Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-19 @ 6:51 PM
Study NCT ID:
NCT03110003
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2017-03-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bupivacaine With Epidural Volume Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mfpowell@uabmc.edu', 'phone': '205-975-3328', 'title': 'Dr. Mark Powell', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Until PACU Discharge in Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space'}, {'id': 'OG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '103', 'upperLimit': '182.5'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '57.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 48 hrs postoperatively', 'description': 'Time from entrance into the PACU until PACU discharge criteria met', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Block Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space'}, {'id': 'OG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7.5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '7.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 3 hours', 'description': 'Thoracic dermatome level as assessed by pinprick', 'unitOfMeasure': 'Thoracic dermatome', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Thoracic dermatome level as assessed by pinprick'}, {'type': 'SECONDARY', 'title': 'Degree of Peak Motor Blockade by Modified Bromage Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space'}, {'id': 'OG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 3 hours', 'description': "Motor blockade will be determined by the patient's ability to lift her legs\n\nThis is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space'}, {'id': 'OG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '225.5'}, {'value': '66', 'groupId': 'OG001', 'lowerLimit': '44.5', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 6 hours', 'description': "Time until score of \\<2 reached on Modified Bromage scale\n\nThis is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs. Once the patient received as score of 0, the time ended. Again, 0=ability to maintain a leg lift for prolonged periods.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Time elapsed until motor block regresses to modified Bromage = 0.'}, {'type': 'SECONDARY', 'title': 'Quality of Block as Determined by Subjective Pain Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space'}, {'id': 'OG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.'}], 'timeFrame': 'Baseline up to 6 hours', 'description': 'Determined by any pain reported during surgery and/or the need to supplement through the epidural', 'reportingStatus': 'POSTED', 'populationDescription': 'Quality of Block as determined by subjective pain assessment was not collected by the investigators.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction as Determined by a Likert-type Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space'}, {'id': 'OG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.'}], 'timeFrame': 'At 6 hrs postoperatively', 'description': 'Patient satisfaction of a scale of 1-10\n\nThis scale is grade from 1 to 10 with 1 being "highly dissatisfied" with the anesthetic technique and 10 being "highly satisfied." Each patient was asked to rate their experience with the anesthetic technique provide. They could choose any number between 1 and 10. Numbers close to 10 represented a higher satisfaction with the anesthetic technique.', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient satisfaction as determined by a Likert-type scale was not collected by the investigators.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space'}, {'id': 'FG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.\n\n10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space'}, {'id': 'BG001', 'title': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.\n\n5 mg Bupivacaine: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], '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': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', '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': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', '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 and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-25', 'size': 6363643, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-06T10:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2017-03-30', 'resultsFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-06', 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Until PACU Discharge in Minutes', 'timeFrame': 'Baseline up to 48 hrs postoperatively', 'description': 'Time from entrance into the PACU until PACU discharge criteria met'}], 'secondaryOutcomes': [{'measure': 'Peak Block Height', 'timeFrame': 'Baseline up to 3 hours', 'description': 'Thoracic dermatome level as assessed by pinprick'}, {'measure': 'Degree of Peak Motor Blockade by Modified Bromage Scale', 'timeFrame': 'Baseline up to 3 hours', 'description': "Motor blockade will be determined by the patient's ability to lift her legs\n\nThis is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs."}, {'measure': 'Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0', 'timeFrame': 'Baseline up to 6 hours', 'description': "Time until score of \\<2 reached on Modified Bromage scale\n\nThis is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs. Once the patient received as score of 0, the time ended. Again, 0=ability to maintain a leg lift for prolonged periods."}, {'measure': 'Quality of Block as Determined by Subjective Pain Assessment', 'timeFrame': 'Baseline up to 6 hours', 'description': 'Determined by any pain reported during surgery and/or the need to supplement through the epidural'}, {'measure': 'Patient Satisfaction as Determined by a Likert-type Scale', 'timeFrame': 'At 6 hrs postoperatively', 'description': 'Patient satisfaction of a scale of 1-10\n\nThis scale is grade from 1 to 10 with 1 being "highly dissatisfied" with the anesthetic technique and 10 being "highly satisfied." Each patient was asked to rate their experience with the anesthetic technique provide. They could choose any number between 1 and 10. Numbers close to 10 represented a higher satisfaction with the anesthetic technique.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuraxial epidural techniques', 'Combined spinal epidural', 'Epidural volume extension', 'Transient Neurologic Symptoms (TNS)'], 'conditions': ['Spinal Anesthesia', 'Epidural; Anesthesia']}, 'descriptionModule': {'briefSummary': 'In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.', 'detailedDescription': 'Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.\n\nExclusion Criteria:\n\n* coagulopathy\n* platelets \\<80,000\n* allergy to local anesthetic or fentanyl\n* previous spinal surgery\n* spinal or intracranial mass\n* history of lower extremity weakness'}, 'identificationModule': {'nctId': 'NCT03110003', 'briefTitle': 'Bupivacaine With Epidural Volume Extension', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Comparing Low-dose Bupivacaine With Epidural Volume Extension to Standard Bupivacaine Dosing for Short Obstetric Procedures: A Prospective, Randomized Study', 'orgStudyIdInfo': {'id': 'F1605020005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10 mg Bupivacaine', 'description': 'Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.', 'interventionNames': ['Drug: 10 mg Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5 mg Bupivacaine', 'description': 'Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.', 'interventionNames': ['Drug: 5 mg Bupivacaine']}], 'interventions': [{'name': '10 mg Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine and Sensorcaine'], 'description': '10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space', 'armGroupLabels': ['10 mg Bupivacaine']}, {'name': '5 mg Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine and Sensorcaine'], 'description': '5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.', 'armGroupLabels': ['5 mg Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Department of Anesthesiology and Perioperative Medicine', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Mark Powell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mark Powell', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}