protocolSection identificationModule nctId: NCT06376058, orgStudyIdInfo id: 434/06-06-2022, briefTitle: Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section, acronym: annie-mariana, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2026-01-10, completionDateStruct date: 2026-01-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Aretaieion University Hospital, class: OTHER, descriptionModule briefSummary: This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections, conditionsModule conditions: Cesarean Section, conditions: Local Anesthetic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Chloroprocaine 1% Injectable Solution, interventions name: Ropivacaine 0.75% Injectable Solution, outcomesModule primaryOutcomes measure: Time from spinal anesthesia to T10 block (min), primaryOutcomes measure: Time from spinal anesthesia to T4 block (min), primaryOutcomes measure: Time of spinal anesthesia to Bromage =3, primaryOutcomes measure: level of sensory block every 3 min, primaryOutcomes measure: level of sensory block every 15 min, primaryOutcomes measure: highest level of sensory block, primaryOutcomes measure: time from spinal anesthesia to highest level of sensory block, primaryOutcomes measure: duration of sensory block, primaryOutcomes measure: pain at surgical incision, primaryOutcomes measure: pain at neonatal delivery, primaryOutcomes measure: pain at peritoneal manipulation, primaryOutcomes measure: pain at Post Anesthesia Care Unit (PACU) admission, primaryOutcomes measure: pain at Post Anesthesia Care Unit (PACU) discharge, primaryOutcomes measure: need for rescue analgesia intraoperatively, primaryOutcomes measure: Bromage scale every 3 min after spinal anesthesia, primaryOutcomes measure: Bromage scale every 15 min, primaryOutcomes measure: duration of motor block, primaryOutcomes measure: duration of staying in PACU, secondaryOutcomes measure: Neonatal Apgar score at 1 minute, secondaryOutcomes measure: Neonatal Apgar score at 5 minutes, secondaryOutcomes measure: neonatal blood gases, secondaryOutcomes measure: incidence of neonatal acidosis, secondaryOutcomes measure: incidence of hypotension, secondaryOutcomes measure: incidence of bradycardia, secondaryOutcomes measure: need for vasoconstrictor, secondaryOutcomes measure: need for atropine, secondaryOutcomes measure: incidence of nausea/vomiting, secondaryOutcomes measure: incidence of dizziness, secondaryOutcomes measure: incidence of drowsiness, secondaryOutcomes measure: incidence of discomfort, secondaryOutcomes measure: incidence of shivering, secondaryOutcomes measure: need for rescue analgesia in PACU, secondaryOutcomes measure: time from spinal anesthesia to rescue analgesia in PACU, secondaryOutcomes measure: incidence of neurological symptoms during hospital stay, secondaryOutcomes measure: incidence of neurological symptoms 2 months after the operation, secondaryOutcomes measure: incidence of low back pain, secondaryOutcomes measure: time from spinal anesthesia to mobilization, secondaryOutcomes measure: mother's satisfaction from anesthesia, secondaryOutcomes measure: gynecologist's satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 48 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aretaieion University Hospital, status: RECRUITING, city: Athens, zip: 11528, country: Greece, contacts name: Kassiani Theodoraki, PhD, DESA, role: CONTACT, phone: 6974634162, email: ktheodoraki@hotmail.com, contacts name: Marianna Mavromati, MD, role: CONTACT, email: marimavr14@gmail.com, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False