Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT04426058
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2020-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CMP vs Fascia Iliaca Block
Sponsor:
Organization:
Raw JSON
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Total hip arthroplasty and peripheral nerve blocks: Limited but salient role? J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):379-380. doi: 10.4103/joacp.JOACP_114_18. No abstract available.'}, {'pmid': '30386022', 'type': 'BACKGROUND', 'citation': 'Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.'}, {'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': '31371038', 'type': 'BACKGROUND', 'citation': 'Hannon CP, Keating TC, Lange JK, Ricciardi BF, Waddell BS, Della Valle CJ. Anesthesia and Analgesia Practices in Total Joint Arthroplasty: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2019 Dec;34(12):2872-2877.e2. doi: 10.1016/j.arth.2019.06.055. Epub 2019 Jul 8.'}, {'pmid': '26767235', 'type': 'BACKGROUND', 'citation': 'Kumar K, Pandey RK, Bhalla AP, Kashyap L, Garg R, Darlong V, Malhotra R, Yadav CS. Comparison of conventional infrainguinal versus modified proximal suprainguinal approach of Fascia Iliaca Compartment Block for postoperative analgesia in Total Hip Arthroplasty. A prospective randomized study. Acta Anaesthesiol Belg. 2015;66(3):95-100.'}], 'seeAlsoLinks': [{'url': 'https://rapm.bmj.com/content/early/2019/05/16/rapm-2018-100174?versioned=true', 'label': 'Randomized trial of ultrasound-guided superior cluneal nerve block'}]}, 'descriptionModule': {'briefSummary': 'Complete motorsparing protocol (CMP) has been developed to try to minimize the motor nerve block that is created when using Facia iliaca nerve block. The blocks performed in the (CMP) are the cluneal nerve block, Pericapsular nerve group block and lateral femoral cutaneous block. On the clinical trial, the investigators will randomize the participants that meet criteria to CMP or Fascia iliaca Block and compare the amount of opioid needed post op during 24 hours and their pain scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Patients undergoing total hip arthroplasty posterior approach.\n* Patients willing to participate and sign informed consent\n\nExclusion Criteria:\n\n* Severe COPD/other contraindication to general anesthesia that spinal would be more suitable.\n* Patient with a weight of less than 41 kg\n* Dementia, not alert or Oriented to person, place, or time\n* Chronic pain patient with daily opioid use at home.\n* Patient with allergy to local anesthetics\n* Patient refusal\n* Total hip arthroplasty revision\n* Concomitant pain in different area from operative site.\n* Pregnancy\n* Patient with active infection on the injection sites for the blocks\n* Patients unable or willing to understand or comply with the study protocol'}, 'identificationModule': {'nctId': 'NCT04426058', 'briefTitle': 'CMP vs Fascia Iliaca Block', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'Complete Motor Sparing Protocol Versus Fascia Iliaca Suprainguinal Technique for Total Hip Arthroplasty, a Prospective Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '213048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CMP', 'description': 'Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml', 'interventionNames': ['Drug: CMP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fascia iliaca', 'description': 'Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml', 'interventionNames': ['Drug: Fascia Illica']}], 'interventions': [{'name': 'CMP', 'type': 'DRUG', 'description': 'Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml', 'armGroupLabels': ['CMP']}, {'name': 'Fascia Illica', 'type': 'DRUG', 'description': 'Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml', 'armGroupLabels': ['Fascia iliaca']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Byram, MD', 'role': 'CONTACT', 'email': 'sbyram@lumc.edu', 'phone': '713-216-5988'}], 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}], 'centralContacts': [{'name': 'Carlos Martinez Parra, MD', 'role': 'CONTACT', 'email': 'carlos.martinezparra@lumc.edu', 'phone': '(708) 216-6462'}, {'name': 'Michael Majewski, MD', 'role': 'CONTACT', 'email': 'mimajewski@lumc.edu', 'phone': '(708) 216-6462'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Scott Byram MD', 'investigatorAffiliation': 'Loyola University'}}}}