Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT02152293
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2014-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Chloroprocaine (CLOROTEKAL®) on Eligibility for Discharge From Hospital After Outpatient Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 620}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2014-05-23', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of CLOROTEKAL® on the discharge from hospital', 'timeFrame': 'Average time expected around 180 min after the surgery (Lacasse, 2011)', 'description': 'Time to eligibility for discharge from hospital measured as the time between the intrathecal injection and achieving the criteria of Lacasse.\n\nThis period will be described globally (average time) and by groups: \\<180 min ; \\<240 min ; \\<300 min ; \\<360 min ; \\> 360 min.'}], 'secondaryOutcomes': [{'measure': 'Modalities of spinal anesthesia with CLOROTEKAL®', 'timeFrame': 'During surgery'}, {'measure': 'Safety of CLOROTEKAL', 'timeFrame': 'Up to 24 hours after surgery', 'description': 'Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with chloroprocaine.'}, {'measure': "Patients' satisfaction", 'timeFrame': '24h after surgery'}, {'measure': 'Postoperative patients pain', 'timeFrame': 'During the 24 hours following surgery'}, {'measure': 'Rate of unplanned admissions related to anesthesia and/or surgery', 'timeFrame': 'Within the same day than surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Anesthesia', 'Outpatient Surgery']}, 'referencesModule': {'references': [{'pmid': '21203878', 'type': 'BACKGROUND', 'citation': 'Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.'}, {'pmid': '31828611', 'type': 'DERIVED', 'citation': 'Capdevila X, Aveline C, Delaunay L, Bouaziz H, Zetlaoui P, Choquet O, Jouffroy L, Herman-Demars H, Bonnet F. Impact of Chloroprocaine on the Eligibility for Hospital Discharge in Patients Requiring Ambulatory Surgery Under Spinal Anesthesia: An Observational Multicenter Prospective Study. Adv Ther. 2020 Jan;37(1):541-551. doi: 10.1007/s12325-019-01172-5. Epub 2019 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess, in real life, the efficacy and the eligibility for discharge of a local anesthetic, CLOROTEKAL®, used for spinal anesthesia in short outpatient surgery.', 'detailedDescription': "This is a longitudinal, observational, prospective, multicentre, national study, conducted in France, from a representative sample of physician anesthetists.\n\nThe efficacy and safety in real life of CLOROTEKAL® will be assessed in patients undergoing a short outpatient surgery under spinal anesthesia. Data will be collected by the physician during two visits (pre-anesthesia and per-postoperative consultation). Additional data regarding the patient's perception (safety, pain and satisfaction) will be collected using a self-questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for surgery under spinal anesthesia of short duration will be informed about the study and will be asked to participate, from about day -14 (pre-anesthesia consultation) to 24h after the day of surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients seen in pre-anesthesia consultation for ambulatory surgery\n* Patients for whom a spinal anesthesia using CLOROTEKAL® is planned\n* Patients accepting and able to complete a satisfaction self-administered questionnaire\n* Informed patients who accept the computer processing of their medical data and their right of access and correction\n\nExclusion Criteria:\n\n* Patients with contra-indications to spinal anesthesia (eg decompensated cardiac insufficiency, hypovolemic shock….)\n* Patients with contra-indications to chloroprocaine (hypersensitivity to the active substance, medicinal products of the para-aminobenzoic acid ester group, other ester-type local anaesthetics or to any of the excipients ; Intravenous regional anaesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area), serious problems with cardiac conduction, severe anemia)\n* Patients participating or having participated in the previous month in a clinical trial in anesthesiology'}, 'identificationModule': {'nctId': 'NCT02152293', 'acronym': 'CLOCK', 'briefTitle': 'Impact of Chloroprocaine (CLOROTEKAL®) on Eligibility for Discharge From Hospital After Outpatient Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordic Pharma SAS'}, 'officialTitle': 'Pharmacoepidemiology Study on Real Life Impact of Chloroprocaine (CLOROTEKAL®) on the Eligibility for Discharge From Hospital of Patients Requiring Short Outpatient Surgery Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'CLOCK'}}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Nordic Pharma', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Hélène HERMAN-DEMARS, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nordic Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordic Pharma SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}