Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT02387060
Status:
UNKNOWN
Last Update Posted:
2015-03-12
First Post:
2015-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-07', 'studyFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2015-03-07', 'lastUpdatePostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Punctate - Von frey (grams)', 'timeFrame': 'Change from Baseline in punctate sensibility at 48 hours'}], 'secondaryOutcomes': [{'measure': 'Change in Pressure pain - algometer (kg/cm/cm)', 'timeFrame': 'Change from Baseline in pressure pain at 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Spinal and Epidural', 'Adverse Effect', 'Complications'], 'conditions': ['Complications; Cesarean Section']}, 'descriptionModule': {'briefSummary': 'Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly effective, their use is not without problems. One is the increasing requirement of these address the same nociceptive stimulus.\n\nOpioid induced hyperalgesia could be an explanation studies in animal models. Through mechanisms where N-methyl-D-aspartate receptors, glutamatergic system disturbances and changes in intracellular calcium regulation involved.\n\nThe hyperalgesia induced by intrathecal opioids is controversial. The investigators propose a model study in patients undergoing cesarean section to study the secondary hyperalgesia induced based on the study of nociceptive thresholds with two methods opioids: Von Frey filaments and digital algometer.\n\nIf intrathecal fentanyl is used in spinal anesthesia for elective cesarean section, then, an increase in sensitivity will occur. This increase can be measured by von Frey filaments, expressed in increased requirement clinically opioids.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant 37 to 41 weeks.\n* American Society of Anesthesiologists classificationI or II.\n* Between 18 and 40 years.\n* Scheduled for elective cesarean section under spinal anesthesia in the Maternity Service of the Clinical Hospital of the Catholic University.\n\nExclusion Criteria:\n\n* Background Of high risk pregnancy. Twin-pregnancy.\n* Obesity\\> 30 kg / m 2 before pregnancy.\n* Background Of psychiatric illness.\n* Using Chronic analgesic.\n* AllergyDrug used in protocol.\n* require General anesthesia during surgery'}, 'identificationModule': {'nctId': 'NCT02387060', 'briefTitle': 'Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean', 'orgStudyIdInfo': {'id': '13-389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'H-Bupivacaine 11.5 mg + fentanyl 25 mcg.', 'description': 'Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg.', 'interventionNames': ['Drug: H-Bupivacaine', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'H-Bupivacaine 11.5 mg.', 'description': 'Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75%', 'interventionNames': ['Drug: H-Bupivacaine']}], 'interventions': [{'name': 'H-Bupivacaine', 'type': 'DRUG', 'otherNames': ['Hyperbaric bupivacaine'], 'description': 'Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%', 'armGroupLabels': ['H-Bupivacaine 11.5 mg + fentanyl 25 mcg.', 'H-Bupivacaine 11.5 mg.']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Intrathecal administration of fentanyl 25 mcg', 'armGroupLabels': ['H-Bupivacaine 11.5 mg + fentanyl 25 mcg.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8330024', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Hernan Auad, MD', 'role': 'CONTACT', 'email': 'hernan_auad@hotmail.com', 'phone': '56982933226'}, {'name': 'Juan Carlos de la Cuadra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clinico Pontificia Universidad Catolica', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Juan Carlos De la Cuadra, MD', 'role': 'CONTACT', 'email': 'juancarl@med.puc.cl', 'phone': '+56-2-23543270'}, {'name': 'Hernan Auad, MD', 'role': 'CONTACT', 'email': 'hernan_auad@hotmail.com', 'phone': '+56-2-23543270'}], 'overallOfficials': [{'name': 'Luis I Cortinez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ponticia Universidad Católica'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}