[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612520":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":49,"locations":55,"responsibleParty":72,"collaborators":75,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":53,"enrollmentInfo":90,"targetDuration":53,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":111,"whyStopped":53,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 \"LipoB-I\": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block","EXPERIMENTAL","Patients randomized to Arm 1 \"LipoB-I\" will receive Liposomal Bupivacaine (LipoB) as an intra-operative multi-level intercostal nerve block containing 266mg (20mL) of Liposomal Bupivacaine (Exparel®) combined with 50mg (20mL) of 0.25% Bupivacaine Hydrochloride, for a total of 40mL for the block.",[13],"Procedure: Arm 1 \"LipoB-I\": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2 \"LipoB-S\": Liposomal Bupivacaine via Serratus Anterior Plane Block","Patients randomized to Arm 2 \"LipoB-S\" will receive Liposomal Bupivacaine (LipoB) as an intra-operative serratus anterior plane block containing 266mg (20mL) of Liposomal Bupivacaine (Exparel®) combined with 50mg (20mL) of 0.25% Bupivacaine Hydrochloride, for a total of 40mL for the block.",[18],"Procedure: Arm 2 \"LipoB-S\": Liposomal Bupivacaine via Serratus Anterior Plane Block",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm 3 \"LipoB-C\": Liposomal Bupivacaine via Combination Block","Patients randomized to Arm 3 \"LipoB-C\" will receive Liposomal Bupivacaine (LipoB) as an intra-operative combination block (multi-level intercostal nerve block \\[ICNB\\] and serratus anterior plane block \\[SAPB\\]) with half the dose of Liposomal Bupivacaine administered in each block. Block solutions are as follows:\n\n10mL LipoB mixed with 10mL 0.25% Bupivacaine Hydrochloride and 20mL of saline, administered as SAPB by anesthesiologist immediately prior to incision while in the operating room\n\nAND\n\n10mL LipoB mixed with 10mL 0.25% Bupivacaine Hydrochloride and 20mL of saline administered as ICNB prior to closure in at least 5 intercostal spaces as determined by administering surgeon while in the operating room.",[23],"Procedure: Arm 3 \"LipoB-C\": Liposomal Bupivacaine Administered via Combination Block",[25,34,39],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","The anesthetic mixture is prepared by combining 266 mg (20 mL) of Liposomal Bupivacaine (Exparel®) with 50 mg (20 mL) of 0.25% Bupivacaine Hydrochloride, creating a mixture of 40 mL. This mixture is administered via multi-level intercostal nerve block (ICNB).\n\nOne injection is administered by a surgeon per intercostal space (ICS), given at the origin of the nerve space junction where the nerve and the inferior aspect of the rib meet after the nerve immerges from the intervertebral foramina. At least 5 mL, and no more than 8mL, will be injected in each ICS with the ideal injection consisting of 3 mL just beneath the pleura and 5 mL deeper in the intercostal muscular tissue for a total of 8 mL per ICS. Injections will be completed utilizing a 21-guage needle and two 20-mL syringes.",[9],[30,31,32,33],"Exparel","Multi-Level Intercostal Nerve Block","0.25% Bupivacaine Hydrochloride","Marcaine",{"type":26,"name":15,"description":35,"armGroupLabels":36,"otherNames":37},"The anesthetic mixture is prepared by combining 266 mg (20 mL) of Liposomal Bupivacaine (Exparel®) with 50 mg (20 mL) of 0.25% Bupivacaine Hydrochloride, creating a mixture of 40 mL. This mixture is administered via serratus anterior plane block.\n\nOne injection is administered by an anesthesiologist in the serratus anterior fascial plane, immediately prior to incision while in the operating room. The total volume of 40 mL is administered using a single-shot technique with a short-bevel, 21-guage needle, ensuring a negative aspiration for blood upon entry, no paresthesia on injection, and incremental injection under ultrasound guidance.",[15],[30,33,38,32],"Serratus Anterior Plane Block",{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Arm 3 \"LipoB-C\": Liposomal Bupivacaine Administered via Combination Block","Patients randomized to Arm 3 will receive both a multi-level intercostal nerve block (ICNB) and a serratus anterior plane block (SAPB), with each containing half the dose of Liposomal Bupivacaine (LipoB) as compared to when administered as a single block in Arm 1 and Arm 2. The mixtures are as follows:\n\n133mg (10mL) LipoB mixed with 25mg (10mL) 0.25% Bupivacaine Hydrochloride and 20mL of saline administered as SAPB by anesthesiologist immediately prior to incision while in the operating room\n\nAND\n\n133mg (10mL) LipoB mixed with 25mg (10mL) 0.25% Bupivacaine Hydrochloride and 20mL of saline administered as ICNB prior to closure in at least 5 intercostal spaces as determined by administering surgeon, while in the operating