Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT06376058
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2024-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004616', 'term': 'chloroprocaine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from spinal anesthesia to T10 block (min)', 'timeFrame': 'intraoperative', 'description': 'time required from spinal anesthetic injection to anesthetic block up to the 10th thoracic neurotome'}, {'measure': 'Time from spinal anesthesia to T4 block (min)', 'timeFrame': 'intraoperative', 'description': 'time required from spinal anesthetic injection to anesthetic block up to the 4th thoracic neurotome'}, {'measure': 'Time of spinal anesthesia to Bromage =3', 'timeFrame': 'intraoperative', 'description': 'time required from spinal anesthetic injection to complete motor block (Bromage scale=3, where Bromage=0, no block; Bromage=1, partial block; Bromage=2, almost complete block; Bromage=3, complete block'}, {'measure': 'level of sensory block every 3 min', 'timeFrame': 'intraoperative', 'description': 'measurement of sensory block every 3 minutes after spinal anesthesia during the first 15 minutes'}, {'measure': 'level of sensory block every 15 min', 'timeFrame': 'intraoperative', 'description': 'measurement of sensory block every 15 minutes from spinal anesthesia to the end of the surgery'}, {'measure': 'highest level of sensory block', 'timeFrame': 'intraoperative', 'description': 'measurement of the highest level of sensory block after intrathecal infusion of local anesthetic'}, {'measure': 'time from spinal anesthesia to highest level of sensory block', 'timeFrame': 'intraoperative', 'description': 'time from the performance of spinal anesthesia to the highest level of sensory block'}, {'measure': 'duration of sensory block', 'timeFrame': 'intraoperative', 'description': 'measurement of time required for the sensory block to regress from sensory level T4 to sensory level T12/L2'}, {'measure': 'pain at surgical incision', 'timeFrame': 'intraoperative', 'description': 'pain at skin incision using Visual Analogue Scale (VAS), where VAS=0, no pain; VAS=10, worst pain imaginable'}, {'measure': 'pain at neonatal delivery', 'timeFrame': 'intraoperative', 'description': 'pain at neonatal delivery using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable'}, {'measure': 'pain at peritoneal manipulation', 'timeFrame': 'intraoperative', 'description': 'pain at peritoneal manipulation using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable'}, {'measure': 'pain at Post Anesthesia Care Unit (PACU) admission', 'timeFrame': '1 hour postoperatively', 'description': 'pain at Post Anesthesia Care Unit (PACU) admission using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable'}, {'measure': 'pain at Post Anesthesia Care Unit (PACU) discharge', 'timeFrame': '1 hour postoperatively', 'description': 'pain at Post Anesthesia Care Unit (PACU) discharge using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable'}, {'measure': 'need for rescue analgesia intraoperatively', 'timeFrame': 'intraoperative', 'description': 'need for rescue analgesia during the operation, via epidural catheter or intravenously'}, {'measure': 'Bromage scale every 3 min after spinal anesthesia', 'timeFrame': 'intraoperative', 'description': 'measurement of bromage scale every 3 minutes after spinal anesthesia during the first 15 minutes'}, {'measure': 'Bromage scale every 15 min', 'timeFrame': 'intraoperative', 'description': 'measurement of bromage scale every 15 minutes from spinal anesthesia to the end of the surgery'}, {'measure': 'duration of motor block', 'timeFrame': '1 hour postoperatively', 'description': 'measurement of time required for bromage scale to regress from 3 to 0'}, {'measure': 'duration of staying in PACU', 'timeFrame': '2 hours postoperatively', 'description': 'duration of parturient stay in PACU'}], 'secondaryOutcomes': [{'measure': 'Neonatal Apgar score at 1 minute', 'timeFrame': '1 minute post delivery', 'description': 'Neonatal Apgar score will be recorded at 1 minute after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts'}, {'measure': 'Neonatal Apgar score at 5 minutes', 'timeFrame': '1 minute post delivery', 'description': 'Neonatal Apgar score will be recorded at 5 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts'}, {'measure': 'neonatal blood gases', 'timeFrame': '1 minute post delivery', 