Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:41 AM
Study NCT ID:
NCT07458360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessments will be performed by independent researchers blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 1:1 ratio to receive either an ultrasound-guided unilateral FRONT block plus standard multimodal analgesia or standard multimodal analgesia alone. Outcomes will be compared between the two parallel groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Quality of Recovery (QoR-15 Score)', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery.'}], 'secondaryOutcomes': [{'measure': 'Quality of Recovery (QoR-15) Score at 48 Hours', 'timeFrame': '48 hours after surgery', 'description': 'Quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire (0-150, higher scores indicate better recovery).'}, {'measure': 'Postoperative Pain Intensity', 'timeFrame': '2, 6, 12, 24, and 48 hours after surgery', 'description': 'Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.'}, {'measure': 'Total Opioid Consumption', 'timeFrame': '0-24 hours after surgery', 'description': 'Total postoperative opioid consumption during the first 24 hours will be recorded and converted to intravenous morphine milligram equivalents (MME).'}, {'measure': 'Time to First Rescue Analgesia', 'timeFrame': 'Within the first 24 hours after surgery', 'description': 'Time from the end of surgery to the first rescue opioid administration will be recorded'}, {'measure': 'Time to First Mobilization', 'timeFrame': 'Within the first 48 hours after surgery', 'description': 'Time from the end of surgery to first assisted ambulation will be recorded'}, {'measure': 'Quadriceps Motor Strength', 'timeFrame': '0-48 hours after surgery', 'description': 'Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale ranging from 0 (no contraction) to 5 (normal muscle strength).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Hip', 'Postoperative Pain', 'Quality of Recovery']}, 'descriptionModule': {'briefSummary': 'This prospective randomized controlled trial evaluates the effect of ultrasound-guided unilateral Femoral Rami and Obturator Nerve Trunk (FRONT) block on postoperative quality of recovery in patients undergoing elective total hip arthroplasty.', 'detailedDescription': 'Total hip arthroplasty (THA) is associated with significant postoperative pain that may impair early recovery. The Femoral Rami and Obturator Nerve Trunk (FRONT) block is a regional anesthesia technique targeting sensory innervation of the anterior hip capsule and may improve postoperative recovery while preserving motor function. This prospective randomized controlled trial aims to evaluate whether the addition of ultrasound-guided unilateral FRONT block to standard multimodal analgesia improves postoperative quality of recovery in patients undergoing THA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for total hip arthroplasty under spinal anesthesia\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Ability to understand and complete the QoR-15 questionnaire\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Contraindication to spinal anesthesia or regional block\n* Allergy to study medications\n* Chronic opioid use (daily use for more than 3 months)\n* Neurological or neuromuscular disorders affecting the lower extremities\n* Infection at the injection site\n* Coagulation disorders\n* Cognitive impairment prevents questionnaire completion'}, 'identificationModule': {'nctId': 'NCT07458360', 'briefTitle': 'FRONT Block for Quality of Recovery After Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Konya Meram State Hospital'}, 'officialTitle': 'Effect of Femoral Rami and Obturator Nerve Trunk (FRONT) Block on Postoperative Quality of Recovery After Total Hip Arthroplasty: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FRONT BLOCK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FRONT Block Group', 'description': 'Participants in this group will receive an ultrasound-guided unilateral Femoral Rami and Obturator Nerve Trunk (FRONT) block in addition to standardized multimodal postoperative analgesia.', 'interventionNames': ['Procedure: FRONT Block (Femoral Rami and Obturator Nerve Trunk Block)', 'Procedure: Standard Multimodal Analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in this group will receive standardized multimodal postoperative analgesia without FRONT block.', 'interventionNames': ['Procedure: Standard Multimodal Analgesia']}], 'interventions': [{'name': 'FRONT Block (Femoral Rami and Obturator Nerve Trunk Block)', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided unilateral FRONT block targeting the femoral rami and obturator nerve trunk will be performed', 'armGroupLabels': ['FRONT Block Group']}, {'name': 'Standard Multimodal Analgesia', 'type': 'PROCEDURE', 'description': 'Standardized postoperative multimodal analgesia including intravenous paracetamol, nonsteroidal anti-inflammatory drugs, and rescue opioid analgesia as required.', 'armGroupLabels': ['Control Group', 'FRONT Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42005', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Betul Kozanhan', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Meram State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Betul Kozanhan', 'investigatorAffiliation': 'Konya Meram State Hospital'}}}}