Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-31 @ 9:56 AM
Study NCT ID:
NCT05444803
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2022-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia', 'timeFrame': '30 minutes', 'description': 'Pain scores will be assessed by Numerical Rating Scale (NRS) scores (from 0=no pain to 10=maximum possible pain).'}], 'secondaryOutcomes': [{'measure': 'Rate of pain scores at rest', 'timeFrame': '30 min', 'description': 'Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain) at rest before and 30 min after the block performance.'}, {'measure': 'Rate of pain scores on passive limb lifting', 'timeFrame': '30 min', 'description': 'Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain) on passive limb lifting before and 30 min after the block performance.'}, {'measure': 'rate of postoperative pain scores', 'timeFrame': '24 hours', 'description': 'Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain).at 6, 12, 24 hours postoperatively.'}, {'measure': 'Amount of postoperative analgesic consumption', 'timeFrame': '24 hours', 'description': 'Postoperative analgesic consumption will be recorded for postoperative 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Anesthesia', 'Analgesia', 'Hip Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia', 'detailedDescription': 'Spinal anesthesia is commonly used in patients undergoing hip fracture surgery. However the procedure of patient positioning to perform a spinal block is painful and may require the administration of IV analgesics or some regional anesthesia techniques such as femoral nerve block, fascia-iliaca compartment block, peri-capsular nerve group block. At the study, the investigators aimed to compare analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with hip fracture scheduled for surgery under spinal anesthesia.\n\nExclusion Criteria:\n\n* hemorrhagic diathesis,\n* peripheral neuropathy,\n* allergy to local anesthetics,\n* mental disorders,\n* use of analgesics for 8 h before the performance of spinal block'}, 'identificationModule': {'nctId': 'NCT05444803', 'briefTitle': 'Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'Comparison of Femoral Nerve Block Versus Peri-capsular Nerve Group Block for Analgesia During Positioning for Spinal Anesthesia in Patients With Hip Fracture', 'orgStudyIdInfo': {'id': 'safa1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Femoral nerve block group', 'description': 'Thirty minutes before the placement of spinal block, patients will be receive a femoral nerve block with Bupivacaine.', 'interventionNames': ['Other: femoral nerve block']}, {'type': 'OTHER', 'label': 'Peri-capsular nerve group block group', 'description': 'Thirty minutes before the placement of spinal block, patients will be receive a peri-capsular nerve group block with Bupivacaine.', 'interventionNames': ['Other: peri-capsular nerve group block']}], 'interventions': [{'name': 'femoral nerve block', 'type': 'OTHER', 'description': 'Patients will be performed a femoral nerve block using bupivacaine thirty minutes before the performing of spinal block.', 'armGroupLabels': ['Femoral nerve block group']}, {'name': 'peri-capsular nerve group block', 'type': 'OTHER', 'description': 'Patients will be performed a peri-capsular nerve group block using bupivacaine thirty minutes before the performing of spinal block.', 'armGroupLabels': ['Peri-capsular nerve group block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Antalya Training and Research Hospital', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Safa Eroglu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Traning and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}