Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT05136534
Status:
COMPLETED
Last Update Posted:
2021-11-29
First Post:
2021-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spinal Versus Local Anesthesia for Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-10-21', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessed by NRS', 'timeFrame': '13 months', 'description': 'Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subarachnoid', 'anesthesia', 'prilocaine'], 'conditions': ['Hernia, Inguinal']}, 'referencesModule': {'references': [{'pmid': '37386519', 'type': 'DERIVED', 'citation': 'Costa F, Pascarella G, Luffarelli P, Strumia A, Biondo G, Piliego C, Alloni R, Agro FE. Selective spinal anesthesia with hyperbaric prilocaine provides better perioperative pain control than local anesthesia for ambulatory inguinal hernia repair without affecting discharging time: a randomized controlled trial. J Anesth Analg Crit Care. 2022 Jan 31;2(1):6. doi: 10.1186/s44158-022-00034-x.'}]}, 'descriptionModule': {'briefSummary': 'patients underwent inguinal hernia repair; Group A patients received Subarachnoid anesthesia; Group B Patients underwent surgery with local anesthesia (Mepivacaine 2%) performed by the surgeon; Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,', 'detailedDescription': "All patients underwent inguinal hernia repair with the Trabucco's technique (15), performed by the same surgical team. Every patient was adequately informed of the procedural sequence of anesthesia and surgery and signed informed consent before being enrolled in the study.\n\nFor both groups, patients received mild sedation with Midazolam 0.03 mg/kg i.v.; Paracetamol 1 gr and Ketorolac 30 mg i.v. were given before surgery as multimodal pre-emptive analgesia.\n\nGroup A Subarachnoid anesthesia was performed with a 27G Whitacre needle at L2-L3 interspace, with patients on the lateral decubitus corresponding to the side of surgery. The introducer was inserted in the middle point of the space between two spinous processes, with a slightly cranial direction. The spinal needle was passed through the introducer and advanced till the subarachnoid space was reached, as confirmed by cerebrospinal fluid outflow.\n\nSubsequently, 60 mg of Prilocaine 2% were administered in the subarachnoid space, with a low-flow injection technique and the needle bevel turned laterally towards the sloping surgical side. Lateral decubitus was maintained for at least 10 minutes (16).\n\nAt 15 minutes from spinal anesthesia execution, and before surgery started, sensory and motor block were assessed by ice-test and numerical 0-3 Bromage Scale, respectively.\n\nGroup B Patients underwent surgery with local anesthesia (Mepivacaine 2%) performed by the surgeon before skin incision. Further infiltrations of local anesthetic were ensured in case of pain during the surgery, for a maximum of 400 mg of mepivacaine.\n\nIn case of uncontrolled pain, fentanyl 50 mcg i.v. was given for a maximum of two intraoperative administrations. If pain persisted, a deep sedation was performed with propofol continuous i.v. infusion.\n\nPain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: indication for inguinal hernia repair; signed informed consent\n\n\\-\n\nExclusion Criteria: neurological disorders; allergy to local anesthetics; liver disease; serious cardiac conduction problems; severe anemia; cardiogenic or hypovolemic shock; congenital or acquired methemoglobinemia; primitive changes in coagulation; patients treated with class III antiarrhythmics (amiodarone); patients who did not suspend anticoagulants/antiplatelet agents; pregnant patients.'}, 'identificationModule': {'nctId': 'NCT05136534', 'acronym': 'SPINOFAST', 'briefTitle': 'Spinal Versus Local Anesthesia for Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Selective Spinal Anesthesia With Hyperbaric Prilocaine Provides Better Perioperative Pain Control Than Local Anesthesia for Ambulatory Inguinal Hernia Repair Without Affecting Discharging Time: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '14.16 TS ComEt CBM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'subarachnoid anesthesia wit hyperbaric prilocaine', 'interventionNames': ['Procedure: spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'local anesthesia + mild sedation', 'interventionNames': ['Procedure: local anesthesia']}], 'interventions': [{'name': 'spinal anesthesia', 'type': 'PROCEDURE', 'description': 'subarachnoid anesthesia with 2% hyperbaric pilicaine', 'armGroupLabels': ['group A']}, {'name': 'local anesthesia', 'type': 'PROCEDURE', 'description': '(Mepivacaine 2%) performed by the surgeon before skin incision', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'country': 'Italy', 'facility': 'CampusBioMedico', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Fabio Costa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campus Bio-Medico University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}