Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-31 @ 9:22 PM
Study NCT ID:
NCT04285333
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2020-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059787', 'term': 'Acute Pain'}], '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': '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': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'all blocks were performed in a special area outside operating room by docters only implicated in performance assessement of block and not in patient care. Patients where after moved to operating room, care provider wil assess pain before spinal anesthesia'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomised single blinded study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-11', 'studyFirstSubmitDate': '2020-02-09', 'studyFirstSubmitQcDate': '2020-02-23', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positioning pain', 'timeFrame': 'up to 30 minutes', 'description': 'Verbal Rating Scale (VRS) \\[0=no pain ; 4=worst pain\\]'}], 'secondaryOutcomes': [{'measure': 'Positioning Rating', 'timeFrame': 'up to 40 minutes', 'description': 'verbal rating scale (VRS) \\[0=no pain ; 4=worst pain\\]'}, {'measure': 'Imaging time', 'timeFrame': 'up to 10 minutes', 'description': 'For the PENG block:the femoral artery, the anterior inferior iliac spine, the iliopubic eminence and the psoas tendon.\n\nFor the FIB: the femoral artery, the iliacus muscle, the fascia iliaca and the fascia lata.'}, {'measure': 'Puncture time', 'timeFrame': 'up to 10 minutes', 'description': 'the time that stretches from the introduction of the needle until the end of the injection of local anesthetic'}, {'measure': 'Performance time', 'timeFrame': 'up to 10 minutes', 'description': 'the imaging time + time to puncture.'}, {'measure': 'Number of punctures', 'timeFrame': 'up to 10 minutes', 'description': 'the number of redirection of the needle after removing 2 cm.'}, {'measure': 'pain 5 after block', 'timeFrame': 'up to 5 minutes', 'description': 'verbal rating scale (VRS) \\[0=no pain ; 4=worst pain\\]'}, {'measure': 'pain 10 after block', 'timeFrame': 'up to 10 minutes', 'description': 'verbal rating scale (VRS) \\[0=no pain ; 4=worst pain\\]'}, {'measure': 'pain 15 after block', 'timeFrame': 'up to 15 minutes', 'description': 'verbal rating scale (VRS) \\[0=no pain ; 4=worst pain\\]'}, {'measure': 'pain 20 after block', 'timeFrame': 'up to 20 minutes', 'description': 'verbal rating scale (VRS) \\[0=no pain ; 4=worst pain\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip fracture', 'nerve block', 'spinal anesthesia', 'analgesia'], 'conditions': ['Hip Fracture', 'Analgesia', 'Acute Pain']}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia (SA) is a widely accepted anesthetic technique for hip fracture repair among elderly. Positioning for SA can be extremely painful. Effective management of pain is important for these patients comfort.\n\nFascia Iliaca block (FIB) and Femoral nerve blocks are commonly used for analgesia in hip fracture patients. However, they often provide a modest reduction in pain.\n\nThe Percapsular Nerve Group block (PENG Block) has the advantage that it covers the accessory obturator nerve.\n\nAim of the study: compare FIB with PENG prior to positioning hip fracture patients for standardized SA.\n\nIn a prospective randomized double blind we included 80 patients aged more than 65 years old, for whom pain was felt when raising the affected limb to 15 degrees. Patients were assigned to receive either ultrasound guided Fascia Iliaca block or Percapsular Nerve Group block using 20 mL Lidocaine 1.5% in both groups. We compared pain on positioning for spinal anesthesia using Verbal Rating Scale (VRS 0 = no pain , VRS 1 = mild pain, t 2= severe pain) for both groups. We also recorded different times to perfom block.', 'detailedDescription': 'The purpose of the study was to compare analgesis effect of Percapsula nerve group block to fascia iliaca block prior to positioning hip fracture patients for standardized SA. We included 80 patients reporting pain with Verbal Rating Scale at 2 when raising the affected limb to 15 degrees. All patients admitted to induction room, were given standard monitoring and we randomized to receive either: ultrasound fascia iliaca block using linear high frequency ultrasound probe (10-15MHz) placed in a transverse direction over the anterior thigh below the inguinal ligament. A 50 mm needle was advanced until the tips placed underneath the fascia iliaca and 20 mL 1.5% Lidocaine was injected or ultrasound Percapsula nerve group block A curvilinear using low-frequency ultrasound probe (2-5MHz) that was initially placed in a transverse plane over the anterior inferior iliac spine and then aligned with the pubic ramus by rotating the probe counter clockwise approximately 45 degrees. In this view, the iliopubic eminence , the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed and than a 100 mm needle was advanced to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly and 20 mL 1.5% Lidocaine.We compared pain on positioning for spinal anesthesia and also different time to realise both blocks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\- Patients aged ≥ 65 years old and undergoing hip fracture surgical repair under continuous spinal anesthesia (CSA).\n* Patients for whom pain was felt when raising the affected limb to 15 degrees (VERBAL PAIN SCALE =2)\n\nExclusion Criteria:\n\n* \\- ASA physical status ≥ 4.\n* Impaired cognition or Dementia.\n* Multiple fractures.\n* Contraindication to regional anesthesia.\n* Patient's disapproval."}, 'identificationModule': {'nctId': 'NCT04285333', 'briefTitle': 'Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Analgesic Techniques Before Spinal Anesthesia for Hip Fracture Repair: Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block', 'orgStudyIdInfo': {'id': 'CE-IMKO 102/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fascial iliaca', 'description': ': A linear high frequency ultrasound probe (10-15MHz) was placed in a transverse direction over the anterior thigh below the inguinal ligament. We identified the femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca. The needle was inserted in plane and a 22 gauge, 50 mm needle was advanced until the tips placed underneath the fascia iliaca. Following negative aspiration, the local anesthetic solution was injected in 5mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine', 'interventionNames': ['Procedure: fascia iliaca block']}, {'type': 'EXPERIMENTAL', 'label': 'Percapsular nerve group block', 'description': 'A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine.', 'interventionNames': ['Procedure: percapsular nerve group block']}], 'interventions': [{'name': 'fascia iliaca block', 'type': 'PROCEDURE', 'otherNames': ['BIF for hip fracture'], 'description': 'ultrasound guided block with 20 mL lidocaine 1.5%', 'armGroupLabels': ['fascial iliaca']}, {'name': 'percapsular nerve group block', 'type': 'PROCEDURE', 'otherNames': ['PENG block for hip fracture'], 'description': 'ultrasound guided block with 20 mL lidocaine 1.5%', 'armGroupLabels': ['Percapsular nerve group block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Tunis', 'country': 'Tunisia', 'facility': "Institut Kassab D'Orthopedie", 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'khaireddine Raddaoui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tunis El Manar University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'collaborators': [{'name': "Institut Kassab d'Orthopédie", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Olfa kaabachi, MD', 'investigatorAffiliation': 'University Tunis El Manar'}}}}