[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657004":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":42,"studyPopulation":30,"armGroups":43,"interventions":70,"overallOfficials":30,"centralContacts":105,"locations":111,"responsibleParty":124,"collaborators":30,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":30,"eligibilityCriteria":131,"healthyVolunteers":128,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":30,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":151,"whyStopped":30,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Poznan University of Physical Education","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Total mILOA\u002FmILAS score","Total score on the modified mILOA\u002FmILAS functional independence scale, ranging from 0 to 36 points, with lower scores indicating greater functional independence. The assessment will be performed by a physiotherapist blinded to treatment allocation.","6 months",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Hierarchical Timed Up and Go (TUG) outcome","Functional mobility assessed using a hierarchical TUG outcome at approximately 24 hours after surgery.","6 months (November 2026 -April 2027)",{"measure":19,"description":20,"timeFrame":17},"Time from completion of surgery to the first independent 10-meter walk","Time elapsed from the end of surgery until the participant is able to independently walk 10 meters, with or without an assistive device, according to the predefined study criteria.",{"measure":22,"description":23,"timeFrame":17},"Total mILOA\u002FmILAS score at 6 and 48 hours","Functional independence assessed using the modified mILOA\u002FmILAS scale (0-36 points), with lower scores indicating greater functional independence.",{"measure":25,"description":26,"timeFrame":17},"Quadriceps muscle strength","The strength of the quadriceps muscle following surgery was assessed using a dynamometer",{"measure":28,"description":29,"timeFrame":17},"Numeric Rating Scale (NRS) pain score during movement","Pain intensity during standardized movement assessed using the 0-10 Numeric Rating Scale, with higher scores indicating greater pain.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Participants will be randomized in a parallel-group design to receive either the active nerve block or a control procedure. Patients undergoing total hip arthroplasty (THA) will receive a single preoperative PENG block, while patients undergoing total knee arthroplasty (TKA) will receive a single preoperative adductor canal block (ACB). Control participants will undergo an identical ultrasound-guided procedure without injection into the target compartment. All participants will receive standardized multimodal perioperative analgesia, and patients undergoing TKA will receive identical intraoperative local infiltration analgesia. Participants will remain in their assigned study group throughout the study.","TREATMENT",{"masking":37,"maskingDescription":38,"whoMasked":39},"DOUBLE","The study will be a prospective, single-centre, randomised, controlled superiority trial with two parallel groups, a 1:1 allocation ratio, and blinding of the patient, the assessing physiotherapist and the data analysis team",[40,41],"PARTICIPANT","OUTCOMES_ASSESSOR","The planned study will be a prospective, randomized, controlled clinical trial with blinded outcome assessment, designed to evaluate the effect of a single preoperative ultrasound-guided peripheral nerve block on early functional independence in patients undergoing elective primary unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA) for osteoarthritis.\n\nAdults scheduled for elective primary unilateral THA or TKA who are able to walk at least 10 meters with or without an assistive device before surgery will be eligible for inclusion. Patients will be randomly allocated to either an intervention group or a control group. The intervention will depend on the type of surgery: patients undergoing THA will receive a single preoperative pericapsular nerve group (PENG) block, whereas patients undergoing TKA will receive a single preoperative adductor canal block (ACB). Both procedures will be performed under ultrasound guidance, using a dose of ropivacaine predefined and limited by the study safety protocol.\n\nPatients in the control group will undergo identical preparation and an ultrasound-guided procedure; however, the needle will not be advanced into the target compartment and no study drug will be administered into the target space. This approach is intended to maintain comparable procedural conditions and minimize the potential influence of patient and staff expectations on study outcomes. Both groups will receive standardized multimodal perioperative analgesia. In the TKA population, both groups will additionally receive identical intraoperative local infiltration analgesia (LIA).\n\nStudy Objective The primary objective of the study will be to determine whether a single preoperative PENG block in patients undergoing THA and an ACB in patients undergoing TKA improves early postoperative functional independence compared with the control intervention.\n\nThe primary endpoint will be the total score on the modified mILOA\u002FmILAS scale, assessed 24 ± 3 hours after completion of surgery. The scale ranges from 0 to 36 points, with lower scores indicating greater functional independence. The assessment will be performed by a physiotherapist who is blinded to the patient's treatment allocation.