 'organization': 'UAMS'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During inpatient admission, approximately three days', 'description': 'local anesthetic systemic toxicity (LAST), post-dural puncture headache (PDPH) and high spinal (defined as upper limb weakness)', 'eventGroups': [{'id': 'EG000', 'title': '2% Lidocaine', 'description': '2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3% Chloroprocaine', 'description': '3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 1, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post dural puncture headache', 'notes': 'presumed post-dural puncture headache due to spinal needle, treated with epidural blood batch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Onset Time to Surgical Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2% Lidocaine', 'description': '2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)'}, {'id': 'OG001', 'title': '3% Chloroprocaine', 'description': '3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)'}], 'classes': [{'categories': [{'measurements': [{'value': '558', 'spread': '269', 'groupId': 'OG000'}, {'value': '655', 'spread': '258', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance is, \\<0.05', 'groupDescription': 'To exclude a clinically important difference between the LEBF group and the chloroprocaine group, given a standard deviation of 4 minutes, and a non-inferiority margin of 3 minutes difference between groups, 62 mother-infant dyads (31 mother-infant dyads in each arm) are required to have a significance level of 5% and a power of 90%. In total, 70 female patients were recruited to account for any withdrawals.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'As there is no existing data in the literature that clearly defines a clinically significant reduction in the onset time of anesthesia, the non-inferiority margin was defined a priori based on clinical reasoning.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 35 minutes', 'description': 'The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2% Lidocaine', 'description': '2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)'}, {'id': 'OG001', 'title': '3% Chloroprocaine', 'description': '3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'This requirement for any rescue medications to control discomfort or pain during CD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2% Lidocaine', 'description': '2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)'}, {'id': 'FG001', 'title': '3% Chloroprocaine', 'description': '3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '2% Lidocaine', 'description': '2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)'}, {'id': 'BG001', 'title': '3% Chloroprocaine', 'description': '3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '32'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '34'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '37'}, {'value': '32', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '37'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000', 'lowerLimit': '273', 'upperLimit': '275'}, {'value': '273', 'groupId': 'BG001', 'lowerLimit': '268', 'upperLimit': '273'}, {'value': '273', 'groupId': 'BG002', 'lowerLimit': '270', 'upperLimit': '274'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Duration of epidural infusion', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '38', 'upperLimit': '73'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '36', 'upperLimit': '70'}, {'value': '49', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-13', 'size': 578068, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-05T13:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2018-01-22', 'resultsFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-30', 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Onset Time to Surgical Anesthesia', 'timeFrame': 'Up to 35 minutes', 'description': 'The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation', 'timeFrame': '1 hour', 'description': 'This requirement for any rescue medications to control discomfort or pain during CD'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Anesthesia, Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '32852294', 'type': 'DERIVED', 'citation': 'Sharawi N, Bansal P, Williams M, Spencer H, Mhyre JM. Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study. Anesth Analg. 2021 Mar 1;132(3):666-675. doi: 10.1213/ANE.0000000000005141.'}]}, 'descriptionModule': {'briefSummary': 'Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event of cesarean delivery, epidural analgesia can be "extended" to provide surgical anesthesia. Numerous studies have been performed to assess the onset times of various local anesthetics when administered through an epidural catheter. Attempts to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been attempted by using different local anesthetic solutions and by the addition of other drugs to the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).', 'detailedDescription': 'Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event of cesarean delivery, epidural analgesia can be "extended" to provide surgical anesthesia. Numerous studies have been performed to assess the onset times of various local anesthetics when administered through an epidural catheter. Attempts to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been attempted by using different local anesthetic solutions and by the addition of other drugs to the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).\n\nA recent meta-analysis concluded that the optimum local anesthetic solution for extending a labor epidural from analgesia to surgical anesthesia has yet to be determined 2. In 1994, a retrospective study compared 1.5% lidocaine/bicarbonate/epinephrine mixture to 3% chloroprocaine in parturients with pre-existing epidural catheters for urgent cesarean delivery3. It was found that the chloroprocaine group had a significantly faster onset of anesthesia compared to the lidocaine group. Both drugs provided excellent anesthesia. However a high quality study comparing 3% chloroprocaine with 2% lidocaine/ epinephrine/ bicarbonate/ fentanyl (LEBF) in terms of anesthetic onset times has yet to be performed.\n\nWomen in labor frequently request an epidural to provide pain relief. Epidural pain relief is commonly provided by the administration of a low concentration of local anesthetic and opioid solution through an epidural catheter. This solution is delivered by an automated epidural infusion pump. In the event that a cesarean delivery is required, the pre-existing epidural is frequently used to administer a higher concentration anesthetic solution to allow pain free cesarean delivery. This is commonly referred to as an "epidural top up" or as an "extension of the epidural block." Standard practice at University of Arkansas for Medical Sciences (UAMS) for an epidural top up is Lidocaine, Epinephrine, Bicarbonate and Fentanyl (LEBF) or 3% chloroprocaine. These two mixtures are routinely and almost exclusively used for epidural cesarean delivery. The decision on which mixture to use is based solely on physician preference. It is likely that the LBEF mixture is used more frequently but the investigators consider both local anesthetic mixtures as equals and the standard of care at UAMS. The investigators do not use any other local anesthetics (unless there are very specific reasons).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Any mother requiring an elective cesarean section.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age for the mother\n* Singleton pregnancy\n* Gestation \\> 36 weeks\n* American Society of Anesthesiologist (ASA) class II\n* Provides written consent\n* Infant of mother\n\nExclusion Criteria:\n\n* Patient refusal\n* Non-elective or urgent/emergent cesarean sections\n* ASA class III or above\n* Unable to understand English\n* Significant back surgery or scoliosis\n* Known fetal abnormality\n* Weight \\> 120 kg\n* Height \\< 150 cm\n* Allergy to local anesthetics\n* Concurrent use of sulfonamides'}, 'identificationModule': {'nctId': 'NCT03414359', 'briefTitle': 'Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'A Randomized, Double-blind Study Comparing 3% Chloroprocaine Versus 2 % Lidocaine/ Epinephrine/ Bicarbonate/ Fentanyl for Epidural Anesthesia in Elective Cesarean Delivery', 'orgStudyIdInfo': {'id': '207313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2% Lidocaine', 'description': 'Group LEBF received 20 ml of 2% lidocaine (combined with the following adjuncts \\[0.15 ml of 0.1% epinephrine, 2 ml of 8.4% sodium bicarbonate and 2 ml of 100 mcg fentanyl', 'interventionNames': ['Drug: 2% Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': '3% Chloroprocaine', 'description': '20 ml of 3% chloroprocaine with 4 ml 0.9% sodium chloride', 'interventionNames': ['Drug: 3% Chloroprocaine']}], 'interventions': [{'name': '2% Lidocaine', 'type': 'DRUG', 'otherNames': ['Xylocaine'], 'description': '2% Lidocaine using a combined spinal-epidural (CSE)', 'armGroupLabels': ['2% Lidocaine']}, {'name': '3% Chloroprocaine', 'type': 'DRUG', 'otherNames': ['Nesacaine'], 'description': '3% Chloroprocaine using a combined spinal-epidural (CSE)', 'armGroupLabels': ['3% Chloroprocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Nadir Sharawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}