[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654094":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":50,"studyPopulation":37,"armGroups":51,"interventions":66,"overallOfficials":85,"centralContacts":89,"locations":37,"responsibleParty":98,"collaborators":37,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":37,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":137,"whyStopped":37,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":37},{"fullName":5,"class":6},"Gaziantep City Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Time to first rescue analgesic request","The primary outcome is the time from completion of the superior trunk block to the first request for systemic rescue analgesia in the postoperative period. Rescue analgesia will be defined as intravenous tramadol administration when the Numeric Rating Scale pain score is greater than 3 at rest or during passive movement, or when the patient requests additional analgesia.","First rescue analgesic request, assessed up to 72 hours postoperatively. T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour",[14,18,21,25,29,33],{"measure":15,"description":16,"timeFrame":17},"Postoperative pain scores","Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale at rest and during passive movement. Higher scores indicate greater pain intensity.","T1: Postoperative 4th hour T2: Postoperative 8th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour",{"measure":19,"description":20,"timeFrame":17},"Incidence of rebound pain","Rebound pain will be defined as a sudden increase in pain intensity to a Numeric Rating Scale score greater than 7 after resolution of the nerve block.",{"measure":22,"description":23,"timeFrame":24},"Cumulative opioid consumption","Cumulative opioid consumption during the first 24 postoperative hours will be calculated and recorded as oral morphine equivalent dose in milligrams.","During the first 24 hours postoperatively.",{"measure":26,"description":27,"timeFrame":28},"Blood glucose levels","Blood glucose levels will be measured to evaluate the systemic metabolic effect of intravenous dexamethasone.","T1: postoperative 1st hour T2: postoperative 4th hour.",{"measure":30,"description":31,"timeFrame":32},"Hemodynamic events requiring treatment","The incidence of bradycardia and hypotension requiring pharmacologic treatment will be recorded. Bradycardia and hypotension will be treated according to the study protocol.","T0: Perioperative 15th minute T1: Perioperative 60th minute T2: Postoperative 4th hour T3: Postoperative 12th hour T4: Postoperative 48th hour T5: Postoperative 72th hour",{"measure":34,"description":35,"timeFrame":36},"Patient satisfaction","Patient satisfaction with the anesthesia and block technique will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.","At postoperative 72 hours.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of two parallel groups. All participants will receive ultrasound-guided superior trunk block and standard intravenous dexmedetomidine. The intervention group will receive intravenous dexamethasone 0.15 mg\u002Fkg, while the control group will receive an equal volume of 0.9% normal saline placebo.","TREATMENT",{"masking":44,"maskingDescription":45,"whoMasked":46},"TRIPLE","This is a triple-blind trial. The study drug or placebo will be prepared by an independent staff member who will not participate in block performance, intraoperative care, postoperative data collection, or statistical analysis. Participants, the anesthesiologist performing the block and administering the study syringe, and the postoperative outcome assessor will be blinded to group allocation. Statistical analysis will be performed using coded groups.",[47,48,49],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","Effective postoperative analgesia after arthroscopic shoulder surgery is important for patient comfort, early mobilization, and reduction of postoperative complications. Interscalene brachial plexus block is widely used for shoulder surgery; however, it may be associated with hemidiaphragmatic paresis and respiratory complications. Superior trunk block has been proposed as an alternative regional anesthesia technique that may provide effective analgesia with a potentially lower risk of respiratory impairment.