[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627812":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":26,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University College Hospital Galway","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group (Psoas Sheath Block)","EXPERIMENTAL","Intervention group: Psoas sheath Block\n\nParticipants in the psoas sheath block arm will receive a psoas sheath block preoperatively under direct ultrasound guidance as follows:\n\nPreparation:\n\nStandard skin sterilisation, prepping, and draping will be applied to the block area.\n\nUltrasound Guidance:\n\nAnatomical landmarks will be identified using a curvilinear low-frequency (2-5 MHz) ultrasound probe.\n\nLocal Anaesthetic Administration:\n\nA 22 G, 100mm needle will be inserted using the in-plane technique and advanced to the target site.\n\nA bolus of 40 ml of 0.375% ropivacaine will be injected into the subpsoas fascial plane.\n\nThe procedure will be performed by experienced anaesthesiologists to ensure accuracy and safety.",[13],"Procedure: Psoas Sheath Block",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group (Suprainguinal Fascia Iliaca Block)","ACTIVE_COMPARATOR","Control group: Fascia Iliaca Compartment Block\n\nParticipants in the fascia iliaca compartment block arm will receive a fascia iliaca block preoperatively under direct ultrasound guidance as follows:\n\nPreparation:\n\nStandard skin sterilisation, prepping, and draping will be applied to the block area.\n\nUltrasound Guidance:\n\nAnatomical landmarks will be identified using a linear high-frequency (6-13 MHz) ultrasound probe.\n\nLocal Anaesthetic Administration:\n\nA 22 G, 50 mm needle will be inserted using the in-plane technique and advanced beneath the fascia iliaca.\n\nA bolus of 40 ml of 0.375% ropivacaine will be injected into the fascia iliaca compartment.\n\nThe procedure will be performed by experienced anaesthesiologists to ensure accuracy and safety.\n\nDose adjustments will be made if the patient weighs \\\u003C50kg to reduce the risk of local anaesthetic systemic toxicity.",[19],"Procedure: Suprainguinal Fascia Iliaca",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Psoas Sheath Block","Intervention group: Subpsoas Fascial Plane Block\n\nParticipants in the subpsoas fascial plane block arm will receive a psoas sheath block preoperatively under direct ultrasound guidance as follows:\n\nPreparation:\n\nStandard skin sterilisation, prepping, and draping will be applied to the block area.\n\nUltrasound Guidance:\n\nAnatomical landmarks will be identified using a curvilinear low-frequency (2-5 MHz) ultrasound probe.\n\nLocal Anaesthetic Administration:\n\nA 22 G, 100mm needle will be inserted using the in-plane technique and advanced to the target site.\n\nA bolus of 40 ml of 0.375% ropivacaine will be injected into the subpsoas fascial plane.\n\nThe procedure will be performed by experienced anaesthesiologists to ensure accuracy and safety",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Suprainguinal Fascia Iliaca","Fascia Iliaca Compartment Block\n\nParticipants in the fascia iliaca compartment block arm will receive a fascia iliaca block preoperatively under direct ultrasound guidance as follows:\n\nPreparation:\n\nStandard skin sterilisation, prepping, and draping will be applied to the block area.\n\nUltrasound Guidance:\n\nAnatomical landmarks will be identified using a linear high-frequency (6-13 MHz) ultrasound probe.\n\nLocal Anaesthetic Administration:\n\nA 22 G, 50 mm needle will be inserted using the in-plane technique and advanced beneath the fascia iliaca.\n\nA bolus of 40 ml of 0.375% ropivacaine will be injected into the fascia iliaca compartment.\n\nThe procedure will be performed by experienced anaesthesiologists to ensure accuracy and safety.\n\nDose adjustments will be made if the patient weighs \\\u003C50kg to reduce the risk of local anaesthetic systemic toxicity.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Anna L Horgan, MC BCh BAO FCAI","CONTACT","+353857848200","annahorgan2@gmail.com",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Merlin Park Hospital, Galway","RECRUITING","Galway","Ireland","IE",{"type":45,"coordinates":46},"Point",[47,48],-9.05095,53.27245,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":35,"phoneExt":26,"email":36},"Anna L Horgan, MB BCh BAO FCAI",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","John Laffey","Professor John Laffey MD, DSc","100627812","evaluating-the-efficacy-of-the-psoas-sheath-block-for-post-operative-analgesia-following-hip-arthroplasty-100627812",false,"NCT07453498","Evaluating the Efficacy of the Psoas Sheath Block for Post Operative Analgesia Following Hip Arthroplasty","Inclusion Criteria:\n\n* Participants aged \\>18\n* Patients scheduled to undergo elective unilateral total hip replacement (THR) surgery.\n* Patients who agree to receive regional anaesthetic blocks as part of their post-operative pain management.\n* Physical Status: ASA (American Society of Anesthesiologists) physical status classification I-III.\n* Patients who are willing and able to provide informed consent, demonstrating an understanding of the trial's purpose, methods, and potential risks.\n* Patients who are willing to comply with assessments post-surgery\n\nExclusion Criteria:\n\n* Allergy to Study Medications\n* History of chronic opioid use (\\>50mg of oral morphine equivalents per day.\n* Any neurological condition affecting the lower extremities (e.g., peripheral neuropathy, radiculopathy) that could interfere with pain assessment or recovery evaluation.\n* Infection at Injection Site\n* Coagulopathy or Anticoagulant Use: Patients with coagulopathy (INR \\>1.5) or who are on anticoagulant therapy that cannot be safely discontinued for the block procedure.\n* Severe Respiratory or Cardiovascular Disease: Any severe respiratory or cardiovascular disease (e.g., severe chronic obstructive pulmonary disease, heart failure) that may increase perioperative risk and complicate recovery.\n* Cognitive impairment or conditions (e.g., dementia with MMSE \\\u003C24) that would prevent reliable pain reporting or compliance with post-operative assessments","ALL","18 Years",{"count":66,"type":67},130,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study will be a single-centre, assessor-blind, randomised controlled trial to compare the efficacy of the psoas sheath block (experimental group) with the suprainguinal fascia iliaca plane block (control group) in patients undergoing total hip arthroplasty\n\nParticipants will be randomly assigned to one of two groups (psoas sheath block or Fascia Iliaca block) using a computer-generated random number sequence. The allocation will be concealed in opaque, sealed envelopes.\n\nThe assessor will be blinded to the group allocation to ensure unbiased outcome assessment",[73],"Total Hip Arthroplasty (THA)",[75,23,76],"Total Hip Arthroplasty","Regional anaesthesia","2026-03-02",{"date":79,"type":80},"2026-03-06","ACTUAL",{"date":82,"type":80},"2025-11-18",{"date":84,"type":67},"2027-11-18",{"name":5,"class":6},1]