[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625536":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":48,"studyPopulation":35,"armGroups":49,"interventions":75,"overallOfficials":107,"centralContacts":112,"locations":118,"responsibleParty":130,"collaborators":35,"id":132,"slug":35,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":35,"enrollmentInfo":141,"targetDuration":35,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":120,"whyStopped":35,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Tampere University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Total cumulative opioid consumption (intravenous morphine equivalent dose, mg)","Total cumulative opioid dose administered intraoperatively and postoperatively, converted to intravenous morphine equivalent dose (mg) using standardized equianalgesic conversion factors.","Perioperative\u002FPeriprocedural",[14,18,22,25,28,31],{"measure":15,"description":16,"timeFrame":17},"Postoperative pain intensity (Numeric Rating Scale, NRS 0-10)","Postoperative pain intensity assessed using a Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.","1 hour and 24 hours after surgery",{"measure":19,"description":20,"timeFrame":21},"Number of participants requiring rescue analgesia within 24 hours","Number of participants requiring additional rescue analgesic medication due to inadequate pain control.","Up to 24 hours",{"measure":23,"description":24,"timeFrame":21},"Number of participants with postoperative nausea and\u002For vomiting","Occurrence of postoperative nausea and\u002For vomiting and need for antiemetic medication.",{"measure":26,"description":27,"timeFrame":21},"Time to fulfillment of discharge criteria","Time from completion of surgery to fulfillment of predefined discharge criteria according to institutional day-surgery protocol",{"measure":29,"description":30,"timeFrame":21},"Number of participants with unplanned hospital admission within 24 hours","Number of participants requiring unplanned hospital admission or prolonged hospital stay following planned day-case surgery.",{"measure":32,"description":33,"timeFrame":34},"Presence of chronic postoperative pain","Presence of persistent postoperative pain assessed during follow-up using patient self-report.","1 week and 1, 3, 5, and 10 years after surgery",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"RANDOMIZED","FACTORIAL","This is a 2 × 2 factorial randomized study evaluating the individual and combined effects of rectus sheath (RS) block and transversus abdominis plane (TAP) block. Participants are randomized into four groups receiving combined RS and TAP blocks, TAP block only, RS block only, or placebo blocks.","TREATMENT",{"masking":42,"maskingDescription":35,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study is a prospective, randomized, double-blind clinical trial evaluating the effects of ultrasound-guided transversus abdominis plane (TAP) block and rectus sheath (RS) block on postoperative recovery after open inguinal hernia surgery. The study uses a 2 × 2 factorial design, with participants randomized into four groups receiving combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks, in addition to standard perioperative care.\n\nThe primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalent dose. Secondary outcomes include postoperative pain intensity, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, and unplanned hospital admission.",[50,60,66,70],{"label":51,"type":52,"description":53,"interventionNames":54},"Combined TAP + RS block","EXPERIMENTAL","Participants receive active TAP block and active RS block in addition to standard perioperative care.",[55,56,57,58,59],"Procedure: Transversus abdominis plane block (TAP block)","Procedure: Rectus sheath block (active)","Drug: Ropivacaine","Device: Ultrasound device","Drug: Morphine",{"label":61,"type":52,"description":62,"interventionNames":63},"TAP block only","Participants receive active TAP block and placebo RS block in addition to standard perioperative care.",[55,64,57,65,58,59],"Procedure: Placebo nerve block","Drug: Sodium chloride",{"label":67,"type":52,"description":68,"interventionNames":69},"RS block only","Participants receive active RS block and placebo TAP block in addition to standard perioperative care.",[56,64,57,65,58,59],{"label":71,"type":72,"description":73,"interventionNames":74},"Placebo TAP + Placebo