Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:33 AM
Study NCT ID:
NCT07316166
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-24', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-31', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of administration of first analgesic after the surgery', 'timeFrame': 'Time to first analgesic request, defined as the interval (in minutes) from block administration to the first request for rescue analgesia, assessed for up to 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Total opioid consumption (converted to morphine milligram equivalents)', 'timeFrame': 'From the start of surgery through 48 hours postoperatively', 'description': 'Intraoperative period; PACU; and at 6, 12, 24, and 48 hours following surgery.'}, {'measure': 'Quality of Recovery', 'timeFrame': '24 hours', 'description': "The QoR-15 questionnaire has 15 questions that assess patient-reported quality of a patient's postoperative recovery using a 11-point numerical rating scale that leads to a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery)."}, {'measure': 'Pain Scores', 'timeFrame': 'Up to two hours [post anesthesia recovery unit], 6 hours, 12 hours, 24 hours and 48 hours after surgery', 'description': 'Patients will be asked to rate their pain score on a 11-point scale (0 = no pain to 10 = excruciating pain).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Surgery', 'Nerve block'], 'conditions': ['Postoperative Pain Management']}, 'referencesModule': {'references': [{'pmid': '36813032', 'type': 'BACKGROUND', 'citation': 'Fernandez Martin MT, Alvarez Lopez S, Aldecoa Alvarez-Santullano C. Role of adjuvants in regional anesthesia: A systematic review. Rev Esp Anestesiol Reanim (Engl Ed). 2023 Feb;70(2):97-107. doi: 10.1016/j.redare.2021.06.006. Epub 2023 Feb 20.'}, {'pmid': '38057762', 'type': 'BACKGROUND', 'citation': 'Chen A, Duan W, Hao R, Wang C, Xu X. Ultrasound-guided dexmedetomidine combination with modified high fascia iliaca compartment block for arthroscopic knee surgery: what is the optimal dose of dexmedetomidine? BMC Anesthesiol. 2023 Dec 6;23(1):400. doi: 10.1186/s12871-023-02361-0. Erratum In: BMC Anesthesiol. 2023 Dec 22;23(1):421. doi: 10.1186/s12871-023-02391-8.'}, {'pmid': '28059869', 'type': 'BACKGROUND', 'citation': 'Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.'}, {'pmid': '17403800', 'type': 'BACKGROUND', 'citation': 'Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are evaluating postoperative outcomes in patients undergoing hip replacement surgery performed with either spinal or general anesthesia, who also receive a suprainguinal fascia iliaca block using either perineural ropivacaine alone or ropivacaine combined with dexmedetomidine.', 'detailedDescription': 'Patients undergoing hip replacement surgery often receive a single-shot suprainguinal fascia iliaca block as a part of the primary anesthetic and multimodal postoperative analgesic strategy. However, the analgesic effect of a single-shot block typically diminishes after several hours and may be inconsistent beyond 24 hours. Adding dexmedetomidine, an alpha-2 agonist, to the local anesthetic has been shown to prolong block duration and reduce postoperative opioid requirements. Investigating its use in suprainguinal fascia iliaca blocks for total hip arthroplasty may clarify its clinical effectiveness. The investigators hypothesize that patients receiving ropivacaine with dexmedetomidine will have a significantly longer time to first analgesic request compared to those receiving ropivacaine alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective total hip arthroplasty\n* 18-80 years old\n* ASA 1-3 classifications\n\nExclusion Criteria:\n\n* ASA classification of 4 or greater\n* Infection at the site of nerve blockade\n* Coagulopathy\n* Known allergy to study medications\n* Chronic opioid consumption (\\>3 months)\n* Currently using lidocaine patches\n* Pre-existing neuropathy\n* A history of CVA\n* High grade atrioventricular block (cardiac conduction system impairment)\n* Organ dysfunction (cardiac failure, respiratory failure, end stage renal disease, hepatic dysfunction, hypoalbuminemia)\n* Morbid obesity (≥40 kg/m2)\n* Prior surgery in supra and/or infrainguinal region\n* Non-English-speaking participants'}, 'identificationModule': {'nctId': 'NCT07316166', 'briefTitle': 'Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'Comparison of Suprainguinal Fascia Iliac Block With and Without Dexmedetomidine as an Adjunct to Ropivacaine for Postoperative Analgesia Following Hip Surgery: a Randomized, Double-blinded Study.', 'orgStudyIdInfo': {'id': '2264738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine', 'description': '30 ml of 0.25% ropivacaine; No dexmedetomidine', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Ropivacaine plus Dexmedetomidine', 'description': '30 ml of 0.25% ropivacaine; 1 mcg/kg of dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Ropivacaine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Participants in the experimental arm receive a preoperative suprainguinal fascia iliaca block consisting of 30 mL of 0.25% ropivacaine combined with perineural dexmedetomidine at a dose of 1 mcg/kg.', 'armGroupLabels': ['Ropivacaine plus Dexmedetomidine']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'In the experimental arm, ropivacaine (30 mL of 0.25%) is administered with dexmedetomidine.\n\nIn the active comparator arm, ropivacaine (30 mL of 0.25%) is administered alone without any dexmedetomidine medication.', 'armGroupLabels': ['Ropivacaine', 'Ropivacaine plus Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Renee Dupre', 'role': 'CONTACT', 'email': 'rdupre@brownhealth.org', 'phone': '401-793-4575'}, {'name': 'Mark Kendall, M.D.', 'role': 'CONTACT', 'email': 'mark.kendall@brownhealth.org', 'phone': '401-444-4722'}], 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Vendhan Ramanujam, M.D.', 'role': 'CONTACT', 'email': 'vramanujam@brownhealth.org', 'phone': '401-444-5172'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vendhan Ramanujam', 'investigatorAffiliation': 'Rhode Island Hospital'}}}}