[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591555":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":38,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":26,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":26,"overallStatus":64,"whyStopped":26,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":26},{"fullName":5,"class":6},"Lebanese American University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group Ropivacaine Only (R)","ACTIVE_COMPARATOR","In Group R, patients will receive 20 ml of 0.375% ropivacaine in each side of a bilateral single-shot ultrasound-guided erector spinae plane block.",[13],"Drug: Ropivacaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Group Combination Ropivacaine and Dexmedetomidine (RD)","EXPERIMENTAL","In Group RD, patients will receive 20 ml of 0.375% ropivacaine plus 0.5 micrograms\u002Fkg of dexmedetomidine in each side of a bilateral single-shot ultrasound-guided erector spinae plane block.",[19],"Drug: Dexmedetomidine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","Dexmedetomidine added to ropivacaine in the bilateral single-shot Ultrasound-guided erector spinae plane block that will be applied to each side (bilateral):\n\n20ml\u002Fside of 0.375% ropivacaine+0.5 μg\u002Fkg\u002Fside of dexmedetomidine (lean body weight if BMI \\>30)",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ropivacaine","Ropivacaine only in the Bilateral single-shot Ultrasound-guided Erector Spinae Plane Block:\n\n20ml\u002Fside of 0.375% ropivacaine",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Caroline Chahine, MD","CONTACT","+ 961 1 200800","5168","caroline.chahine@lau.edu.lb",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":42,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Caroline Chahine","Clinical Instructor of Medicine","Lebanese American University Medical Center","100591555","phase-4-addition-of-dexmedetomidine-to-ropivacaine-in-bilateral-erector-spinae-plane-block-in-patients-undergoing-coronary-artery-bypass-surgery-100591555",false,"NCT06981949","Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery","The Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery - A Double-blinded Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age range: 25 - 80 years old\n2. Planned for elective OFF PUMP CABG\n3. Cognitively not impaired\n4. American Society of Anesthesiologists class 3\n5. Left ventricular ejection fraction ≥40%\n6. Consent form for the study signed\n7. No infection at the site of injection\n8. No contraindication for ESP block (thrombocytopenia, anticoagulation therapy)\n9. No documented allergy to ropivacaine or dexmedetomidine\n\nExclusion Criteria:\n\n1. Refusal to participate in the study\n2. Emergency surgery\n3. American Society of Anesthesiologists class \\>3\n4. Left ventricular ejection fraction \\\u003C40%\n5. Infection at the site of injection for ultrasound-guided ESPB\n6. Coagulation disorders\n7. Documented allergy to ropivacaine or dexmedetomidine\n8. Greater than first-degree heart block\n9. Bradycardia (heart rate \\[HR\\] \\\u003C 50 bpm)\n10. Pregnancy\n11. BMI ≥40\n12. Psychiatric illnesses that would interfere with the assessment of pain scores\n13. History of alcohol or drug abuse and chronic analgesic use","ALL","25 Years","80 Years",{"count":54,"type":55},110,"ESTIMATED","INTERVENTIONAL",[58],"PHASE4","Coronary artery bypass surgery (CABG), typically performed through a median sternotomy, causes significant postoperative pain. Managing this pain effectively while reducing reliance on opioids is essential, as opioids can lead to side effects such as respiratory depression, nausea, and potential for dependence. Regional anesthesia techniques like the erector spinae plane block (ESPB) have emerged as promising tools to control pain and support recovery.\n\nThis randomized, double-blind clinical trial evaluates whether adding dexmedetomidine, a sedative and analgesic, to ropivacaine, a local anesthetic, in bilateral ESPB can improve pain control after off-pump CABG surgery. The study is conducted at the Lebanese American University Medical Center - Rizk Hospital.\n\nA total of 110 adult patients undergoing elective surgery are randomly assigned to one of two groups:\n\n1. Group R: Receives ropivacaine alone in the ESPB.\n2. Group RD: Receives ropivacaine with dexmedetomidine.\n\nThe nerve block is administered before anesthesia. The primary outcome is the duration of effective pain relief (pain score ≤4) before the patient needs opioid medication, assessed up to 24 hours after extubation.\n\nSecondary outcomes include:\n\n1. Pain scores monitored for up to 48 hours post-extubation\n2. Total intraoperative opioid use\n3. Time to extubation, ambulation, and incentive spirometry use\n4. ICU stay duration\n5. Side effects such as nausea, bradycardia, or local anesthetic toxicity\n\nThis study supports efforts to reduce opioid use after heart surgery while maintaining effective pain management, aligning with enhanced recovery protocols and addressing the broader public health challenge of opioid overuse.",[61,62,63],"Pain","Pain Management Following Cardiopulmonary Bypass Surgery","Erector Spinae Plane Block","NOT_YET_RECRUITING","2025-05-17",{"date":67,"type":68},"2025-05-21","ACTUAL",{"date":70,"type":55},"2025-05-15",{"date":72,"type":55},"2026-05-16",{"name":5,"class":6}]