Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-25 @ 1:31 AM
Study NCT ID:
NCT07017192
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of residual femoral and obturator nerves block in the two treatment groups', 'timeFrame': '8 hours after surgery', 'description': '(knee extension and hip adduction according to ASIA score)'}], 'secondaryOutcomes': [{'measure': 'Time elapsed between the end of surgery and the recovery of lower limb motility', 'timeFrame': '8 (or more) hours after surgery', 'description': 'Ability of patient to mobilize independently within the room'}, {'measure': 'Total opioid consumption', 'timeFrame': '8, 24 and 48 hours after surgery', 'description': 'Calculated as morphine equivalents'}, {'measure': 'Pain according to NRS (Numeric Rating Scale)', 'timeFrame': '8, 24 and 48 hours after surgery', 'description': 'Scale 1-10 (1 corresponding to minimum and 10 corresponding to maximum pain perceived)'}, {'measure': 'Extent of sensory block', 'timeFrame': '8, 24 and 48 hours after surgery', 'description': 'Clinical evaluation of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves)'}, {'measure': 'Incidence of postoperative complications', 'timeFrame': 'Up to 48 hrs after surgery', 'description': 'Bleeding, Bradyarrhythmic and/or hypotensive events, Nausea and Vomiting'}, {'measure': 'Timing of hospital discharge', 'timeFrame': 'From enrolment to the first follow up at 30 days'}, {'measure': 'Incidence of chronic or persistent postoperative pain', 'timeFrame': '30 and 90 days after surgery', 'description': 'Follow-up by phone, using Brief Pain Inventory (presence of pain/localization/characteristics) and DN4 (neuropathic component) questionnaires.'}, {'measure': 'Incidence of acute side effects related to opioid use', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'excessive sedation, nausea and vomiting, respiratory depression, pruritus, urinary retention, constipation'}, {'measure': 'Incidence of complications related to nerve blocks', 'timeFrame': 'up to 48 hours after surgery', 'description': 'block failure, nerve damage, hematomas, systemic toxicity from local anesthetics'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Replacement Surgery', 'Hip Replacement, Total', 'Hip Pain', 'Hip Arthroplasty', 'Hip Replacement Postoperative', 'Hip Surgery', 'Pain,Postoperative', 'Mobility and Independence']}, 'descriptionModule': {'briefSummary': 'Main indications for total hip arthroplasty (THA) are degenerative osteoarthritis of the coxofemoral joint, osteonecrosis of the hip, congenital disorders such as dysplasia and inflammatory arthritis. More recently, surgery using the direct anterior approach is getting popularity: this method, in fact, granting a significant sparing of the hip muscles, is associated with favorable results compared to other techniques, such as a lower risk of dislocation, limitated damage to soft tissues with better recovery and early discharge.\n\nPatients undergoing this procedure may although experience moderate to severe postoperative pain in the first few hours (with peaks observed in the first 12 hours), as well as potential complications such as nausea and vomiting related to opioids use.\n\nIt has been shown that adequate pain control influences early mobilization and rehabilitation, ensuring a quicker recovery. The role of regional anesthesia techniques has been established in almost all areas of orthopedic surgery, and in particularly in the management of postoperative pain following hip replacement surgery, but definitive data are missing with regard to direct anterior approach.\n\nRegional anesthesia consists of infiltrating local anesthetics in sites (fascial planes or nerves), in order to limit or even eliminate the use of traditional painkillers, with a significant reduction in the side effects.\n\nThe aim of this study is to compare the impact of two techniques, the Suprainguinal Fascia Iliaca (SIFI) block and the lumbar Erector Spinae Plane (ESP) block, in managing postoperative pain in subjects undergoing total hip replacement surgery performed by direct anterior approach.\n\nThe primary objective of the study is the incidence of residual femoral and obturator nerves block (knee extension and hip adduction according to ASIA score) 8 hours after surgery in the two treatment groups.\n\nSecondary objectives include: • Time elapsed between the end of surgery and the recovery of lower limb motility enough to allow the patient to mobilize independently; • Total opioid consumption (calculated as morphine equivalents) at 8, 24 and 48 hours after surgery; • Pain according to NRS (numerica rating scale) at 8, 24 and 48 hours after surgery; • Extent of sensory block of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves) at 8, 24 and 48 hours after surgery; • Timing of hospital discharge; • Incidence of chronic or persistent postoperative pain (at 30 and 90 days after surgery); • Any postoperative complication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years and =\\<85 years\n* patients undergoing elective unilateral THA with direct anterior approach\n* patients able to understand the purposes of the study and provide signed informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* Age \\<18 years or \\>85 years\n* revision or bilateral surgeries\n* psychiatric pathology or cognitive deficits, mental retardation, inability to provide valid informed consent\n* History of illicit drugs and/or alcohol abuse\n* urgent/emergent surgery with admission to Intensive Care under sedation and mechanical ventilation or complications that do not allow evaluation\n* known allergy to the drugs used in the study\n* refusal to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07017192', 'briefTitle': 'OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study. Regional Anesthesia Techniques for Anterior Approach Hip Arthroplasty Analgesia: SIFI Block Versus Lumbar ESP Block', 'orgStudyIdInfo': {'id': '77/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects udergoing SIFI block', 'interventionNames': ['Procedure: SIFI Block']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects udergoing ESP block', 'interventionNames': ['Procedure: ESP block']}], 'interventions': [{'name': 'SIFI Block', 'type': 'PROCEDURE', 'description': 'Infiltration of local anesthetics in the suprainguinal iliac fascia (Ropivacaine 0.375 40 mls)', 'armGroupLabels': ['Subjects udergoing SIFI block']}, {'name': 'ESP block', 'type': 'PROCEDURE', 'description': 'Infiltration of local anesthetics in the fascial plane underneath the erector spoinae mulscle at lumbar level (Ropivacaine 0.375 40 mls)', 'armGroupLabels': ['Subjects udergoing ESP block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'state': 'TO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Ulla, MD', 'role': 'CONTACT', 'email': 'marco.ulla@gmail.com', 'phone': '+390116933818'}, {'name': 'Cecilia Crosetto, MD', 'role': 'CONTACT', 'email': 'cecilia.crosetto@gmail.com', 'phone': '+390116933818'}, {'name': 'Marco Ulla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Cecilia Crosetto, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cecilia Giordano, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amedeo Burato, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': "Andrea D'Amelio, MD", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chiara Busso, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dario Bugada, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alessandro Massè, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maurizio Berardino, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'AOU Città della Salute e della Scienza', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Marco Ulla, MD', 'role': 'CONTACT', 'email': 'marco.ulla@gmail.com', 'phone': '0039-3397548673'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}