\n\nAdjuvant agents are frequently used to prolong the duration and improve the quality of analgesia after peripheral nerve blocks. Intravenous dexamethasone has been shown to prolong analgesia and improve postoperative pain control. Dexmedetomidine is another adjuvant agent with sedative and analgesic properties. However, evidence regarding the combined use of intravenous dexamethasone and intravenous dexmedetomidine in patients receiving superior trunk block for arthroscopic shoulder surgery is limited.\n\nThis study is designed as a prospective, randomized, placebo-controlled, triple-blind clinical trial. Adult patients aged 18 to 65 years, classified as American Society of Anesthesiologists physical status I to III, scheduled for elective arthroscopic shoulder surgery, and eligible for superior trunk block will be included after written informed consent.\n\nAll patients will receive standard monitoring before block placement. Premedication with intravenous midazolam may be administered for anxiolysis. A superficial cervical plexus block will be performed with 3 mL of 0.5% bupivacaine, followed by ultrasound-guided superior trunk block using 15 mL of 0.5% bupivacaine. Block success will be assessed approximately 20 minutes after block completion using sensory and motor evaluation.\n\nParticipants will be randomly assigned to one of two groups using a computer-generated randomization sequence and sealed opaque envelopes. In the intervention group, patients will receive standard intravenous dexmedetomidine infusion plus intravenous dexamethasone 0.15 mg\u002Fkg. In the control group, patients will receive standard intravenous dexmedetomidine infusion plus an equal volume of 0.9% normal saline placebo. The study drug or placebo will be prepared by an independent staff member who will not be involved in block performance, data collection, or outcome assessment. The patient, block practitioner, postoperative outcome assessor, and statistician will remain blinded to group allocation.\n\nAll patients will receive a standardized postoperative multimodal analgesia protocol. Intravenous ibuprofen 400 mg will be administered every 8 hours. Intravenous tramadol 50 mg will be used as rescue analgesia when the Numeric Rating Scale pain score is greater than 3 at rest or during passive movement, or when the patient requests additional analgesia. At least 4 hours will be allowed between tramadol doses, and the maximum daily tramadol dose will be limited to 400 mg.\n\nThe primary outcome is the time from completion of the superior trunk block to the first request for systemic rescue analgesia in the postoperative period. Secondary outcomes include sensory and motor block characteristics, postoperative Numeric Rating Scale pain scores at 4, 8, 12, 24, and 72 hours, incidence of rebound pain, cumulative opioid consumption during the first 24 hours, perioperative blood glucose levels, hemodynamic events requiring treatment, postoperative nausea and vomiting, sleep disturbance due to pain during the first two nights, transient block-related complications such as Horner syndrome, hoarseness or dyspnea, and patient satisfaction at postoperative 72 hours.",[52,60],{"label":53,"type":54,"description":55,"interventionNames":56},"Dexamethasone Group","EXPERIMENTAL","Participants in this arm will receive ultrasound-guided superior trunk block with 15 mL of 0.5% bupivacaine and standard intravenous dexmedetomidine 0.5 mcg\u002Fkg as a 30-minute infusion. In addition, intravenous dexamethasone 0.15 mg\u002Fkg will be administered before surgery.",[57,58,59],"Drug: Intravenous Dexamethasone","Drug: Intravenous Dexmedetomidine","Procedure: Superior Trunk Block",{"label":61,"type":62,"description":63,"interventionNames":64},"Placebo Group","PLACEBO_COMPARATOR","Participants in this arm will receive ultrasound-guided superior trunk block with 15 mL of 0.5% bupivacaine and standard intravenous dexmedetomidine 0.5 mcg\u002Fkg as a 30-minute infusion. In addition, an equal volume of 0.9% normal saline placebo will be administered before surgery.",[65,58,59],"Drug: Normal Saline Placebo",[67,72,76,80],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":37},"DRUG","Intravenous Dexamethasone","Intravenous dexamethasone 0.15 mg\u002Fkg will be administered before surgery to participants assigned to the dexamethasone group, in addition to ultrasound-guided superior trunk block and standard intravenous dexmedetomidine infusion.",[53],{"type":68,"name":73,"description":74,"armGroupLabels":75,"otherNames":37},"Normal Saline Placebo","An