[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597938":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":52,"studyPopulation":38,"armGroups":53,"interventions":71,"overallOfficials":85,"centralContacts":90,"locations":100,"responsibleParty":112,"collaborators":38,"id":116,"slug":38,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":38,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":141,"whyStopped":38,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Yuzuncu Yil University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative pain intensity - Area Under the Curve (VAS AUC 0-24 hours)","Pain intensity is assessed using a 0-10 Visual Analog Scale (VAS) at 0, 2, 6, 12, and 24 hours postoperatively. The primary outcome is the area under the curve (AUC) calculated from these five time points using the trapezoidal rule. AUC represents the total pain burden over the first 24 hours.","0, 2, 6, 12, 24 hours postoperatively",[14,18,22,25,28,31,34],{"measure":15,"description":16,"timeFrame":17},"Time to first analgesic requirement","Time from the end of surgery to the first rescue analgesic administration will be recorded in minutes.","Within 24 hours postoperatively",{"measure":19,"description":20,"timeFrame":21},"Total analgesic consumption","Total rescue analgesic (deksketoprofen) consumption during the first 24 hours after surgery will be recorded in milligrams.","24 hours postoperatively",{"measure":23,"description":24,"timeFrame":21},"Postoperative nausea severity (0-3 scale)","Nausea severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.",{"measure":26,"description":27,"timeFrame":21},"Number of vomiting episodes","The number of postoperative vomiting episodes will be recorded within the first 24 hours after surgery.",{"measure":29,"description":30,"timeFrame":21},"Postoperative itching severity (0-3 scale)","Itching severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.",{"measure":32,"description":33,"timeFrame":21},"Postoperative shivering severity (0-3 scale)","Shivering severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.",{"measure":35,"description":36,"timeFrame":37},"Adverse events","Adverse events will be recorded as follows: nausea, vomiting, itching, and shivering within the first 24 hours postoperatively; and joint infection within 30 days postoperatively.","Up to 30 days postoperatively",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial.","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":47},"QUADRUPLE","All study solutions will be prepared by an independent investigator and administered in identical syringes. Patients, surgeons, anesthesiologists, and outcome assessors will be blinded to group allocation.",[48,49,50,51],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Postoperative pain remains a significant concern following knee arthroscopy, even in minimally invasive procedures. Various intraarticular agents have been investigated to improve postoperative analgesia, reduce opioid consumption, and enhance patient comfort. Tramadol, a centrally acting analgesic with additional peripheral effects, has been shown to provide analgesia when administered intraarticularly. Dexamethasone, a corticosteroid with anti-inflammatory properties, may enhance analgesic efficacy when used as an adjuvant.\n\nThis study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the postoperative analgesic effects of intraarticular tramadol and tramadol combined with dexamethasone in patients undergoing elective knee arthroscopy.\n\nA total of 120-135 patients aged 18-65 years with ASA physical status I-II scheduled for knee arthroscopy under general anesthesia will be included. Patients will be randomly assigned into three groups in a 1:1:1 ratio using a computer-generated block randomization method.\n\nAt the end of the surgical procedure, after aspiration of the irrigation fluid and before closure of the portal, the study solutions will be administered intraarticularly in a standardized volume of 20 mL. The groups will be as follows: placebo (normal saline), tramadol (100 mg), and tramadol (100 mg) combined with dexamethasone (8 mg). All study solutions will be prepared by an independent investigator in identical syringes to ensure blinding of patients, surgeons, anesthesiologists, and outcome assessors.\n\nAll patients will receive standardized general anesthesia and postoperative analgesia protocols. VAS at 0 hour is measured only when Ramsay Sedation Score ≤3. Total irrigation volume (L) is recorded.Intraoperative analgesia is standardized: fentanyl 1 mcg\u002Fkg at induction, additional 0.5 mcg\u002Fkg as needed (max 3 mcg\u002Fkg total). All patients receive IV paracetamol 15 mg\u002Fkg before extubation. Total intraoperative fentanyl dose is recorded.\n\nThe primary outcome is the area under the curve (AUC) of VAS scores measured at 0, 2, 6, 12, and 24 hours postoperatively (VAS AUC 0-24h). Rescue analgesia will be administered as IV dexketoprofen 50 mg if VAS ≥4. Pain will be reassessed after 30 minutes; if VAS remains ≥4, a second dose may be administered. The minimum interval between doses will be 30 minutes, with a maximum total dose of 150 mg within 24 hours. Total dexketoprofen consumption will be recorded. Secondary outcomes include time to first analgesic requirement, total analgesic consumption within 24 hours, and the incidence and severity of adverse effects such as nausea, vomiting, itching, shivering, and potential complications.