'description': 'fetal cord blood analysis will be performed immediately post-delivery'}, {'measure': 'incidence of neonatal acidosis', 'timeFrame': '1 minute post delivery', 'description': 'incidence of neonatal acidosis (PH\\<7.2) will be recorded'}, {'measure': 'incidence of hypotension', 'timeFrame': 'intraoperative', 'description': 'any occurence of hypotension (systolic blood pressure\\<80% of baseline) throughout the operation will be recorded'}, {'measure': 'incidence of bradycardia', 'timeFrame': 'intraoperative', 'description': 'any incidence of maternal bradycardia (heart rate\\<60/min) will be recorded'}, {'measure': 'need for vasoconstrictor', 'timeFrame': 'intraoperative', 'description': 'any need for vasoconstrictor during the operation will be recorded'}, {'measure': 'need for atropine', 'timeFrame': 'intraoperative', 'description': 'any need for atropine during the operation because of bradycardia will be recorded'}, {'measure': 'incidence of nausea/vomiting', 'timeFrame': 'intraoperative', 'description': 'any occurence of nausea and/or vomiting during the operation will be recorded'}, {'measure': 'incidence of dizziness', 'timeFrame': 'intraoperative', 'description': 'any occurence of dizziness during the operation will be recorded'}, {'measure': 'incidence of drowsiness', 'timeFrame': 'intraoperative', 'description': 'any occurence of drowsiness during the operation will be recorded'}, {'measure': 'incidence of discomfort', 'timeFrame': 'intraoperative', 'description': 'any occurence of discomfort during the operation will be recorded'}, {'measure': 'incidence of shivering', 'timeFrame': 'intraoperative', 'description': 'any occurence of shivering during the operation will be recorded'}, {'measure': 'need for rescue analgesia in PACU', 'timeFrame': '2 hours postoperatively', 'description': 'need for rescue analgesia in PACU when VAS scale \\>4 will be recorded'}, {'measure': 'time from spinal anesthesia to rescue analgesia in PACU', 'timeFrame': '2 hours postoperatively', 'description': 'time from spinal anesthesia to rescue analgesia in PACU will be recorded'}, {'measure': 'incidence of neurological symptoms during hospital stay', 'timeFrame': '5 days postoperatively', 'description': 'incidence of neurological symptoms during hospitalization will be recorded'}, {'measure': 'incidence of neurological symptoms 2 months after the operation', 'timeFrame': '2 months after discharge', 'description': 'incidence of neurological symptoms 2 months after discharge from the hospital will be recorded by phone communication'}, {'measure': 'incidence of low back pain', 'timeFrame': '2 months after discharge', 'description': 'incidence of low back pain 2 months after discharge from the hospital will be recorded by phone communication'}, {'measure': 'time from spinal anesthesia to mobilization', 'timeFrame': '2 days postoperatively', 'description': 'time from spinal anesthesia to mobilization of parturient will be recorded'}, {'measure': "mother's satisfaction from anesthesia", 'timeFrame': '1 day postoperatively', 'description': "mother's satisfaction from anesthesia will be recorded using Likert scale. Likert scale ranges from 1 which is the minimum satisfaction to 4 which is the maximum satisfaction"}, {'measure': "gynecologist's satisfaction", 'timeFrame': '1 hour postoperatively', 'description': "gynecologist's satisfaction from anesthesia will be recorded using Likert scale. Likert scale ranges from 1 which is the minimum satisfaction to 4 which is the maximum satisfaction"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section', 'Local Anesthetic']}, 'referencesModule': {'references': [{'pmid': '26608876', 'type': 'BACKGROUND', 'citation': 'Maes S, Laubach M, Poelaert J. Randomised controlled trial of spinal anaesthesia with bupivacaine or 2-chloroprocaine during caesarean section. Acta Anaesthesiol Scand. 2016 May;60(5):642-9. doi: 10.1111/aas.12665. Epub 2015 Nov 26.'}, {'pmid': '30237085', 'type': 'BACKGROUND', 'citation': 'Saporito A, Ceppi M, Perren A, La Regina D, Cafarotti S, Borgeat A, Aguirre J, Van De Velde M, Teunkens A. Does spinal chloroprocaine pharmacokinetic profile actually translate into a clinical advantage in terms of clinical outcomes when compared to low-dose spinal bupivacaine? A systematic review and meta-analysis. J Clin Anesth. 2019 Feb;52:99-104. doi: 10.1016/j.jclinane.2018.09.003. Epub 2018 Sep 18.'