Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:24 AM
Study NCT ID:
NCT06336460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PENG vs. FIC Blocks in Hip Fractures in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The research associate/outcome assessor will not have access to group assignment and will therefore be blinded to the type of block. Although the patient, their caregiver(s), and the clinician caring for the patient will not be directly informed of the group assignment, a note will be logged in the clinical record by the physician placing the block indicating the details of the block after this procedure has been completed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric pain score at 30 minutes', 'timeFrame': '30 minutes after block placement'}, {'measure': 'Numeric pain score at 60 minutes', 'timeFrame': '1 hour after block placement'}], 'secondaryOutcomes': [{'measure': 'Cumulative Morphine Milligram Equivalents in 24 hours after enrollment', 'timeFrame': '24 hours after enrollment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures', 'Nerve Block', 'Analgesia']}, 'referencesModule': {'references': [{'pmid': '20165729', 'type': 'BACKGROUND', 'citation': 'Bhoi S, Chandra A, Galwankar S. Ultrasound-guided nerve blocks in the emergency department. J Emerg Trauma Shock. 2010 Jan;3(1):82-8. doi: 10.4103/0974-2700.58655.'}, {'pmid': '31262265', 'type': 'BACKGROUND', 'citation': 'Pasquier M, Taffe P, Hugli O, Borens O, Kirkham KR, Albrecht E. Fascia iliaca block in the emergency department for hip fracture: a randomized, controlled, double-blind trial. BMC Geriatr. 2019 Jul 1;19(1):180. doi: 10.1186/s12877-019-1193-0.'}, {'pmid': '30063657', 'type': 'BACKGROUND', 'citation': 'Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.'}, {'pmid': '32532621', 'type': 'BACKGROUND', 'citation': 'Luftig J, Dreyfuss A, Mantuani D, Howell K, White A, Nagdev A. A new frontier in pelvic fracture pain control in the ED: Successful use of the pericapsular nerve group (PENG) block. Am J Emerg Med. 2020 Dec;38(12):2761.e5-2761.e9. doi: 10.1016/j.ajem.2020.05.085. Epub 2020 May 28.'}, {'pmid': '37678449', 'type': 'BACKGROUND', 'citation': 'Marrone F, Graziano G, Paventi S, Tomei M, Gucciardino P, Bosco M. Analgesic efficacy of Pericapsular Nerve Group (PENG) block compared with Fascia Iliaca Block (FIB) in the elderly patient with fracture of the proximal femur in the emergency room. A randomised controlled trial. Rev Esp Anestesiol Reanim (Engl Ed). 2023 Nov;70(9):501-508. doi: 10.1016/j.redare.2022.10.010. Epub 2023 Sep 6.'}, {'pmid': '34290085', 'type': 'BACKGROUND', 'citation': 'Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>= 18 years of age)\n* Isolated proximal hip fracture (defined as Intertrochanteric or more proximal) as identified by X-ray, Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) scan\n* Glasgow Coma Score (GCS) = 15\n* Subjective pain score of \\>= 5 on a scale of 0 to 10 just prior to the nerve block placement\n\nExclusion Criteria:\n\n* Patients who are unable to give consent due to altered mental status or dementia\n* Clinically intoxicated patients\n* Patients who are unable to communicate their numeric level of pain\n* Open fracture or penetrating hip trauma\n* Signs of infection or laceration at injection site\n* Patients with multi-system trauma\n* Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of hip fracture pain, e.g. humerus fracture, dislocated joint)\n* Requiring immediate surgical intervention (\\< 1 hour)\n* Deemed clinically unstable by treating physician\n* Abnormal vital signs (Pulse\\>120bpm, Systolic blood pressure \\< 100 mm Hg, Pulse O2 \\< 95%)\n* Patients on long-acting systemic opioid analgesia\n* Allergy to amide local anesthetics\n* Vulnerable populations including pregnant patients, prisoners, children, elderly dementia patients. All precautions will be taken to avoid coercion, harm and exploitation of these vulnerable populations, thus they are to be excluded from this study. They will receive pain medications as deemed appropriate by their treating physician.'}, 'identificationModule': {'nctId': 'NCT06336460', 'briefTitle': 'PENG vs. FIC Blocks in Hip Fractures in the ED', 'organization': {'class': 'OTHER', 'fullName': 'Orange Park Medical Center'}, 'officialTitle': 'Pericapsular Nerve Group (PENG) Block vs. the Fascia Iliaca Compartment (FIC) Block for Patients With Isolated Hip Fractures in the Emergency Department', 'orgStudyIdInfo': {'id': '2023-537'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pericapsular Nerve Group (PENG) Block', 'interventionNames': ['Procedure: Pericapsular Nerve Group (PENG) Block']}, {'type': 'EXPERIMENTAL', 'label': 'Fascia Iliaca Compartment (FIC) Block', 'interventionNames': ['Procedure: Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures']}], 'interventions': [{'name': 'Pericapsular Nerve Group (PENG) Block', 'type': 'PROCEDURE', 'description': 'Under sterile technique, physician will identify relevant landmarks including the femoral artery, femoral vein, femoral nerve, ileopubic eminence (IPE), anterior inferior iliac spine (AIIS), psoas tendon (PT). Target area is bony space between AIIS and IPE adjacent to PT.\n\nUsing in-plane technique with constant visualization, needle will be inserted through skin and soft tissue targeting fascial plane below the psoas tendon, above ilium bone. Landmark lies between the AIIS and IPE, just lateral to psoas tendon.\n\nAs needle tip reaches target, small volume of normal saline will be injected to hydrodissect tissue. Fluid will start to spread along fascial plane, lifting the psoas tendon from ilium, confirming proper positioning.\n\nNormal saline will then be switched to anesthetic (30mL of Bupivacaine 0.25%).\n\nAfter full volume of anesthetic has been injected, a small volume (5mL) of normal saline will be injected to flush line of remaining anesthetic. Needle will then be withdrawn.', 'armGroupLabels': ['Pericapsular Nerve Group (PENG) Block']}, {'name': 'Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures', 'type': 'PROCEDURE', 'description': 'Under sterile technique, physician will identify relevant landmarks, including femoral artery, femoral vein, femoral nerve, iliacus muscle with overlying fascia iliaca.\n\nUsing in-plane technique with constant visualization, needle will be inserted through skin and soft tissue targeting the fascial plane above iliacus muscle.\n\nAs needle tip reaches the target, a small volume of normal saline will be injected to hydrodissect tissue. Fluid will start to spread along fascial plane, confirming proper positioning.\n\nNormal saline will then be switched to anesthetic (30mL of Bupivacaine 0.25%).\n\nAfter full volume of anesthetic has been injected, a small volume (5mL) of normal saline will be injected to flush the line of remaining anesthetic. The needle will then be withdrawn.', 'armGroupLabels': ['Fascia Iliaca Compartment (FIC) Block']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Taryn Hoffman, MD', 'role': 'CONTACT', 'email': 'taryn_hoffman@teamhealth.com', 'phone': '(904) 639 - 8500'}], 'overallOfficials': [{'name': 'Taryn Hoffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HCA Florida Orange Park Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orange Park Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}