room.",[20],[30,33,32,44],"Combination Block",[46],{"name":47,"affiliation":5,"role":48},"Inderpal S Sarkaria, MD, MBA","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","214-645-7700",null,"Inderpal.Sarkaria@utsouthwestern.edu",[56],{"facility":57,"status":53,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Clements University Hospital at University of Texas Southwestern Medical Center","Dallas","Texas","75390","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-96.80667,32.78306,{"lat":67,"lon":66},[70,71],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},{"name":47,"role":48,"phone":53,"phoneExt":53,"email":53},{"type":48,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Inderpal Sarkaria","Chief of the Division of Thoracic Surgery and Professor of Thoracic Surgery at University of Texas Southwestern Medical Center, and Robert Tucker Hayes Foundation Distinguished Chair in Cardiothoracic Surgery",[76,78],{"name":77,"class":6},"The University of Texas at Dallas",{"name":79,"class":6},"Simmons Cancer Center","100612520","combination-versus-alone-liposomal-bupivacaine-blocks-in-minimally-invasive-thoracic-surgery-1-100612520",false,"NCT07254650","Combination Versus Alone Liposomal Bupivacaine Blocks in Minimally Invasive Thoracic Surgery-1","A Phase IIb, Randomized, Double-Blinded, Three-Arm Clinical Trial: The Study of Liposomal Bupivacaine Via Intercostal Nerve Block, Serratus Anterior Plane Block, or Combination Block for Pain Control After Robotic Thoracic Surgery","CALMS-1","Inclusion Criteria:\n\n* Plan to undergo planned (elective) minimally invasive isolated R-VATS procedure, to include pulmonary anatomic resections (anatomic lobectomy, segmentectomy, and wedge resection if performed robotically)\n* Age ≥ 18 years old\n* Ability to understand and capacity\u002Fwillingness to sign a written informed consent form\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* Unwilling to sign informed consent form, mentally challenged\u002Fdelayed, or lacking capacity\u002Funable to consent to participation in the trial own their own behalf\n* Vulnerable populations\n* Incarcerated individuals\n* Pregnant individuals\n* Breastfeeding individuals\n* Individuals with potentially altered pharmacokinetics and metabolism of study drugs\n* Renal failure: creatinine ≥ 2, or glomerular filtration rate \\\u003C 45 mL\u002Fmin\n* Hepatic failure: serum ammonia \\> 33 mcg\u002FdL and\u002For Child-Pugh \\> A\n* Individuals suffering from chronic pain\n* Individuals taking pre-operative narcotics\n* Patients undergoing emergent surgery or urgent surgery for acute, traumatic injuries\n* Patients undergoing extra-pleural resections, chest wall resection, pleurectomies, pleurodesis, and decortications\n* Planned concurrent abdominal procedure: for example, but not limited to, an esophagectomy\n* Patients requiring subcostal transversus abdominis plane (TAP) block\n* Use of a rib spreader during thoracic procedure\n* Patients admitted to the intensive care unit (ICU) post-operatively while sedated and intubated\n* Patients with major post-operative complications\n* Wedge resection for pulmonary bleb\n* Unanticipated pleurectomy, even if partial\n* Surgeon injects superficial wounds with LipoB","ALL","18 Years",{"count":91,"type":92},300,"ESTIMATED","INTERVENTIONAL",[95],"NA","The goal of this clinical trial is to assess how the location of local anesthetic medication affects pain control capabilities in adult patients undergoing thoracic(chest)-only minimally invasive surgery. The main questions it aims to answer are:\n\n* Is pain decreased when local analgesia is provided as a combination of serratus anterior plane block and intercostal nerve block when compared to either block administered individually?\n* How does location of local analgesia administration impact length-of-stay, cost-of-care, and quality-of-life?\n\nResearchers will compare three treatment options including long-acting local anesthetic (Exparel®) administered as (1) intercostal nerve block, (2) serratus anterior plane block, or (3) combination of intercostal nerve block and serratus anterior plane block to see if pain and opioid use are reduced dependent upon treatment group.\n\nAll participants will receive a local anesthetic nerve block. Participants will be asked to describe their pain after surgery and to answer various questionnaires before and after surgery.",[98],"Lung Cancer (Diagnosis)",[100,101,31,38,102,103,104,105,106,107,108,109,110],"Exparel®","Liposomal Bupivacaine","Robotic-Assisted Thoracic Surgery","Adult","Pulmonary Wedge Resection","Lobectomy","Pulmonary Segmentectomy","Pneumonectomy","Minimally-Invasive Thoracic Surgery","Pain Control","Regional Anesthetic Block","NOT_YET_RECRUITING","2026-05-26",{"date":114,"type":115},"2026-05-28","ACTUAL",{"date":117,"type":92},"2026-06",{"date":119,"type":92},"2028-01-01",{"name":5,"class":6},1]