[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656512":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":34,"interventions":51,"overallOfficials":25,"centralContacts":64,"locations":74,"responsibleParty":91,"collaborators":25,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":25,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":25,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":25,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Atatürk Chest Diseases and Chest Surgery Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Morphine Consumption via Patient-Controlled Analgesia","The total amount of intravenous morphine administered via patient-controlled analgesia during the first 24 postoperative hours will be recorded in milligrams (mg) based on the PCA device records.","Up to 24 hours after surgery",[14,17,19,22],{"measure":15,"description":16,"timeFrame":12},"Pain scores","Pain will be assessed at rest using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 4th, 8th, 12th, and 24th hours after surgery.",{"measure":15,"description":18,"timeFrame":12},"Pain will be assessed while coughing using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 4th, 8th, 12th, and 24th hours after surgery.",{"measure":20,"description":21,"timeFrame":12},"Total Rescue Tramadol Consumption","The total amount of intravenous tramadol administered as rescue analgesia during the first 24 postoperative hours will be recorded in milligrams (mg). Intravenous tramadol will be administered when the Visual Analog Scale (VAS) pain score is greater than 40 mm.",{"measure":23,"description":24,"timeFrame":12},"Side effects","Side effects, such as allergy , hypotension, nausea\u002Fvomiting, and itching, will be recorded.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":32},"SINGLE",[33],"OUTCOMES_ASSESSOR",[35,41,46],{"label":36,"type":37,"description":38,"interventionNames":39},"Intrathecal Morphine","ACTIVE_COMPARATOR","Participants will receive spinal anesthesia with 12.5 mg of 0.5% hyperbaric bupivacaine combined with 0.1 mg (100 mcg) of intrathecal morphine, with a total intrathecal volume of 3 mL. No additional peripheral nerve block will be performed. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.",[40],"Procedure: Intrathecal Morphine Group",{"label":42,"type":37,"description":43,"interventionNames":44},"Transversalis Fascia Plane Block","Participants will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine (3 mL). At the end of surgery, an ultrasound-guided unilateral transversalis fascia plane block will be performed on the surgical side using 30 mL of 0.25% bupivacaine. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.",[45],"Procedure: Transversalis Fascia Plane Block Group",{"label":47,"type":37,"description":48,"interventionNames":49},"Spinal Anesthesia Alone","Participants will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine (3 mL) administered intrathecally. No additional neuraxial opioid or regional block will be performed. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.",[50],"Procedure: Control Group",[52,57,61],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":25},"PROCEDURE","Intrathecal Morphine Group","Spinal anesthesia will be performed using 12.5 mg of 0.5% hyperbaric bupivacaine combined with 0.1 mg (100 mcg) of intrathecal morphine, prepared to a total intrathecal volume of 3 mL. No additional peripheral regional block will be performed in this group. Participants will subsequently receive the standardized postoperative multimodal analgesia and intravenous patient-controlled analgesia protocol.",[36],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":25},"Transversalis Fascia Plane Block Group","Spinal anesthesia will be performed with 15 mg of 0.5% hyperbaric bupivacaine (3 mL). At the completion of surgery, an ultrasound-guided unilateral transversalis fascia plane block will be performed on the surgical side. A 22-gauge, 80-100 mm block needle will be advanced using an in-plane technique to the transversalis fascial plane, and 30 mL of 0.25% bupivacaine will be injected after negative aspiration. Participants will subsequently receive the standardized postoperative multimodal analgesia and intravenous patient-controlled analgesia protocol.",[42],{"type":53,"name":62,"description":55,"armGroupLabels":63,"otherNames":25},"Control Group",[47],[65,70],{"name":66,"role":67,"phone":68,"phoneExt":25,"email":69},"Musa Zengin, Associate Professor","CONTACT","00905307716235","musazengin@gmail.com",{"name":71,"role":67,"phone":72,"phoneExt":25,"email":73},"Şule Küreşci Karagöz, Medical Doctor","00905526825835","suleekuresci@gmail.com",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":25,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Ankara Etlik City Hospital","RECRUITING","Yenimahalle","Ankara","06170","Turkey (Türkiye)",{"type":83,"coordinates":84},"Point",[85,86],32.80147,39.97787,{"lat":86,"lon":85},[89,90],{"name":66,"role":67,"phone":68,"phoneExt":25,"email":69},{"name":71,"role":67,"phone":72,"phoneExt":25,"email":73},{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":76,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Musa Zengin","Principal Investigator","100656512","intrathecal-morphine-and-transversalis-fascia-plane-block-for-analgesia-after-open-inguinal-hernia-repair-100656512",false,"NCT07826741","Intrathecal Morphine and Transversalis Fascia Plane Block for Analgesia After Open Inguinal Hernia Repair","Comparison of Intrathecal Morphine, Transversalis Fascia Plane Block, and Spinal Anesthesia Alone for Postoperative Analgesia in Open Inguinal Hernia Repair: A Prospective, Randomized, Assessor-Blinded, Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 80 years\n* American Society of Anesthesiologists physical status I-II-III\n* Body mass index between 18 and 30 kg\u002Fm²\n* Patients undergoing elective open inguinal hernia repair\n\nExclusion Criteria:\n\n* Patient refusing the procedure\n* History of chronic analgesic or opioid therapy\n* History of local anesthetic and morphine allergy\n* Infection in the intervention area","ALL","18 Years","80 Years",{"count":106,"type":107},90,"ESTIMATED","INTERVENTIONAL",[110],"NA","Inguinal hernia is a common surgical condition, and open inguinal hernia repair may be associated with significant postoperative pain. Inadequate pain control can delay early mobilization, reduce patient comfort, and increase the need for opioid analgesics. Therefore, effective postoperative pain management is an important component of perioperative care.\n\nSeveral analgesic strategies can be used after open inguinal hernia repair, including systemic multimodal analgesia, neuraxial opioids, and regional anesthesia techniques. Intrathecal morphine can provide prolonged postoperative analgesia but may be associated with opioid-related adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. Ultrasound-guided transversalis fascia plane block is a regional anesthesia technique designed to provide analgesia to the inguinal region while potentially reducing systemic opioid requirements.\n\nThe aim of this prospective, randomized, assessor-blinded, controlled trial is to compare the postoperative analgesic efficacy of intrathecal morphine, transversalis fascia plane block, and spinal anesthesia alone in adult patients undergoing elective open unilateral inguinal hernia repair.",[113,114,36,42,115],"Pain, Postoperative","Inguinal Hernia Unilateral","Multimodal Analgesia","2026-09-18",{"date":118,"type":119},"2026-09-21","ACTUAL",{"date":116,"type":119},{"date":122,"type":107},"2027-04-25",{"name":5,"class":6},1]