Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2026-01-06 @ 5:12 AM
Study NCT ID:
NCT02428257
Status:
UNKNOWN
Last Update Posted:
2015-04-28
First Post:
2015-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004809', 'term': 'Ephedrine'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients who experienced at least one episode of hypotension during surgery (fall of more than 20% of systolic blood pressure) among the 2 groups', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Total bupivacaine consumption', 'timeFrame': '2 hours', 'description': 'total dose of bupivacaine needed to perform the surgery (approximate duration of surgery : 2 hours)'}, {'measure': 'The percentage of patients who experienced at least one episode of bradycardia (heart rate<50 bpm) among the 2 groups', 'timeFrame': '2 hours'}, {'measure': 'vasopressor use', 'timeFrame': '2 hours', 'description': 'total ephedrine injected if hypotension occurred (approximate duration of surgery : 2 hours).'}, {'measure': 'fluid infusion', 'timeFrame': '2 hours', 'description': 'total fluid infused intravenously at the end of surgery (approximate duration of surgery : 2 hours).'}]}, 'conditionsModule': {'keywords': ['hip fracture', 'elderly', 'continous spinal anesthesia', 'hypobaric bupivacaine', 'isobaric bupivacaine', 'hypotension'], 'conditions': ['Hip Fracture', 'Hypotension']}, 'referencesModule': {'references': [{'pmid': '25058085', 'type': 'BACKGROUND', 'citation': 'Neuman MD, Rosenbaum PR, Ludwig JM, Zubizarreta JR, Silber JH. Anesthesia technique, mortality, and length of stay after hip fracture surgery. JAMA. 2014 Jun 25;311(24):2508-17. doi: 10.1001/jama.2014.6499.'}, {'pmid': '24972901', 'type': 'BACKGROUND', 'citation': 'Patorno E, Neuman MD, Schneeweiss S, Mogun H, Bateman BT. Comparative safety of anesthetic type for hip fracture surgery in adults: retrospective cohort study. BMJ. 2014 Jun 27;348:g4022. doi: 10.1136/bmj.g4022.'}, {'pmid': '16632842', 'type': 'RESULT', 'citation': 'Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the potential beneficial effects on hemodynamics when hypobaric bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture in elderly patients. Half of the patients will receive hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic data will be compared.', 'detailedDescription': 'Anesthesia for surgical repair of hip fracture is still controversial. Large retrospective studies and systematic reviews failed to demonstrate the superiority of either general or regional anesthesia. However, continuous spinal anesthesia has been shown to preserve hemodynamics better than general and single shoot spinal anesthesia. However, hypotension still occurs with continuous spinal anesthesia.\n\nUnilateral spinal anesthesia may be achieved by hypobaric bupivacaine when patients are in the lateral position. Unilateral spinal anesthesia is more effective in preserving hemodynamics by limiting the spread of the sympathetic blockade to the operated side.\n\nOur goal is to show that the use of hypobaric rather than isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture reduces incidence of hypotension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged more than 65 years and scheduled for a surgical repair of a hip fracture.\n\nExclusion Criteria:\n\n* contraindication to spinal anesthesia or peripheral nerve blocks including hemostasis anomalies, local infection, allergic reaction to local anesthetics.\n* dementia.\n* consent refusal.'}, 'identificationModule': {'nctId': 'NCT02428257', 'briefTitle': 'Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly', 'organization': {'class': 'OTHER', 'fullName': "Institut Kassab d'Orthopédie"}, 'officialTitle': 'Hypobaric Rather Than Isobaric Bupivacaine to Prevent Anesthesia-induced Hypotension in Patients Undergoing Surgical Repair of Hip Fracture Under Continuous Spinal Anesthesia: a Prospective Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'P-2015008AR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypobaric', 'description': 'continuous spinal anesthesia with 2,5 mg boluses of hypobaric bupivacaine, prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.', 'interventionNames': ['Procedure: continuous spinal anesthesia', 'Drug: hypobaric bupivacaine', 'Drug: ephedrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'isobaric', 'description': 'continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine', 'interventionNames': ['Procedure: continuous spinal anesthesia', 'Drug: isobaric bupivacaine', 'Drug: ephedrine']}], 'interventions': [{'name': 'continuous spinal anesthesia', 'type': 'PROCEDURE', 'description': 'Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side.', 'armGroupLabels': ['hypobaric', 'isobaric']}, {'name': 'hypobaric bupivacaine', 'type': 'DRUG', 'description': 'hypobaric bupivacaine was prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.', 'armGroupLabels': ['hypobaric']}, {'name': 'isobaric bupivacaine', 'type': 'DRUG', 'description': '0.5% isobaric bupivacaine', 'armGroupLabels': ['isobaric']}, {'name': 'ephedrine', 'type': 'DRUG', 'armGroupLabels': ['hypobaric', 'isobaric']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manouba', 'state': 'La Manouba', 'country': 'Tunisia', 'contacts': [{'name': 'Olfa Kaabachi, Professor', 'role': 'CONTACT', 'email': 'olfa.kaabachi@gnet.tn', 'phone': '+21698317381'}], 'facility': "Institut Kassab d'Orthopédie", 'geoPoint': {'lat': 36.81006, 'lon': 10.09557}}], 'centralContacts': [{'name': 'Karim Raies, A. Professor', 'role': 'CONTACT', 'email': 'karim.raies@gmail.com', 'phone': '+21655208602'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Kassab d'Orthopédie", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}