Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-04 @ 9:36 PM
Study NCT ID:
NCT02666794
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2015-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasmatic Catecholamines: Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-04', 'studyFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2016-01-24', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain scores', 'timeFrame': '20 minutes after analgesia (measures every 5 minutes)'}, {'measure': 'APGAR score', 'timeFrame': 'At birth'}, {'measure': 'Fetal acidosis', 'timeFrame': 'At birth', 'description': 'umbilical arterial blood'}], 'primaryOutcomes': [{'measure': 'Cathecolamines levels', 'timeFrame': 'at the moment of analgesia and 20 minutes after', 'description': 'Pattern of cathecolamines levels'}, {'measure': 'Fetal bradycardia', 'timeFrame': '15 minutes before analgesia and 30 minutes after continuously', 'description': 'Fetal bradycardia is defined as the baseline drops to less than 100 bpm'}, {'measure': 'Increase in uterine tone', 'timeFrame': '15 minutes before analgesia and 30 minutes after continuously', 'description': 'Increase in uterine tone (qualitative measure)'}], 'secondaryOutcomes': [{'measure': 'Maternal hipotension', 'timeFrame': '30 minutes after analgesia (measures every 5 minutes)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['analgesia', 'fetal bradycardia', 'hypertonic uterine'], 'conditions': ['Fetal Bradycardia', 'Hypertonic Uterine', 'Catecholamines']}, 'referencesModule': {'references': [{'pmid': '20205623', 'type': 'BACKGROUND', 'citation': 'Baschat AA. Fetal growth restriction - from observation to intervention. J Perinat Med. 2010 May;38(3):239-46. doi: 10.1515/jpm.2010.041.'}, {'pmid': '19104358', 'type': 'RESULT', 'citation': 'Abrao KC, Francisco RPV, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):41-47. doi: 10.1097/AOG.0b013e31818f5eb6.'}, {'pmid': '11359226', 'type': 'RESULT', 'citation': 'Van de Velde M, Vercauteren M, Vandermeersch E. Fetal heart rate abnormalities after regional analgesia for labor pain: the effect of intrathecal opioids. Reg Anesth Pain Med. 2001 May-Jun;26(3):257-62. doi: 10.1053/rapm.2001.22258.'}, {'pmid': '8831313', 'type': 'RESULT', 'citation': 'Nielsen PE, Erickson JR, Abouleish EI, Perriatt S, Sheppard C. Fetal heart rate changes after intrathecal sufentanil or epidural bupivacaine for labor analgesia: incidence and clinical significance. Anesth Analg. 1996 Oct;83(4):742-6. doi: 10.1097/00000539-199610000-00014.'}, {'pmid': '7760614', 'type': 'RESULT', 'citation': 'Collis RE, Davies DW, Aveling W. Randomised comparison of combined spinal-epidural and standard epidural analgesia in labour. Lancet. 1995 Jun 3;345(8962):1413-6. doi: 10.1016/s0140-6736(95)92602-x.'}, {'pmid': '19750306', 'type': 'RESULT', 'citation': 'Nakamura G, Ganem EM, Rugolo LM, Castiglia YM. Effects on mother and fetus of epidural and combined spinal-epidural techniques for labor analgesia. Rev Assoc Med Bras (1992). 2009 Jul-Aug;55(4):405-9. doi: 10.1590/s0104-42302009000400014.'}, {'pmid': '24738803', 'type': 'RESULT', 'citation': 'Patel NP, El-Wahab N, Fernando R, Wilson S, Robson SC, Columb MO, Lyons GR. Fetal effects of combined spinal-epidural vs epidural labour analgesia: a prospective, randomised double-blind study. Anaesthesia. 2014 May;69(5):458-67. doi: 10.1111/anae.12602.'}, {'pmid': '23076897', 'type': 'RESULT', 'citation': 'Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Combined spinal-epidural (CSE) for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, possibly due to asymmetric decrease in catecholamine levels, when compared with epidural analgesia (EP).', 'detailedDescription': 'Background: Combined spinal-epidural technique for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, when compared with epidural analgesia, possibly due to asymmetric decrease in catecholamine levels (epinephrine and norepinephrine) following neuraxial block. However, there are no studies comparing plasmatic catecholamine levels between those two techniques. This study aimed to compare spinal-epidural versus epidural regarding pre and post-analgesia catecholamine levels, uterine tone and fetal heart rate.