\n\nSecondary Outcomes\n\nKey secondary outcomes will include:\n\nhierarchical Timed Up and Go (TUG) outcome at 24 hours after surgery; time from completion of surgery to the first independent 10-meter walk; mILOA\u002FmILAS score at 6 and 48 hours; TUG performance at hospital discharge; effectiveness and quality of the scheduled physiotherapy session; postoperative quadriceps muscle strength; pain intensity assessed using the numerical rating scale (NRS), particularly during movement; total postoperative opioid consumption; incidence and nature of adverse events related to the study intervention; time to readiness for hospital discharge. Follow-up Patient follow-up will begin at the preoperative visit and continue until postoperative day 90. The primary assessment of treatment efficacy will be performed at 24 ± 3 hours after completion of surgery. Additional functional assessments will be performed at predefined time points during the first 48 postoperative hours and at hospital discharge. During the 90-day follow-up period, data regarding postoperative recovery and clinically relevant postoperative events will be collected.\n\nStatistical Analysis The primary efficacy analysis will follow the intention-to-treat principle and will include all randomized patients according to their assigned treatment group. The primary endpoint will be analyzed using a linear regression model with robust standard errors. The model will be adjusted for type of surgery (THA\u002FTKA), study center, and baseline TUG performance.\n\nThe primary treatment effect measure will be the adjusted mean difference in the mILOA\u002FmILAS score between the intervention and control groups, reported together with a 95% confidence interval. The direction of the effect will be interpreted according to the scale characteristics, whereby a lower mILOA\u002FmILAS score indicates greater functional independence.\n\nSensitivity analyses will be performed to assess the robustness of the findings to the underlying analytical assumptions. These will include an ordinal regression model and an appropriate stratified test. Detailed procedures for handling missing data and any per-protocol analyses will be prespecified in the statistical analysis plan.\n\nClinical Relevance The study is designed to determine whether targeted single-shot peripheral nerve blocks administered before surgery can improve early functional recovery after THA and TKA without compromising safety or the patient's ability to participate effectively in postoperative rehabilitation. Particular emphasis will be placed on functional independence rather than pain control alone, as early restoration of mobility is a key component of contemporary postoperative care following joint arthroplasty.\n\nThe study design distinguishes the intervention according to the type of surgery: the PENG block will be evaluated in patients undergoing THA, whereas the ACB will be evaluated in patients undergoing TKA. Identical procedural preparation in the control group, blinded outcome assessment, and standardized analgesic management are intended to minimize the risk of systematic bias and improve the reliability of the assessment of the effects of the study interventions on early postoperative functional recovery.",[44,54,60,65],{"label":45,"type":46,"description":47,"interventionNames":48},"THA - PENG Block","EXPERIMENTAL","Patients undergoing total hip replacement receive a single pre-operative ultrasound-guided PENG block with ropivacaine.",[49,50,51,52,53],"Procedure: PENG Block with Ropivacaine","Drug: Subarachnoid anesthesia","Drug: Pain Reliever","Drug: Anti Inflammatory Drug","Procedure: physical rehabilitation",{"label":55,"type":56,"description":57,"interventionNames":58},"THA - Control","ACTIVE_COMPARATOR","Patients undergoing total hip arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia.",[59,50,51,52,53],"Procedure: Sham PENG Block",{"label":61,"type":46,"description":62,"interventionNames":63},"TKA - Adductor Canal Block","Patients undergoing total knee arthroplasty receive a single preoperative ultrasound-guided adductor canal block with ropivacaine.",[64,50,51,52,53],"Procedure: Adductor Canal Block with Ropivacaine",{"label":66,"type":56,"description":67,"interventionNames":68},"TKA - Control","Patients undergoing total knee arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia and identical intraoperative LIA.",[69,50,51,52,53],"Procedure: Sham Adductor Canal Block",[71,76,80,84,88,93,97,101],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":30},"PROCEDURE","PENG Block with Ropivacaine","A single preoperative ultrasound-guided pericapsular nerve group (PENG) block performed in patients undergoing primary unilateral total hip arthroplasty, using ropivacaine at a dose specified by the study safety protocol.",[45],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":30},"Sham PENG Block","An ultrasound-guided sham procedure performed using identical patient preparation and ultrasound visualization, without needle insertion into the target compartment or administration of study drug into the target space. Participants receive standard multimodal perioperative analgesia.",[55],{"type":72,"name":81,"description":82,"armGroupLabels":83,"otherNames":30},"Adductor Canal Block with Ropivacaine","A single preoperative ultrasound-guided adductor canal block performed in patients undergoing