}, {'pmid': '33776083', 'type': 'BACKGROUND', 'citation': 'Singariya G, Choudhary K, Kamal M, Bihani P, Pahuja H, Saini P. Comparison of analgesic efficacy of intrathecal 1% 2-chloroprocaine with or without fentanyl in elective caesarean section: A prospective, double-blind, randomised study. Indian J Anaesth. 2021 Feb;65(2):102-107. doi: 10.4103/ija.IJA_816_20. Epub 2021 Feb 10.'}, {'pmid': '37227957', 'type': 'BACKGROUND', 'citation': 'Baribeault T, Suss S. Spinal Anesthesia with 2-Chloroprocaine and Dexmedetomidine for Cesarean Section: A Case Report. AANA J. 2023 Jun;91(3):194-196.'}]}, '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', 'detailedDescription': 'Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided. Combined spinal-epidural anesthesia has become the favorable technique for both elective and emergency cesarean sections. Various local anesthetics have been used, but ropivacaine is the drug of choice in most hospitals in Greece. However, chloroprocaine is a preferable local anesthetic in USA due to its quick and predictable onset of action. Chloroprocaine was initially used in 1980, but it became obsolete in those years due to neurological symptoms associated with its use caused mainly by the presence of sodium bisulfite and disodium ethylenediaminetetraacetate (EDTA) in the early formulations. Nowadays, new formulations of the drug without EDTA makes chloroprocaine safe for use.\n\nThe aim of the current randomized controlled trial will be to compare the effect of an intrathecal fixed dose of chloroprocaine versus an intrathecal fixed dose of ropivacaine in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult parturients, American Society of Anesthesiologists (ASA) I-II,\n* singleton gestation\\>37 weeks\n* elective cesarean section\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) \\> III\n* age \\< 18 years\n* singleton gestation \\<37 weeks\n* Body Mass Index (BMI) \\>40 kg/m2\n* Body weight \\<50 kg\n* Body weight\\>100 kg\n* height\\<150 cm\n* height\\>180 cm\n* multiple gestation\n* emergency delivery\n* fetal abnormality\n* fetal distress\n* pregnancy-induced pathology such as preeclampsia, eclampsia, premature labor, placental abnormalities\n* pregnancy- induced diseases such as hepatic failure, pseudocholinesterase deficiency, neuromuscular diseases\n* lack of informed consent\n* contraindication for regional anesthesia such as thrombocytopenia, coagulation abnormalities, allergy to local anesthetics'}, 'identificationModule': {'nctId': 'NCT06376058', 'acronym': 'annie-mariana', 'briefTitle': 'Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Aretaieion University Hospital'}, 'officialTitle': 'Intrathecal Use of Chloroprocaine 1% and Ropivacaine 0,75% During Elective Cesarean Section. A Comparative Study', 'orgStudyIdInfo': {'id': '434/06-06-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'chloroprocaine group', 'description': 'intrathecal fixed dose of chloroprocaine 1%', 'interventionNames': ['Drug: Chloroprocaine 1% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ropivacaine group', 'description': 'intrathecal fixed dose of ropivacaine 0.75%', 'interventionNames': ['Drug: Ropivacaine 0.75% Injectable Solution']}], 'interventions': [{'name': 'Chloroprocaine 1% Injectable Solution', 'type': 'DRUG', 'description': '• in parturients allocated to the chloroprocaine group, a fixed dose of chloroprocaine 1% will be administered intrathecally', 'armGroupLabels': ['chloroprocaine group']}, {'name': 'Ropivacaine 0.75% Injectable Solution', 'type': 'DRUG', 'description': '• in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally', 'armGroupLabels': ['ropivacaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'CONTACT', 'email': 'ktheodoraki@hotmail.com', 'phone': '6974634162'}, {'name': 'Marianna Mavromati, MD', 'role': 'CONTACT', 'email': 'marimavr14@gmail.com'}], 'facility': 'Aretaieion University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'CONTACT', 'email': 'ktheodoraki@hotmail.com', 'phone': '6974634162'}, {'name': 'Marianna Mavromati, MD', 'role': 'CONTACT', 'email': 'marimavr14@gmail.com'}], 'overallOfficials': [{'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aretaieion University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aretaieion University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Dr Kassiani Theodoraki', 'investigatorAffiliation': 'Aretaieion University Hospital'}}}}