\n\nThis study aims to determine whether intraarticular tramadol provides effective postoperative analgesia and whether the addition of dexamethasone enhances this effect, thereby contributing to improved postoperative pain management strategies in knee arthroscopy. To ensure procedural homogeneity, only minor arthroscopic procedures such as partial meniscectomy will be included, while major reconstructive procedures (e.g., anterior cruciate ligament reconstruction) will be excluded.",[54,60,66],{"label":55,"type":56,"description":57,"interventionNames":58},"Placebo Group","PLACEBO_COMPARATOR","Patients will receive 20 mL of normal saline administered intraarticularly at the end of surgery.",[59],"Drug: Saline",{"label":61,"type":62,"description":63,"interventionNames":64},"Tramadol Group","EXPERIMENTAL","Patients will receive 100 mg tramadol diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.",[65],"Drug: Tramadol",{"label":67,"type":62,"description":68,"interventionNames":69},"Tramadol + Dexamethasone Group","Patients will receive 100 mg tramadol combined with 8 mg dexamethasone diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.",[70],"Drug: Tramadol + Dexamethasone",[72,77,81],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":38},"DRUG","Saline","20 mL of normal saline administered intraarticularly at the end of surgery.",[55],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":38},"Tramadol","Tramadol 100 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.",[61],{"type":73,"name":82,"description":83,"armGroupLabels":84,"otherNames":38},"Tramadol + Dexamethasone","Tramadol 100 mg combined with dexamethasone 8 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.",[67],[86],{"name":87,"affiliation":88,"role":89},"Şükran Sevimli, PhD","Van Yuzuncu Yil University Ethics","STUDY_CHAIR",[91,96],{"name":92,"role":93,"phone":94,"phoneExt":38,"email":95},"Arzu Esen Tekeli, MD","CONTACT","+905053756375","esentekeli190807@hotmail.com",{"name":97,"role":93,"phone":98,"phoneExt":38,"email":99},"Doğukan Çatulay, MD","05556880881","dctly9292@gmail.com",[101],{"facility":102,"status":38,"city":103,"state":38,"zip":104,"country":105,"countryCode":38,"cosmosGeoPoint":106,"geoPoint":111,"contacts":38},"Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation","Van","65100","Turkey (Türkiye)",{"type":107,"coordinates":108},"Point",[109,110],43.38323,38.49457,{"lat":110,"lon":109},{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Arzu Esen Tekeli","Associate Professor of Anesthesiology","100597938",false,"NCT07064993","Effects of Intraarticular Tramadol and Tramadol-Dexamethasone on Postoperative Pain After Knee Arthroscopy","A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Effects of Intraarticular Tramadol and Tramadol Plus Dexamethasone on Postoperative Pain After Knee Arthroscopy","KATD-PAIN","Inclusion Criteria:\n\nPatients aged 18-65 years ASA physical status I-II Scheduled for elective knee arthroscopy under general anesthesia Only minor arthroscopic procedures such as partial meniscectomy will be included Ability to provide informed consent\n\nExclusion Criteria:\n\nAllergy or contraindication to tramadol or dexamethasone Chronic opioid use or chronic pain conditions History of psychiatric or neurological disorders that may affect pain perception Severe hepatic or renal impairment Pregnancy or breastfeeding Infection at the injection site Bleeding diathesis Refusal to participate Major reconstructive knee surgeries (e.g., anterior cruciate ligament reconstruction)","ALL","18 Years","65 Years",{"count":127,"type":128},135,"ESTIMATED","INTERVENTIONAL",[131],"PHASE4","Patients scheduled for elective knee arthroscopy under general anesthesia will be randomly assigned into three groups in a 1:1:1 ratio: placebo (saline), tramadol, and tramadol plus dexamethasone. At the end of surgery, after aspiration of the irrigation fluid, the study solution will be administered intraarticularly in a standardized volume.\n\nThe primary outcome is the area under the curve (AUC) of VAS scores measured at 0, 2, 6, 12, and 24 hours postoperatively (VAS AUC 0-24h). Secondary outcomes include time to first analgesic requirement, total analgesic consumption within 24 hours, and the incidence of adverse effects such as nausea, vomiting, itching, and shivering.\n\nThis study aims to determine whether intraarticular tramadol provides effective postoperative analgesia and whether the addition of dexamethasone enhances this analgesic effect.",[134,135],"Knee Arthroscopy","Postoperative Pain",[134,135,137,78,138,139,140],"Intraarticular Injection","Dexamethasone","Analgesia","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-05-11",{"date":144,"type":145},"2026-05-14","ACTUAL",{"date":147,"type":128},"2026-07-15",{"date":149,"type":128},"2027-04-30",{"name":114,"class":6},1]