primary unilateral total knee arthroplasty, using ropivacaine at a dose specified by the study safety protocol.",[61],{"type":72,"name":85,"description":86,"armGroupLabels":87,"otherNames":30},"Sham Adductor Canal Block","An ultrasound-guided sham procedure performed using identical patient preparation and ultrasound visualization, without needle insertion into the target compartment or administration of study drug into the target space. Participants receive standard multimodal perioperative analgesia and identical intraoperative local infiltration analgesia.",[66],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":30},"DRUG","Subarachnoid anesthesia","hyperbaric bupivacaine \\[8-12.5 mg\\] without intrathecal opioid; propofol sedation to a RASS score of 0 to -2.",[55,45,61,66],{"type":89,"name":94,"description":95,"armGroupLabels":96,"otherNames":30},"Pain Reliever","Paracetamol 1 g every 6 hours (max. 4 g\u002Fday; lower dose as indicated) and celecoxib\u002FNSAID in accordance with local practice, provided there are no contraindications.",[55,45,61,66],{"type":89,"name":98,"description":99,"armGroupLabels":100,"otherNames":30},"Anti Inflammatory Drug","Intravenous dexamethasone, up to 10 mg as a single dose during surgery, provided there are no contraindications.",[55,45,61,66],{"type":72,"name":102,"description":103,"armGroupLabels":104,"otherNames":30},"physical rehabilitation","The first attempt at mobilization is scheduled for 4-6 hours after the end of surgery. Antithrombotic exercises, attempts at sitting up and walking.",[55,45,61,66],[106],{"name":107,"role":108,"phone":109,"phoneExt":30,"email":110},"Sabina SK Kaczmarczyk, phd student","CONTACT","0048 570 707 222","iskra@awf.poznan.pl",[112],{"facility":113,"status":30,"city":114,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":30},"Poznań University of Physical Education","Poznan","61-871","Poland","PL",{"type":119,"coordinates":120},"Point",[121,122],16.92993,52.40692,{"lat":122,"lon":121},{"type":125,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100657004","the-impact-of-regional-motor-sparing-blocks-on-early-rehabilitation-following-primary-hip-or-knee-arthroplasty-100657004",false,"NCT07834619","The Impact of Regional Motor-sparing Blocks on Early Rehabilitation Following Primary Hip or Knee Arthroplasty","Inclusion Criteria\n\n* Scheduled for elective primary unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA) due to osteoarthritis.\n* Planned spinal anesthesia according to the study protocol.\n* Ability to walk at least 10 meters before surgery, with or without an assistive device.\n* Ability to understand and follow the instructions for the mILOA\u002FmILAS and Timed Up and Go (TUG) assessments.\n* Provision of written informed consent.\n\nExclusion Criteria\n\n* Revision arthroplasty, simultaneous bilateral arthroplasty, or arthroplasty performed due to fracture, tumor, or infection.\n* Contraindication to the study nerve block, ropivacaine, spinal anesthesia, or any mandatory component of the analgesic regimen.\n* Coagulopathy or anticoagulant therapy incompatible with current recommendations for peripheral nerve blocks or neuraxial anesthesia.\n* Infection at the planned needle insertion site.\n* Significant preoperative neurological deficit of the operated limb that would preclude reliable assessment of mobility.\n* Opioid use disorder or chronic opioid use of ≥30 mg oral morphine equivalent per day for more than 3 months.\n* Participation in another interventional clinical trial that could affect postoperative rehabilitation.\n* Inability to ensure assessment of the primary endpoint within the required time window.","ALL","65 Years","100 Years",{"count":136,"type":137},220,"ESTIMATED","INTERVENTIONAL",[140],"NA","The purpose of this study is to determine whether a single nerve block given before surgery can help patients regain independence and mobility more quickly after planned hip or knee replacement surgery for osteoarthritis.\n\nPatients undergoing hip replacement will receive a PENG block, while patients undergoing knee replacement will receive an adductor canal block (ACB). Both procedures will be performed using ultrasound guidance. Some patients will receive a control procedure instead of the active nerve block. All participants will receive standard pain treatment and postoperative rehabilitation.\n\nThe main aim of the study is to compare patients' functional independence approximately 24 hours after surgery. Other outcomes will include the ability to walk independently, performance during physiotherapy, muscle strength, pain intensity, opioid use, adverse events, and readiness for hospital discharge. Participants will be followed from the preoperative visit until 90 days after surgery.\n\nThe results of this study may help determine whether these nerve blocks are a safe and effective way to support early recovery and restoration of mobility after hip or knee replacement surgery.",[143,144,145],"Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA)","Preoperative Adductor Canal Block (ACB)","Preoperative Pericapsular Nerve Group (PENG)",[147,148,149,150],"preoperative pericapsular nerve group (PENG)","hip arthroplasty (THA)","knee arthroplasty","preoperative adductor canal block (ACB)","NOT_YET_RECRUITING","2026-09-16",{"date":154,"type":155},"2026-09-22","ACTUAL",{"date":157,"type":137},"2026-09-08",{"date":159,"type":137},"2027-05",{"name":5,"class":6},1]