[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610853":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":31,"studyPopulation":21,"armGroups":32,"interventions":45,"overallOfficials":21,"centralContacts":59,"locations":21,"responsibleParty":69,"collaborators":73,"id":77,"slug":21,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":21,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":21,"studyType":89,"phases":90,"briefSummary":31,"conditions":92,"keywords":95,"overallStatus":100,"whyStopped":21,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":21},{"fullName":5,"class":6},"Bursa City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"opioid consumption","Fentanyl will be prepared at a concentration of 10 µg\u002FmL, and patient-controlled analgesia (PCA) will be administered without a basal infusion, using a lock-out interval of 20 minutes and a bolus dose of 20 µg.","0, 2, 4, 8, 16 and 24 hours",[14,17],{"measure":15,"description":16,"timeFrame":12},"Postoperative pain scores (Numerical rating scale) (0-meaning \"no pain\" to 10-meaning \"worst pain imaginable\")","Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.",{"measure":18,"description":19,"timeFrame":20},"Global recovery scoring system (patient satisfaction scale)- QoR-15","Researchers will use the Turkish version of the Quality Improvement Survey\u002FQoR-15. PART A: Participants will be asked by researchers how they felt in the last 24 hours.(0 to 10, where: 0 = none of the time \\[poor\\] and 10 = all of the time \\[excellent\\]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Participants will be asked by the researchers whether they have experienced any of the following in the last 24 hours. (10 to 0, where: 10 = none of the time \\[excellent\\] and 0 = all of the time \\[poor\\]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed","The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":28},"DOUBLE",[29,30],"PARTICIPANT","OUTCOMES_ASSESSOR","Postoperative pain following open-heart surgery is primarily caused by median sternotomy, although additional contributors include costovertebral joint stress related to sternal retraction and the presence of chest wall and mediastinal drains during the postoperative period. This pain is often severe, especially in the early postoperative hours, making effective management both challenging and essential. Insufficient pain control frequently necessitates high doses of opioids, which may lead to adverse effects such as nausea, vomiting, respiratory complications, and postoperative delirium. Excessive use of anesthetic agents or opioids can also delay extubation and prolong the process of weaning from mechanical ventilation.\n\nThe modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is a regional anesthesia technique performed beneath the costal margin between the internal oblique and transversus abdominis muscles. It provides broad dermatomal coverage, extending approximately from the upper thoracic to the lower thoracic and upper lumbar segments. This study aims to evaluate the postoperative analgesic effectiveness of combining the M-TAPA block with a parasternal block in patients undergoing open-heart surgery.",[33,40],{"label":34,"type":35,"description":36,"interventionNames":37},"Group M-TAPA","ACTIVE_COMPARATOR","The M-TAPA and parasternal blocks will be administered before surgery.",[38,39],"Other: M TAPA block","Other: Parasternal blocks",{"label":41,"type":35,"description":42,"interventionNames":43},"Group Control","Preoperatively, a parasternal block and local anesthetic infiltration at the chest tube insertion sites will be administered to all patients.",[39,44],"Other: Local infiltration",[46,51,55],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":21},"OTHER","M TAPA block","In the M-TAPA group, the block will be performed preoperatively with the patient in the supine position under ultrasound guidance using a high-frequency linear probe (GE ML6-15-D Matrix Linear, Boston, USA) and an 80-mm block needle (Stimuplex Ultra®, Braun, Melsungen, Germany). After identifying the appropriate plane between the transversus abdominis muscle and the lower surface of the costal cartilage, 5 mL of saline will be injected to confirm correct placement. Subsequently, 20 mL of 0.25% bupivacaine will be injected bilaterally (a total of 40 mL for both sides).",[34],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":21},"Parasternal blocks","Before intubation, the block will be performed under aseptic conditions using a high-frequency ultrasound probe (GE ML6-15-D Matrix Linear, Boston, USA) placed immediately lateral to the sternum after identifying the second to fourth intercostal spaces. An 80-mm echogenic block needle (Stimuplex Ultra®, Braun, Melsungen, Germany) will then be advanced using an in-plane approach from the skin toward the plane between the pectoralis major and intercostal muscles. A total of 10 mL of 0.25% bupivacaine will be injected bilaterally.",[41,34],{"type":47,"name":56,"description":57,"armGroupLabels":58,"otherNames":21},"Local infiltration","Local anesthetic infiltration (10 mL of 0.25% bupivacaine) will be administered around the chest tube and mediastinal drain sites.",[41],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":21,"email":64},"Eralp Çevikkalp","CONTACT","+905054554875","eralpcevikkalp@hotmail.com",{"name":66,"role":62,"phone":67,"phoneExt":21,"email":68},"Emre ULUSOY","+905379492799","emreulusoy36@gmail.com",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","eralp çevikkalp","assoc prof",[74],{"name":75,"class":76},"Ulusoy, Emre, M.D.","INDIV","100610853",false,"NCT07232979","M-TAPA Block for Analgesia After Open-Heart Surgery","The Effectiveness of the Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) on Postoperative Analgesia and Recovery in Open-Heart Surgery: A Prospective, Double-Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18 to 85 years with ASA physical status II-III who are scheduled to undergo elective open-heart surgery will be included.\n\nExclusion Criteria:\n\nPatients who refuse to participate in the study\n\nPatients with coagulopathy\n\nPatients with a history of allergy or toxicity to local anesthetics\n\nPatients with hepatic or renal failure\n\nPatients with uncontrolled diabetes mellitus\n\nPatients with uncontrolled hypertension\n\nMentally disabled patients\n\nPatients receiving chronic pain therapy (opioid use)\n\nPatients using antidepressant medications\n\nPatients with neuropathic pain\n\nPatients with infection at the injection site\n\nPregnant, suspected pregnant, or breastfeeding women","ALL","18 Years","85 Years",{"count":87,"type":88},80,"ESTIMATED","INTERVENTIONAL",[91],"NA",[93,94],"Postoperative Pain","Acute Pain",[96,97,98,99],"M-TAPA block","Open-heart surgery","parasternal block","postoperative analgesia","NOT_YET_RECRUITING","2025-11-17",{"date":103,"type":104},"2025-11-19","ACTUAL",{"date":106,"type":88},"2026-01-15",{"date":108,"type":88},"2026-04-15",{"name":5,"class":6}]