Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-26 @ 12:07 PM
Study NCT ID:
NCT05505604
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2022-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PENG vs FICB for Hip Fracture in ED Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive either a PENG or FICB. Baseline characteristics will be collected and NRS pain scores collected preblock and at specified time points post block.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2022-08-15', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '6 hours', 'description': 'Median pain score on 0-10 Numeric Rating Scale'}], 'secondaryOutcomes': [{'measure': 'Opioid use', 'timeFrame': 'From block administration until time of surgery or 24 hours if surgery performed >24 hours', 'description': 'Mean opioid consumption in morphine equivalents'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PENG', 'FICB', 'Fascia Iliaca Compartment Block', 'Pericapsular Nerve Group Block', 'Hip fracture'], 'conditions': ['Femoral Neck Fractures', 'Intertrochanteric Fractures']}, 'referencesModule': {'references': [{'pmid': '21413206', 'type': 'BACKGROUND', 'citation': 'Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Available from http://www.ncbi.nlm.nih.gov/books/NBK52651/'}, {'pmid': '34826609', 'type': 'BACKGROUND', 'citation': 'Kim CH, Yang JY, Min CH, Shon HC, Kim JW, Lim EJ. The effect of regional nerve block on perioperative delirium in hip fracture surgery for the elderly: A systematic review and meta-analysis of randomized controlled trials. Orthop Traumatol Surg Res. 2022 Feb;108(1):103151. doi: 10.1016/j.otsr.2021.103151. Epub 2021 Nov 23.'}, {'pmid': '33238043', 'type': 'BACKGROUND', 'citation': 'Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.'}, {'pmid': '23758305', 'type': 'BACKGROUND', 'citation': 'Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.'}, {'pmid': '12548273', 'type': 'BACKGROUND', 'citation': 'Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33. doi: 10.1067/mem.2003.51.'}, {'pmid': '29500558', 'type': 'BACKGROUND', 'citation': 'Ketelaars R, Stollman JT, van Eeten E, Eikendal T, Bruhn J, van Geffen GJ. Emergency physician-performed ultrasound-guided nerve blocks in proximal femoral fractures provide safe and effective pain relief: a prospective observational study in The Netherlands. Int J Emerg Med. 2018 Mar 2;11(1):12. doi: 10.1186/s12245-018-0173-z.'}, {'pmid': '21373300', 'type': 'BACKGROUND', 'citation': 'Godoy Monzon D, Vazquez J, Jauregui JR, Iserson KV. Pain treatment in post-traumatic hip fracture in the elderly: regional block vs. systemic non-steroidal analgesics. Int J Emerg Med. 2010 Nov 6;3(4):321-5. doi: 10.1007/s12245-010-0234-4.'}, {'pmid': '25430915', 'type': 'BACKGROUND', 'citation': "Reavley P, Montgomery AA, Smith JE, Binks S, Edwards J, Elder G, Benger J. Randomised trial of the fascia iliaca block versus the '3-in-1' block for femoral neck fractures in the emergency department. Emerg Med J. 2015 Sep;32(9):685-9. doi: 10.1136/emermed-2013-203407. Epub 2014 Nov 27."}, {'pmid': '31305398', 'type': 'BACKGROUND', 'citation': 'Hong HK, Ma Y. The efficacy of fascia iliaca compartment block for pain control after hip fracture: A meta-analysis. Medicine (Baltimore). 2019 Jul;98(28):e16157. doi: 10.1097/MD.0000000000016157.'}, {'type': 'BACKGROUND', 'citation': "Hadzic A. Blocks for Hip Analgesia. In: Lopez AM, Balocco AL, Vandepitte C, Hadzic A, eds. Hadzic's Peripheral Nerve Blocks and Anatomy for Ultrasound-Guided Regional Anesthesia. 3rd ed. New York: McGraw Hill; 2022."}, {'pmid': '9479711', 'type': 'BACKGROUND', 'citation': 'Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.'}, {'pmid': '29140962', 'type': 'BACKGROUND', 'citation': 'Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.'}, {'pmid': '34715388', 'type': 'BACKGROUND', 'citation': 'Mosaffa F, Taheri M, Manafi Rasi A, Samadpour H, Memary E, Mirkheshti A. Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled clinical trial. Orthop Traumatol Surg Res. 2022 Feb;108(1):103135. doi: 10.1016/j.otsr.2021.103135. Epub 2021 Oct 29.'}, {'pmid': '35701386', 'type': 'BACKGROUND', 'citation': 'Fahey A, Cripps E, Ng A, Sweeny A, Snelling PJ. Pericapsular nerve group block for hip fracture is feasible, safe and effective in the emergency department: A prospective observational comparative cohort study. Emerg Med Australas. 2022 Dec;34(6):884-891. doi: 10.1111/1742-6723.14013. Epub 2022 Jun 14.'}, {'pmid': '34086782', 'type': 'BACKGROUND', 'citation': 'Allard C, Pardo E, de la Jonquiere C, Wyniecki A, Soulier A, Faddoul A, Tsai ES, Bonnet F, Verdonk F. Comparison between femoral block and PENG block in femoral neck fractures: A cohort study. PLoS One. 2021 Jun 4;16(6):e0252716. doi: 10.1371/journal.pone.0252716. eCollection 2021.'}, {'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.'}, {'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': '34584279', 'type': 'BACKGROUND', 'citation': 'Jadon A, Mohsin K, Sahoo RK, Chakraborty S, Sinha N, Bakshi A. Comparison of supra-inguinal fascia iliaca versus pericapsular nerve block for ease of positioning during spinal anaesthesia: A randomised double-blinded trial. Indian J Anaesth. 