\n\nMethods: Randomized clinical trial with 47 laboring patients divided in two groups. Primary outcome was plasmatic catecholamine measurements before and after neuraxial block. Secondary outcomes were fetal heart rate changes, uterine hypertonia, hypotension episodes, pain relief and fetal outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParturients aged over 18 years were included when they requested labor analgesia. The inclusion criteria were: patients between 37 and 42 gestational weeks, single pregnancy, in active labor (induced or spontaneous), requesting analgesia with 7 cm or less of cervical dilation. As it is a center that attends only high-risk pregnancies, ASA II or III\n\nExclusion Criteria:\n\nContraindications to interventions, either due to severe comorbidity or contraindication to neuraxial block; previous use of systemic opioids during labor, maternal amniotic infection or known fetal diseases'}, 'identificationModule': {'nctId': 'NCT02666794', 'briefTitle': 'Plasmatic Catecholamines: Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Plasmatic Catecholamines After Neuraxial Labor Analgesia: a Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural', 'orgStudyIdInfo': {'id': '45992815000000068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Puncture epidural', 'description': 'Women in labor the epidural group will receive epidural bupivacaine with vasoconstrictor 0.125% 10 ml plus 20 micrograms sufentanil, followed by the placement of the epidural catheter', 'interventionNames': ['Drug: Epidural bupivacaine with vasoconstrictor 0.125%', 'Drug: Epidural sufentanil', 'Procedure: Placement of the epidural catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Puncture combined spinal-epidural', 'description': 'The mothers of the combined spinal-epidural analgesia group will receive intrathecal hyperbaric bupivacaine solution 0.5% 2.5 mg plus 5.0 micrograms of sufentanil and plus 60 micrograms of morphine, followed by placement of an epidural catheter to the catheter through technical needle', 'interventionNames': ['Drug: Intrathecal hyperbaric bupivacaine solution 0.5%', 'Drug: Intrathecal morphine', 'Procedure: Placement of an epidural catheter to the catheter through technical needle', 'Drug: Intrathecal sufentanil']}], 'interventions': [{'name': 'Epidural bupivacaine with vasoconstrictor 0.125%', 'type': 'DRUG', 'description': '10 ml', 'armGroupLabels': ['Puncture epidural']}, {'name': 'Epidural sufentanil', 'type': 'DRUG', 'description': '20 mcg', 'armGroupLabels': ['Puncture epidural']}, {'name': 'Placement of the epidural catheter', 'type': 'PROCEDURE', 'description': 'Placement of the epidural catheter', 'armGroupLabels': ['Puncture epidural']}, {'name': 'Intrathecal hyperbaric bupivacaine solution 0.5%', 'type': 'DRUG', 'description': '2.5 mg', 'armGroupLabels': ['Puncture combined spinal-epidural']}, {'name': 'Intrathecal morphine', 'type': 'DRUG', 'description': '60 mcg', 'armGroupLabels': ['Puncture combined spinal-epidural']}, {'name': 'Placement of an epidural catheter to the catheter through technical needle', 'type': 'PROCEDURE', 'description': 'Placement of an epidural catheter to the catheter through technical needle', 'armGroupLabels': ['Puncture combined spinal-epidural']}, {'name': 'Intrathecal sufentanil', 'type': 'DRUG', 'description': '5 mcg', 'armGroupLabels': ['Puncture combined spinal-epidural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05408000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Shirley Andrade Santos', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Shirley Santos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'SHIRLEY ANDRADE SANTOS', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}