RS","PLACEBO_COMPARATOR","Participants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care.",[64,65,58,59],[76,81,85,89,94,98,103],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":35},"PROCEDURE","Transversus abdominis plane block (TAP block)","Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia.",[51,61],{"type":77,"name":82,"description":83,"armGroupLabels":84,"otherNames":35},"Rectus sheath block (active)","Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia.",[51,67],{"type":77,"name":86,"description":87,"armGroupLabels":88,"otherNames":35},"Placebo nerve block","Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.",[71,67,61],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":35},"DRUG","Ropivacaine","Ropivacaine 7.5 mg\u002Fml diluted 1:1 with saline, used for active transversus abdominis plane (TAP) and\u002For rectus sheath (RS) blocks administered preoperatively for postoperative analgesia.",[51,67,61],{"type":90,"name":95,"description":96,"armGroupLabels":97,"otherNames":35},"Sodium chloride","0.9% sodium chloride solution used as placebo in sham transversus abdominis plane (TAP) and rectus sheath (RS) blocks to maintain blinding.",[71,67,61],{"type":99,"name":100,"description":101,"armGroupLabels":102,"otherNames":35},"DEVICE","Ultrasound device","Ultrasound guidance used to perform transversus abdominis plane (TAP) and rectus sheath (RS) blocks.",[51,71,67,61],{"type":90,"name":104,"description":105,"armGroupLabels":106,"otherNames":35},"Morphine","Standard perioperative opioid analgesics administered intraoperatively and postoperatively according to institutional protocol. Opioid doses are recorded and converted to intravenous morphine equivalent dose for outcome assessment.",[51,71,67,61],[108],{"name":109,"affiliation":110,"role":111},"Aki Lumme","Tampere University Hospital, Pirkanmaa Wellbeing Services County","PRINCIPAL_INVESTIGATOR",[113],{"name":114,"role":115,"phone":116,"phoneExt":35,"email":117},"Aki Lumme, MD","CONTACT","+358331167232","aki.lumme@pirha.fi",[119],{"facility":5,"status":120,"city":121,"state":35,"zip":35,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":35},"RECRUITING","Tampere","Finland","FI",{"type":125,"coordinates":126},"Point",[127,128],23.78712,61.49911,{"lat":128,"lon":127},{"type":131,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100625536",false,"NCT07423910","PRO-RSTAP: Effect of TAP and RS Blocks on Recovery After Inguinal Hernia Surgery (PRO-RSTAP)","Effect of Medial Transversus Abdominis Plane (TAP) Block and Rectus Sheath (RS) Block on Inguinal Hernia Surgery Recovery, a Prospective Randomized Double-blind Study (PRO-RSTAP)","PRO-RSTAP","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Elective unilateral open inguinal hernia repair\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Bilateral or recurrent inguinal hernia\n* Contraindication to regional anesthesia or study interventions\n* Known allergy to local anesthetics\n* Inability to comply with study procedures","ALL","18 Years",{"count":142,"type":143},200,"ESTIMATED","INTERVENTIONAL",[146],"NA","Inguinal hernia repair is a common surgical procedure, often performed as day-case surgery. Despite standardized surgical techniques, postoperative pain may delay recovery and occasionally lead to unplanned hospital admission.\n\nThe PRO-RSTAP study is a prospective, randomized, double-blind clinical trial evaluating whether ultrasound-guided transversus abdominis plane (TAP) block, rectus sheath (RS) block, or their combination improves postoperative recovery after open inguinal hernia surgery. Adult patients undergoing unilateral open inguinal hernia repair are randomized into four groups receiving either combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks , in addition to standard perioperative care.\n\nThe primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalents. Secondary outcomes include postoperative pain scores, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, unplanned hospital admission, and chronic postoperative pain during long-term follow-up.\n\nThe aim of this study is to determine the individual and combined effects of TAP and RS blocks on postoperative analgesia and recovery in patients undergoing open inguinal hernia repair.",[149],"Inguinal Hernia",[151,152,153,154,155],"Open inguinal hernia repair","Regional anesthesia","Transversus abdominis plane block","Rectus sheath block","Postoperative analgesia","2026-02-13",{"date":158,"type":159},"2026-02-20","ACTUAL",{"date":161,"type":159},"2025-07-01",{"date":163,"type":143},"2038-01",{"name":5,"class":6},1]