Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-13 @ 4:14 PM
Study NCT ID:
NCT02150161
Status:
TERMINATED
Last Update Posted:
2015-09-25
First Post:
2014-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D005283', 'term': 'Fentanyl'}], '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': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'whyStopped': 'DSMB estimated futility of the trial and safety risk', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2014-05-26', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting in the recovery room', 'timeFrame': 'first 3 postoperative hours'}, {'measure': 'morphine consumption in the recovery room', 'timeFrame': 'first 3 postopeartive hours'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting on day 1', 'timeFrame': '1st postoperative day'}, {'measure': 'Anesthestic gas consumption', 'timeFrame': 'intraoperative'}]}, 'conditionsModule': {'conditions': ['Opioid Free Anaesthesia', 'Postoperative Analgesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* ASA I-II\n* Undergoing elective hip arthroscopy\n\nExclusion Criteria:\n\n* Known allergies to study drugs\n* Opioid use 1 month prior to surgery\n* BMI \\>30\n* Unable to comprehend visual analog scale'}, 'identificationModule': {'nctId': 'NCT02150161', 'briefTitle': 'Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Santa Maria'}, 'officialTitle': 'Fentanyl vs. Lidocaine/Ketamine Infusion for Hip Arthroscopy', 'orgStudyIdInfo': {'id': '56csm2014001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine/ ketamine infusion', 'description': 'lidocaine 1mg/Kg bolus, followed by continuous infusion 1 mg/kg/h AND ketamine 1mg/Kg bolus followed by continuous infusion 1 mg/kg/h', 'interventionNames': ['Drug: Lidocaine/ ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl', 'description': 'iv fentanyl, 3ug/kg bolus', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Lidocaine/ ketamine', 'type': 'DRUG', 'armGroupLabels': ['lidocaine/ ketamine infusion']}, {'name': 'Fentanyl', 'type': 'DRUG', 'armGroupLabels': ['fentanyl']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'facility': 'Clinica Santa Maria', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'David Torres, MD; MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Santa Maria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Santa Maria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'David Torres', 'investigatorAffiliation': 'Clinica Santa Maria'}}}}