equal volume of 0.9% normal saline placebo will be administered before surgery to participants assigned to the placebo group, in addition to ultrasound-guided superior trunk block and standard intravenous dexmedetomidine infusion.",[61],{"type":68,"name":77,"description":78,"armGroupLabels":79,"otherNames":37},"Intravenous Dexmedetomidine","Intravenous dexmedetomidine 0.5 mcg\u002Fkg will be administered as a 30-minute infusion to all participants in both study groups.",[53,61],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":37},"PROCEDURE","Superior Trunk Block","Ultrasound-guided superior trunk block will be performed in all participants using 15 mL of 0.5% bupivacaine before arthroscopic shoulder surgery. Block success will be assessed approximately 20 minutes after block completion.",[53,61],[86],{"name":87,"affiliation":5,"role":88},"Bekir Suat Kürkçüoğlu, MD","PRINCIPAL_INVESTIGATOR",[90,94],{"name":87,"role":91,"phone":92,"phoneExt":37,"email":93},"CONTACT","+90 505 583 04 63","bekirsuat@gmail.com",{"name":95,"role":91,"phone":96,"phoneExt":37,"email":97},"Sinan Ünsal, MD","+90 5380537502","sinannsal93@gmail.com",{"type":99,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100654094","phase-4-intravenous-dexamethasone-added-to-dexmedetomidine-after-superior-trunk-block-100654094",false,"NCT07795281","Intravenous Dexamethasone Added to Dexmedetomidine After Superior Trunk Block","Effect of Intravenous Dexamethasone Added to Intravenous Dexmedetomidine on Postoperative Analgesia After Superior Trunk Block for Arthroscopic Shoulder Surgery: A Prospective, Randomized, Placebo-Controlled, Triple-Blind Trial","STB-DEX","Inclusion Criteria: Patients aged 18 to 65 years. Patients classified as American Society of Anesthesiologists physical status I to III.\n\nPatients scheduled for elective arthroscopic shoulder surgery. Patients with a body mass index between 18.5 and 35 kg\u002Fm². Patients who are able to understand the study protocol and provide written informed consent.\n\n\\-\n\nExclusion Criteria: Patients younger than 18 years or older than 65 years. Patients classified as American Society of Anesthesiologists physical status IV or higher.\n\nContraindications to peripheral nerve block, including coagulopathy or infection at the block site.\n\nKnown allergy or contraindication to any of the drugs used in the study. Active gastrointestinal bleeding, history of peptic ulcer disease, or severe renal or hepatic insufficiency.\n\nHistory of chronic analgesic or opioid use. Pregnancy or breastfeeding. Presence of coagulopathy or use of anticoagulant or antiplatelet therapy. Requirement for additional sedation or general anesthesia during surgery. Neurological or psychiatric disease that may affect pain assessment.\n\n\\-","ALL","18 Years","65 Years",{"count":112,"type":113},70,"ESTIMATED","INTERVENTIONAL",[116],"PHASE4","This prospective, randomized, placebo-controlled, triple-blind trial will evaluate the effect of adding intravenous dexamethasone to intravenous dexmedetomidine on postoperative analgesia after superior trunk block in adult patients undergoing elective arthroscopic shoulder surgery.\n\nAll participants will receive ultrasound-guided superior trunk block and standard intravenous dexmedetomidine. Participants will be randomly assigned to receive either intravenous dexamethasone or an equal volume of normal saline placebo before surgery. The main outcome will be the time from completion of the block to the first request for rescue analgesia after surgery.\n\nThe study will also evaluate postoperative pain scores, rebound pain, opioid consumption, blood glucose levels, hemodynamic changes, postoperative nausea and vomiting, sleep disturbance due to pain, block-related complications, and patient satisfaction.",[119,120,121],"Postoperative Pain","Arthroscopic Shoulder Surgery","Regional Anesthesia",[123,124,125,126,127,128,129,130,131,132,133,134,135,136,34],"Superior trunk block","Arthroscopic shoulder surgery","Postoperative analgesia","Intravenous dexamethasone","Intravenous dexmedetomidine","Placebo-controlled trial","Randomized controlled trial","Triple-blind trial","Rebound pain","Numeric Rating Scale","Rescue analgesia","Peripheral nerve block","Bupivacaine","Opioid consumption","NOT_YET_RECRUITING","2026-08-27",{"date":140,"type":141},"2026-08-31","ACTUAL",{"date":143,"type":113},"2026-09",{"date":145,"type":113},"2027-01",{"name":5,"class":6}]