[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610786":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":65,"collaborators":27,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":53,"whyStopped":27,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Ataturk University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intrathecal Morphine Group","EXPERIMENTAL","Participants in this arm will receive 200 µg of preservative-free intrathecal morphine administered at the L3-L4 interspace prior to induction of general anesthesia. This intervention is intended to provide early postoperative analgesia following laparoscopic hysterectomy.",[13],"Drug: Intrathecal Morphine",{"label":15,"type":16,"description":17,"interventionNames":18},"Local Anesthesia Group","ACTIVE_COMPARATOR","Participants in this arm will receive 0.25% bupivacaine infiltration (5 mL at each trocar site) and 40 mL of 0.25% bupivacaine administered intraperitoneally at the end of surgery. The total dose of bupivacaine will not exceed 2 mg\u002Fkg. This technique aims to reduce postoperative somatic and visceral pain after laparoscopic hysterectomy.",[19,20],"Drug: Trocar-Site Bupivacaine Infiltration","Drug: Intraperitoneal Bupivacaine spray",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Intrathecal Morphine","A single dose of 200 µg preservative-free morphine will be administered intrathecally at the L3-L4 interspace prior to induction of general anesthesia. The injection is performed using a 25G spinal needle. This intervention aims to provide prolonged early postoperative analgesia in patients undergoing laparoscopic hysterectomy.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Trocar-Site Bupivacaine Infiltration","At the end of laparoscopic hysterectomy, 5 mL of 0.25% bupivacaine will be infiltrated into each trocar site. This intervention targets somatic pain originating from trocar entry points. It is administered only in the Local Anesthesia (LA) Group. The total dose of bupivacaine from all applications will remain within recommended safety limits.",[15],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Intraperitoneal Bupivacaine spray","A total of 40 mL of 0.25% bupivacaine will be instilled intraperitoneally after completion of the surgical procedure. This intervention is designed to reduce visceral and peritoneal irritation-related pain following laparoscopic hysterectomy. The combined bupivacaine dose from trocar-site infiltration and intraperitoneal instillation will not exceed 2 mg\u002Fkg.",[15],[37],{"name":38,"affiliation":39,"role":40},"Ayşenur Dostbil, Principal Investigator","Ataturk University Department of Anesthesiology and Reanimation","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Ayşenur Dostbil, Associate Professor","CONTACT","+90-533-367-66-96","adostbil@hotmail.com",{"name":48,"role":44,"phone":49,"phoneExt":27,"email":50},"Mehmet Akif Yılmaz, assistant doctor","+90-534-653-35-39","mehmetakifyilmaz025@gmail.com",[52],{"facility":5,"status":53,"city":54,"state":27,"zip":55,"country":56,"countryCode":27,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Erzurum","25000","Turkey (Türkiye)",{"type":58,"coordinates":59},"Point",[60,61],41.27694,39.90861,{"lat":61,"lon":60},[64],{"name":48,"role":44,"phone":49,"phoneExt":27,"email":50},{"type":40,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Aysenur Dostbil","Principal Investigator Ayşenur Dostbil","100610786","intrathecal-morphine-versus-trocar-site-and-intraperitoneal-bupivacaine-for-quality-of-recovery-after-laparoscopic-hysterectomy-100610786",false,"NCT07232108","Intrathecal Morphine Versus Trocar-Site and Intraperitoneal Bupivacaine for Quality of Recovery After Laparoscopic Hysterectomy","Effects of Intrathecal Morphine Compared With Trocar-Site Infiltration and Intraperitoneal Bupivacaine on Postoperative Quality of Recovery and Inflammatory Markers After Laparoscopic Hysterectomy: A Prospective, Randomized, Double-Blind Controlled Trial","ITM-LH-QoR","Inclusion Criteria:\n\n* Female patients aged 18-65 years.\n* Elective laparoscopic hysterectomy planned for benign gynecological conditions.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Coagulopathy or bleeding disorders.\n* Opioid dependence or chronic opioid use.\n* Allergy or contraindication to local anesthetics or morphine.\n* Contraindication to neuraxial (spinal) anesthesia.\n* History of chronic pain syndromes.\n* Severe renal or hepatic dysfunction.\n* Pregnancy or breastfeeding.","FEMALE","18 Years","65 Years",{"count":80,"type":81},64,"ESTIMATED","INTERVENTIONAL",[84],"NA","This study aims to compare the effects of intrathecal morphine with trocar-site infiltration and intraperitoneal bupivacaine on postoperative pain control, quality of recovery, and inflammatory response in patients undergoing elective laparoscopic hysterectomy. Laparoscopic hysterectomy is widely used for benign gynecologic conditions, but postoperative pain may result from trocar-site trauma, peritoneal irritation, and carbon dioxide insufflation. Effective postoperative analgesia can improve patient comfort, reduce opioid use, and enhance early recovery.\n\nIntrathecal morphine is known to provide potent early postoperative analgesia but may cause side effects such as nausea, vomiting, pruritus, and respiratory depression. Local anesthetic techniques, including trocar-site infiltration and intraperitoneal bupivacaine, have also been shown to reduce postoperative pain after minimally invasive gynecologic surgery.\n\nIn this prospective, randomized, double-blind study, patients will be assigned to one of two groups:\n\nIntrathecal morphine (ITM) administered before induction of anesthesia;\n\nLocal anesthesia group (LA) receiving trocar-site infiltration and intraperitoneal bupivacaine at the end of surgery.\n\nThe primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, pruritus, respiratory depression, early mobilization, bowel function recovery, and perioperative inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and systemic immune-inflammation index (SII).\n\nThe results of this trial are expected to guide clinicians in selecting optimal analgesic strategies for laparoscopic hysterectomy and to contribute to improved patient recovery and postoperative satisfaction.",[87,88,89],"Postoperative Pain Management","Laparoscopic Hysterectomy","Postoperative Recovery",[24,91,92,88,93,94,95,96,97,98],"Trocar-Site Infiltration","Intraperitoneal Bupivacaine","Quality of Recovery (QoR-15)","Postoperative Pain","Opioid Consumption","Inflammatory Markers","Neutrophil-to-Lymphocyte Ratio (NLR)","Systemic Immune-Inflammation Index (SII)","2025-12-02",{"date":101,"type":102},"2025-12-08","ACTUAL",{"date":104,"type":102},"2025-12-01",{"date":106,"type":81},"2026-06-02",{"name":5,"class":6},1]