[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591607":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Institut Mutualiste Montsouris","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SIFIB group","EXPERIMENTAL","The ultrasound probe is placed in a cephalo-caudal orientation, over the inguinal ligament, lateral to the femoral nerve. The iliacus muscle, which is covered caudally by the sartorius muscle and cephalically by the internal oblique muscle, is visualized in depth. Between these two muscles, an area is identified where the iliacus muscle is covered only by subcutaneous tissue. The needle is introduced in a cranio-caudal direction, and the injection is initiated in this area, beneath the fascia iliaca. The needle then advances through the space created by the injection, as far as possible in a cephalic direction, beneath the internal oblique muscle. An injection of 40 ml of 0.1% ropivacaine is administered.",[13,14],"Procedure: Ultrasound guided supra inguinal fascia iliaca block","Procedure: Surgical and anesthetic protocol",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo group","SHAM_COMPARATOR","Five milliliters of saline are injected subcutaneously under ultrasound guidance",[20,14],"Procedure: Placebo Injection",[22,27,30],{"type":23,"name":24,"description":11,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Ultrasound guided supra inguinal fascia iliaca block",[9],null,{"type":23,"name":28,"description":18,"armGroupLabels":29,"otherNames":26},"Placebo Injection",[16],{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":26},"Surgical and anesthetic protocol","All patients receive standard general anesthesia:\n\n* Induction of anesthesia by sufentanil, ketamine, propofol and tracrium if needed,\n* Maintenance of anesthesia by sevoflurane and sufentanil if needed,\n* Prevention of PONV by dexamethasone and droperidol,\n* Post-operative analgesia by paracetamol, ketoprofene, nefopam, as indicated. Total hip arthroplasty is performed by anterior or postero-lateral approach, depending on surgeon preference.\n\nIn the post-anesthesia care unit, if numerical pain rating scale at rest is \\>=4, patients are randomized to receive experimental or placebo intervention.",[16,9],[35],{"name":36,"affiliation":5,"role":37},"Abderrahmen BARGAOUI, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Chahrazad Bey Boumezrag","CONTACT","+33 156616983","chahrazad.beyboumezrag@imm.fr",[45],{"facility":5,"status":46,"city":47,"state":26,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Paris","75014","France","FR",{"type":52,"coordinates":53},"Point",[54,55],2.3488,48.85341,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":26,"phoneExt":26,"email":26},"Abderrahmen Bargaoui, Dr",{"type":37,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Abderrahmen BARGAOUI","Principal Investigator","100591607","supra-inguinal-fascia-iliaca-block-as-rescue-analgesia-following-total-hip-arthroplasty-100591607",false,"NCT06982625","Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty","SOSBIFSI","Inclusion Criteria:\n\n* patient scheduled for a primary total hip arthroplasty under general anesthesia,\n* written informed consent.\n\nNon inclusion criteria:\n\n* contra indication to ropivacaine\n* vulnerable person\n\nExclusion Criteria:\n\n* per-operative complication making wheight-bearing and walking contra-indicated.\n* patient without significant pain post-operatively.","ALL","18 Years",{"count":73,"type":74},310,"ESTIMATED","INTERVENTIONAL",[77],"NA","Hip replacement surgery is one of the most commonly performed surgical procedures in France, with approximately 150,000 procedures per year. Postoperative recovery has significantly improved in recent years, enabling faster rehabilitation.\n\nAlthough generally considered moderately painful, hip replacement surgery can, in some difficult-to-predict cases, lead to severe postoperative pain, requiring high doses of morphine, which may cause side effects and delay recovery.\n\nIn other surgical procedures, regional anesthesia (nerve blocks) has been successfully used for pain relief. However, its effectiveness after hip replacement surgery has not yet been fully proven.\n\nA recent regional anesthesia technique-the Supra-Inguinal Fascia Iliaca Block (SIFIB)-which numbs a significant portion of the nerves around the hip, has recently been developed.\n\nWhen performed in all patients undergoing hip arthroplasty, the benefit of this technique could not be demonstrated. In addition, this technique may lead to transcient muscle blockade, wich also can delay recovery.\n\nIn order to limit the use of nerve blocks to painful patients, we designed this study where the nerve block is performed only in patients experiencing significant paint after surgery.\n\nIn conclusion, this study aims to assess the benefits of performing a rescue SIFIB in the recovery room for patients who experience significant postoperative pain after hip replacement surgery. The evaluation will focus on pain relief and ability to walk.\n\nNo new treatment is being tested. The technique uses a commonly administered local anesthetic to numb the nerves.",[80,81,82],"Hip Arthroplasty, Total","Post Operative Pain, Acute","Nerve Block",[84,85,86,87,88,89,90],"Total hip arthroplasty","Regional anesthesia","Nerve blocks","Supra-inguinal fascia iliaca block","Enhanced recovery after surgery","Acute post-operative pain","Rescue analgesia","2025-09-22",{"date":93,"type":94},"2025-09-25","ACTUAL",{"date":91,"type":94},{"date":97,"type":74},"2027-12-31",{"name":5,"class":6},1]