[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649711":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":85,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Dharmais National Cancer Center Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined PECS II and PIP Block Group","EXPERIMENTAL","Participants receive an ultrasound-guided combination of PECS II block and superficial Parasternal Intercostal Plane (PIP) block following general anesthesia induction. The PECS II block includes 15 mL of 0.25% Bupivacaine injected into the pecto-serratus plane and 10 mL of 0.25% Bupivacaine into the interpectoral plane at the T3-T4 level. The superficial PIP block includes 10 mL of 0.25% Bupivacaine injected between the pectoralis major and external intercostal muscles at the T4-T5 level. Total local anesthetic volume is 35 mL.",[13],"Procedure: Combined PECS II and Superficial PIP Block",{"label":15,"type":16,"description":17,"interventionNames":18},"Thoracic Paravertebral Block Group","ACTIVE_COMPARATOR","Participants receive an ultrasound-guided Thoracic Paravertebral Block (TPVB) in the lateral decubitus position following general anesthesia induction. Injection of 5 mL 0.25% Bupivacaine per level is administered into the paravertebral space at thoracic levels T4 and T6. Total local anesthetic volume is 10 mL.",[19],"Procedure: Thoracic paravertebral block (TPVB)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Combined PECS II and Superficial PIP Block","Ultrasound-guided regional nerve block administration consisting of PECS II block (25 mL 0.25% Bupivacaine) and superficial PIP block (10 mL 0.25% Bupivacaine) post-induction of general anesthesia prior to surgical incision.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Thoracic paravertebral block (TPVB)","Ultrasound-guided regional nerve block administration consisting of TPVB with 0.25% Bupivacaine (5 mL at T4 level and 5 mL at T6 level) post-induction of general anesthesia prior to surgical incision.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Annisa Annisa, Anesthesiologist","CONTACT","81317235246","+62","annisa157sasa@gmail.com",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Jakarta","DKI Jakarta","11420","Indonesia","ID",{"type":47,"coordinates":48},"Point",[49,50],106.84513,-6.21462,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Annisa","Anesthesiologist","100649711","analgesic-efficacy-of-combined-pecs-ii-and-pip-block-versus-thoracic-paravertebral-block-post-mastectomy-100649711",false,"NCT07738770","Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy","Analgesic Efficacy Comparison of Combined PECS II and Superficial Parasternal Intercostal Plane (PIP) Block Versus Thoracic Paravertebral Block Post-Mastectomy: An Assessment of Pain Severity, Analgesia Duration, and Recovery Quality","PECS-TPVB","Inclusion Criteria:\n\n1. Female patients aged 18 to 60 years.\n2. Scheduled for breast cancer surgery (mastectomy with or without axillary lymph node dissection \\[ALND\\]).\n3. American Society of Anesthesiologists (ASA) physical status I to III.\n4. Provided signed written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patient refusal to participate in the study.\n2. Known allergy to local anesthetics or study medications (e.g., bupivacaine, ketorolac, morphine).\n3. Coagulation disorders or coagulopathy.\n4. Mastectomy procedure with immediate breast reconstruction.\n5. Pre-existing chronic cancer pain with active usage of strong opioids (e.g., morphine, fentanyl).\n6. Cognitive impairment or inability to comprehend the pain assessment scale (NRS).\n7. Pregnancy.\n8. Active infection at the planned regional block injection site.","FEMALE","18 Years","60 Years",{"count":70,"type":71},72,"ESTIMATED","INTERVENTIONAL",[74],"NA","Postoperative pain management is crucial for patients undergoing mastectomy for breast cancer. Regional analgesia techniques, such as the Thoracic Paravertebral Block (TPVB), are commonly used to reduce pain and opioid consumption; however, TPVB carries potential risks, including pneumothorax. Interfascial plane blocks, specifically the Pectoral Nerve II (PECS II) block combined with the Superficial Parasternal Intercostal Plane (PIP) block, have emerged as alternative techniques to provide comprehensive analgesia to both the lateral and anterior chest wall.\n\nThe purpose of this randomized controlled trial is to evaluate and compare the analgesic efficacy and quality of postoperative recovery between a combination of ultrasound-guided PECS II and PIP blocks versus the standard Thoracic Paravertebral Block (TPVB) in patients undergoing mastectomy with or without axillary lymph node dissection (ALND).\n\nParticipants will be randomly assigned to receive either the combined PECS II and PIP block or the TPVB following general anesthesia induction. Pain scores, total opioid consumption, time to first analgesic request, quality of recovery using the QoR-15 questionnaire, and potential block-related complications will be monitored and compared over the 24-hour postoperative period.",[77,78,79,80,81,82,83,84],"Acute Pain","Post Operative Analgesia","Post Operative Pain, Acute","Breast Cancer","Mastectomy","Regional Anaesthesia","Analgesia Duration","Quality of Recovery (QoR-15)",[86,87,88,89,81,80,90,91],"Pectoral Nerve Block","PECS II Block","Parasternal Intercostal Plane Block","Thoracic Paravertebral Block","Postoperative Analgesia","Quality of Recovery","2026-07-28",{"date":94,"type":95},"2026-07-31","ACTUAL",{"date":97,"type":95},"2026-06-29",{"date":99,"type":71},"2026-12-31",{"name":5,"class":6},1]