[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584244":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":63,"studyPopulation":50,"armGroups":64,"interventions":77,"overallOfficials":89,"centralContacts":94,"locations":100,"responsibleParty":127,"collaborators":50,"id":129,"slug":50,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":50,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":50,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":102,"whyStopped":50,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Women's College Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative Opioid Consumption","Total opioid dose administered to each patient, converted to oral morphine equivalents.","The first 24 hours after surgery",[14,17,21,25,28,31,34,38,42,46],{"measure":15,"description":16,"timeFrame":12},"Area Under the Curve for Postoperative Pain","Area under the curve calculated from discrete Numeric Rating Scale evaluations of postoperative pain (0 - 10), where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable. Pain will be measured on this scale at 0, 6, 12, 18, and 24 hours after surgery.",{"measure":18,"description":19,"timeFrame":20},"Quality of Recovery","Quality of recovery evaluated using the QoR-15 scale (0 - 150), where 0 represents extremely poor recovery and 150 represents excellent recovery.","At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery",{"measure":22,"description":23,"timeFrame":24},"Postoperative Pain Score","Measured using the Numeric Rating (NRS) Scale (0 - 10) where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable.","At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery.",{"measure":26,"description":27,"timeFrame":12},"Intraoperative Opioid Consumption","Measurement of opioids administered during surgery, converted into oral morphine equivalents.",{"measure":29,"description":30,"timeFrame":12},"Time to Analgesic Request","Length of time until the patient's first request for analgesics following surgery.",{"measure":32,"description":33,"timeFrame":12},"Time to Discharge","The length of time each patient stays in Phase I (Postanesthesia Care Unit) and Phase II (Surgical Day Care) after surgery.",{"measure":35,"description":36,"timeFrame":37},"Adverse Events Attributable to Popliteal Block","The incidence of adverse events possibly attributable to popliteal nerve block, including peripheral nerve injury, hematoma, and infection.","At 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery",{"measure":39,"description":40,"timeFrame":41},"Adverse Events Attributable to Opioids","The incidence of opioid-related side effects, including sedation, pruritis, nausea\u002Fvomiting, and respiratory depression.","Evaluated at 24 and 48 hours after surgery.",{"measure":43,"description":44,"timeFrame":45},"Pain, fatigue, and physical function","Measured using the Achilles tendon Total Rupture Score (ATRS)","Prior to surgery and 1-year post-surgery",{"measure":47,"description":48,"timeFrame":49},"Neuropathic pain","Measured using the English version of the Douleur Neuropathique 4 (DN4) Questionnaire","At 1 week and 1-year post-surgery",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":54,"primaryPurpose":55,"observationalModel":50,"timePerspective":50,"maskingInfo":56},"RANDOMIZED","PARALLEL","This study will be a prospective, double-blinded, randomized controlled superiority trial with two parallel arms.","TREATMENT",{"masking":57,"maskingDescription":58,"whoMasked":59},"TRIPLE","As noted above, only the individual administering the intervention will be aware of allocation assignment. The participant and outcomes assessors will be blinded to minimize bias.",[60,61,62],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This will be a prospective, double-blinded, randomized controlled superiority trial conducted at Women's College Hospital (WCH). The study aims to enroll 80 patients (40 per group) undergoing ambulatory surgical repair of acute Achilles tendon ruptures.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Popliteal nerve (PN) block group","EXPERIMENTAL","30 mL of 0.5% ropivacaine with 2.5 µg\u002Fml of epinephrine",[70],"Procedure: Popliteal Nerve Block",{"label":72,"type":73,"description":74,"interventionNames":75},"Placebo Nerve Block","SHAM_COMPARATOR","1 mL of saline",[76],"Procedure: Sham Block",[78,85],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"PROCEDURE","Popliteal Nerve Block","Under ultrasound guidance, a 22G, 80-mm echogenic needle (SonoTAP II, Pajunk Medical Systems, USA) will be inserted using an in-plane lateral-to-medial approach. 