[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649711":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":41,"studyPopulation":30,"armGroups":42,"interventions":55,"overallOfficials":30,"centralContacts":65,"locations":72,"responsibleParty":88,"collaborators":30,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":30,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":119,"overallStatus":74,"whyStopped":30,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Dharmais National Cancer Center Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":30},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Postoperative Quality of Recovery Score (QoR-15)","Patient-reported quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, where higher scores indicate better overall recovery quality post-surgery.","24 hours postoperatively",{"measure":14,"description":15,"timeFrame":16},"Postoperative Pain Severity (NRS)","Pain severity evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements are recorded separately at rest and during active movement (shoulder joint movement \u002F arm elevation).","Postoperative hours 0, 6, 12, and 24",{"measure":18,"description":19,"timeFrame":20},"Duration of Analgesia","Time elapsed from the completion of surgery (extubation\u002Farrival at recovery room) to the patient's first request or activation of the Patient-Controlled Analgesia (PCA) morphine device. Measured in minutes\u002Fhours.","Up to 24 hours postoperatively",[22,26],{"measure":23,"description":24,"timeFrame":25},"Regional Block Procedure Execution Time","Total time taken to perform the assigned regional block, measured in seconds\u002Fminutes from initial patient positioning and USG scanning until the completion of local anesthetic injection.","Intraoperative (during regional block administration)",{"measure":27,"description":28,"timeFrame":29},"Block-Related Complications","Number of participants experiencing procedure- or drug-related complications, including Local Anesthetic Systemic Toxicity (LAST), injection site hematoma, injection site infection, and pneumothorax.","Intraoperative through 24 hours postoperatively",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","This study is a prospective, single-blind, randomized controlled trial designed to compare the analgesic efficacy and recovery outcomes of a combined Pectoral Nerve II (PECS II) and Superficial Parasternal Intercostal Plane (PIP) block versus a Thoracic Paravertebral Block (TPVB) in breast cancer patients undergoing mastectomy with or without axillary lymph node dissection. The intervention group receives an ultrasound-guided combination of PECS II and superficial PIP blocks, while the control group receives an ultrasound-guided TPVB. The study focuses on evaluating postoperative pain intensity (Numeric Rating Scale), quality of recovery (QoR-15 questionnaire), duration of analgesia, total postoperative opioid consumption, execution time, and block-related complications over a 24-hour postoperative period.","SUPPORTIVE_CARE",{"masking":37,"maskingDescription":38,"whoMasked":39},"SINGLE","This trial employs a single-blind masking design in which outcome assessors and clinical staff responsible for postoperative care-including recovery room nurses, ward physicians, and research assistants-are blinded to the treatment allocation. The regional block procedures (combined PECS II + PIP block or Thoracic Paravertebral Block) are performed intraoperatively by designated regional anesthesiologists who are not involved in postoperative outcome assessment or data collection, ensuring an unbiased evaluation of pain scores, quality of recovery, and analgesia duration.",[40],"PARTICIPANT","Breast cancer surgery, particularly mastectomy with or without axillary lymph node dissection (ALND), is associated with significant acute postoperative pain. Inadequate pain control in the immediate postoperative period can prolong hospital stay, delay functional recovery, and increase the risk of persistent post-mastectomy pain syndrome. While Thoracic Paravertebral Block (TPVB) has long been considered a gold standard for unilateral thoracic surgery analgesia, its technical difficulty and risk of serious complications such as pneumothorax and systemic toxicity prompt the search for safer alternatives.\n\nThe PECS II block targets the lateral and medial pectoral nerves, intercostobrachial nerve, and lateral cutaneous branches of intercostal nerves T2-T6. However, it may not consistently cover the anterior cutaneous branches near the sternum. Combining the PECS II block with a Superficial Parasternal Intercostal Plane (PIP) block aims to provide complete coverage of both the lateral and anterior thoracic wall, potentially offering comparable or superior analgesia to TPVB with a lower complication profile.\n\nIn this single-blind randomized controlled trial conducted at Dharmais Cancer Hospital, eligible female patients scheduled for mastectomy are randomized into two parallel groups:\n\n1. Intervention Group: Receives an ultrasound-guided combination of PECS II block (25 mL 0.25% Bupivacaine) and Superficial PIP block (10 mL 0.25% Bupivacaine) prior to surgical incision.\n2. Control Group: Receives an ultrasound-guided Thoracic Paravertebral Block at T4 and T6 levels (10 mL total of 0.25% Bupivacaine).\n\nStandardized general anesthesia and intraoperative monitoring (including hemodynamics and qNOX index for depth of analgesia) are maintained for all subjects. Postoperatively, patients receive standard oral paracetamol and IV ketorolac, supplemented with IV Morphine via a Patient-Controlled Analgesia (PCA) device.\n\nStudy endpoints include Numeric Rating Scale (NRS) pain scores evaluated at rest and movement at 0, 6, 12, and 24 hours post-surgery; quality of recovery measured via the QoR-15 questionnaire at 24 hours; time to first PCA activation (duration of analgesia); total 24-hour morphine consumption; and monitoring for complications including local anesthetic systemic toxicity (LAST), hematoma, and pneumothorax.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"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.",[48],"Procedure: Combined PECS II and Superficial PIP Block",{"label":50,"type":51,"description":52,"interventionNames":53},"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.",[54],"Procedure: Thoracic paravertebral block (TPVB)",[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":30},"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.",[44],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":30},"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.",[50],[66],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Annisa Annisa, Anesthesiologist","CONTACT","81317235246","+62","annisa157sasa@gmail.com",[73],{"facility":5,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"RECRUITING","Jakarta","DKI Jakarta","11420","Indonesia","ID",{"type":81,"coordinates":82},"Point",[83,84],106.84513,-6.21462,{"lat":84,"lon":83},[87],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"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":104,"type":105},72,"ESTIMATED","INTERVENTIONAL",[108],"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.",[111,112,113,114,115,116,117,118],"Acute Pain","Post Operative Analgesia","Post Operative Pain, Acute","Breast Cancer","Mastectomy","Regional Anaesthesia","Analgesia Duration","Quality of Recovery (QoR-15)",[120,121,122,123,115,114,124,125],"Pectoral Nerve Block","PECS II Block","Parasternal Intercostal Plane Block","Thoracic Paravertebral Block","Postoperative Analgesia","Quality of Recovery","2026-07-28",{"date":128,"type":129},"2026-07-31","ACTUAL",{"date":131,"type":129},"2026-06-29",{"date":133,"type":105},"2026-12-31",{"name":5,"class":6},1]