2021 Aug;65(8):572-578. doi: 10.4103/ija.ija_417_21. Epub 2021 Aug 25.'}, {'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': '34027410', 'type': 'BACKGROUND', 'citation': 'Rocha-Romero A, Arias-Mejia K, Salas-Ruiz A, Peng PWH. Pericapsular nerve group (PENG) block for hip fracture in the emergency department: a case series. Anaesth Rep. 2021 May 18;9(1):97-100. doi: 10.1002/anr3.12118. eCollection 2021 Jan-Jun.'}, {'pmid': '35652877', 'type': 'BACKGROUND', 'citation': 'Gullupinar B, Saglam C, Unluer EE, Ayvat P, Ozturk K, Gul M, Tandon S. Effectiveness of pericapsular nerve group block with ultrasonography in patients diagnosed with hip fracture in the emergency department. Ulus Travma Acil Cerrahi Derg. 2022 Jun;28(6):832-838. doi: 10.14744/tjtes.2022.67817.'}, {'pmid': '33637625', 'type': 'BACKGROUND', 'citation': 'Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.'}, {'pmid': '31272654', 'type': 'BACKGROUND', 'citation': 'Desmet M, Balocco AL, Van Belleghem V. Fascia iliaca compartment blocks: Different techniques and review of the literature. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):57-66. doi: 10.1016/j.bpa.2019.03.004. Epub 2019 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'Regional anesthesia for hip fractures has been shown to decrease rates of delirium in elderly patients with hip fractures as well as improve pain compared to systemic opioids. The Pericapsular Nerve Group (PENG) block has recently received attention as an alternative approach to femoral nerve block and Fascia Iliaca Compartment Block (FICB). The investigators seek to evaluate if there is a difference between the PENG and FICB in terms of efficacy of pain control in ED patients presenting with hip fracture. We hypothesize that the PENG block may be superior based on previous research.', 'detailedDescription': 'Fractures of the proximal femur are a common presentation to the emergency department and are an acutely painful condition. This condition predominantly affects elderly patients who are at risk for delirium and more susceptible to the adverse effects of systemic opioids. Regional anesthesia is an recommended component of pain control for elderly patients with hip fracture. The investigators seek to compare the efficacy of pain control of the Pericapsular Nerve Group (PENG) block with the Fascia Iliaca Compartment Block (FICB).\n\nPrevious studies have suggested that the PENG block may be superior to the FICB for pain control and results in less thigh motor weakness. The investigators will compare pain control (by difference in mean VAS score at set time points), systemic opioid use (in mean morphine equivalents prior to surgery), and motor function in patients with hip fractures who receive either block in the ED.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proximal femur fracture\n\nExclusion Criteria:\n\n* refusal to consent\n* hemodynamic instability\n* allergy to local anesthetics\n* severe injury with instability\n* severe medical conditions with instability'}, 'identificationModule': {'nctId': 'NCT05505604', 'briefTitle': 'PENG vs FICB for Hip Fracture in ED Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Comparison of Pericapsular Nerve Group Block (PENG) Versus Fascia Iliaca Compartment Block (FICB) for Hip Fracture Analgesia in Emergency Department Patients', 'orgStudyIdInfo': {'id': 'HSR220275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PENG', 'description': 'Patients with hip fracture randomized to receive PENG block', 'interventionNames': ['Procedure: PENG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FICB', 'description': 'Patients with hip fracture randomized to received FICB', 'interventionNames': ['Procedure: FICB']}], 'interventions': [{'name': 'PENG', 'type': 'PROCEDURE', 'description': 'patients will receive an ultrasound-guided Pericapsular Nerve Group Block with 20mL of 0.25% bupivacaine (not to exceed 2mg/kg)', 'armGroupLabels': ['PENG']}, {'name': 'FICB', 'type': 'PROCEDURE', 'description': 'Patients will receive an ultrasound-guided Fascia Iliaca Compartment Block with 20 mL of 0.25% bupivacaine (not to exceed 2 mg/kg) diluted to total volume of 40 mL of injectate', 'armGroupLabels': ['FICB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Kongkatong, MD', 'role': 'CONTACT', 'email': 'mk3wk@hscmail.mcc.virginia.edu', 'phone': '434-924-8485'}, {'name': 'Christopher Thom, MD', 'role': 'CONTACT', 'email': 'ct9k@hscmail.mcc.virginia.edu', 'phone': '4349248485'}, {'name': 'Matthew Kongkatong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christopher Thom, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Han, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jakob Ottenhoff, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'John Hedrick, PharmD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Emergency Medicine', 'investigatorFullName': 'Matthew Kongkatong, MD', 'investigatorAffiliation': 'University of Virginia'}}}}