30 mL of 0.5% ropivacaine with 2.5 µg\u002Fml of epinephrine will be deposited between tibial and common peroneal nerves within the paraneural sheath. Adequate spread of local anesthetics will be confirmed by visualization of paraneural spread.",[66],[84],"Popliteal Sciatic Nerve Block",{"type":79,"name":86,"description":87,"armGroupLabels":88,"otherNames":50},"Sham Block","Patients in the Control group will receive sham blocks using a 25G needle to inject 1 mL of saline subcutaneously in the same location (popliteus of the surgical knee). Sterilization and ultrasound scanning will match actual PN block. Such a non-invasive placebo allows maintaining patient blinding, while reducing the risks associated with high-volume placebo nerve block injections. The ultrasound screen will be blinded from the patient's vision for all patients in the trial to prevent unblinding by patients with knowledge of the technique.",[72],[90],{"name":91,"affiliation":92,"role":93},"Richard Brull, MD, FRCPC","University Health Network, Toronto","PRINCIPAL_INVESTIGATOR",[95],{"name":96,"role":97,"phone":98,"phoneExt":50,"email":99},"Didem Bozak","CONTACT","416-323-6008","didem.bozak@wchospital.ca",[101],{"facility":5,"status":102,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"RECRUITING","Toronto","Ontario","M5S 1B2","Canada","CA",{"type":109,"coordinates":110},"Point",[111,112],-79.39864,43.70643,{"lat":112,"lon":111},[115,116,118,121,123,125],{"name":96,"role":97,"phone":98,"phoneExt":50,"email":99},{"name":117,"role":93,"phone":50,"phoneExt":50,"email":50},"Richard Brull, MD,FRCPC",{"name":119,"role":120,"phone":50,"phoneExt":50,"email":50},"Connor TA Brenna, MD","SUB_INVESTIGATOR",{"name":122,"role":120,"phone":50,"phoneExt":50,"email":50},"Seung C Kim, MD,FFPMRCA",{"name":124,"role":120,"phone":50,"phoneExt":50,"email":50},"Faraj W Abdallah, MD,FRCPC",{"name":126,"role":120,"phone":50,"phoneExt":50,"email":50},"Sam Park, MD,MASc",{"type":128,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100584244",false,"NCT06886815","Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery","The Effects of Popliteal Nerve Block on Pain and Nerve-Related Symptoms After Acute Achilles Tendon Rupture Repair Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 - 65\n* ASA classification: I - III\n* BMI \\\u003C 35 kg\u002Fm2\n* Undergoing acute Achilles tendon rupture repair surgery as a day surgery procedure\n\nExclusion Criteria:\n\n* Pre-existing neurological deficits or peripheral neuropathy in the distribution of the tibial or common peroneal nerves\n* Local infection\n* Contraindication to regional anesthesia (e.g., bleeding diathesis, coagulopathy)\n* History of use of over 30 mg oxycodone or equivalent per day\n* Contraindication to any component of a standard multi-modal analgesia\n* Allergy to local anesthetics\n* History of significant psychiatric conditions that may affect patient assessment\n* Pregnancy\n* Inability to provide informed consent\n* Patient refusal of popliteal nerve blockade\n* Prior Achilles tendon surgeries on the operative leg\n* Unable to speak or read English","ALL","18 Years","65 Years",{"count":139,"type":140},80,"ESTIMATED","INTERVENTIONAL",[143],"NA","Achilles tendon rupture is common, yet the value of popliteal nerve block for postoperative pain control during surgical repair remains uncertain. Despite widespread use, evidence supporting its analgesic effectiveness is limited, and both popliteal nerve block and Achilles tendon repair carry risks of nerve injury. This randomized, placebo-controlled trial will evaluate whether adding a popliteal nerve block to standard systemic analgesia improves postoperative pain and reduces opioid use in patients undergoing acute Achilles tendon rupture repair. Secondary outcomes will examine the incidence and impact of nerve complications on recovery, including return to physical activity and functional performance.",[146],"Acute Achilles Tendon Rupture",[80,148,149],"Lower Extremity Regional Anesthesia","Achilles Tendon","2026-04-21",{"date":152,"type":153},"2026-04-23","ACTUAL",{"date":155,"type":153},"2026-03-17",{"date":157,"type":140},"2028-03",{"name":5,"class":6},1]