[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508877":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":50,"locations":58,"responsibleParty":76,"collaborators":30,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":30,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":30,"enrollmentInfo":87,"targetDuration":30,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":30,"overallStatus":60,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Swedish Medical Center","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"local intercostal nerve block","ACTIVE_COMPARATOR","Patients receiving intercostal blocks will receive a total of 1.0 cc\u002Fkg of 0.25% Bupivacaine + epinephrine. This will be divided into two-thirds allocated for use in the chest\u002Fintercostal block and one-third allocated for use in the abdomen.",[13,14],"Procedure: Local intercostal nerve block","Procedure: Thoracic epidural catheter",{"label":16,"type":10,"description":17,"interventionNames":18},"cryo-ablation plus intercostal nerve block","Patients receiving cryo-analgesia and intercostal blocks, the patient will receive cryo-ablation prior to the intercostal block. The cryo-ablation will occur 2 cm from the sympathetic chain 2 intercostal spaces above and 2 intercostal spaces below the access incision. The patient will also receive a total of 1.0 cc\u002Fkg of 0.25% Bupivacaine + epinephrine. This will be divided into two-thirds allocated for use in the chest\u002Fintercostal block and one-third allocated for use in the abdomen.",[19,14],"Procedure: Cryo-analgesia and intercostal nerve block",{"label":21,"type":10,"description":22,"interventionNames":23},"serratus plane catheter plus intercostal nerve block","Patients receiving serratus plane catheter blocks and intercostal nerve blocks, a total of 1.0 cc\u002Fkg of 0.25% Bupivacaine + epinephrine will be administered. A total of 20 cc of the weight-based calculation will be reserved for the serratus plane catheter. The remaining local anesthetic will be divided into two-thirds for the chest and one-third for the abdomen. Patients with serratus plane catheters will have an ongoing infusion of 0.2% ropivacaine at 8 ml per hour. The serratus plane catheters will also receive a bolus of 20 ml of 0.25% bupivacaine with epinephrine on Post Operative Day (POD) #1, 2, 3, 4, and 5 by the pain service.",[24,14],"Procedure: Serratus plane catheter blocks and intercostal nerve blocks",[26,31,37,41],{"type":27,"name":28,"description":11,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Local intercostal nerve block",[9],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Cryo-analgesia and intercostal nerve block","The cryo-ablation will occur 2 cm from the sympathetic chain 2 intercostal spaces above and 2 intercostal spaces below the access incision. The patient will also receive a total of 1.2 cc\u002Fkg of 0.25% Bupivacaine + epinephrine. This will be divided into two-thirds allocated for use in the chest\u002Fintercostal block and one-third allocated for use in the abdomen.",[16],[36],"Cryo-ablation",{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":30},"Serratus plane catheter blocks and intercostal nerve blocks","A total of 1.2 cc\u002Fkg of 0.25% Bupivacaine + epinephrine will be administered. A total of 20 cc of the weight-based calculation will be reserved for the serratus plane catheter. The remaining local anesthetic will be divided into two-thirds for the chest and one-third for the abdomen. Patients with serratus plane catheters will have an ongoing infusion of 0.2% ropivacaine at 8 ml per hour. The serratus plane catheters will also receive a bolus of 20 ml of 0.25% bupivacaine with epinephrine on POD #1, 2, 3, 4, and 5 by the pain service.",[21],{"type":27,"name":42,"description":43,"armGroupLabels":44,"otherNames":30},"Thoracic epidural catheter","The pain service and thoracic surgery attending physician will assess if the patient's pain is not well-controlled using the pain modality they are randomized to. If additional pain control is needed, this will likely consist of a thoracic epidural catheter.\n\nAny additional pain control will be added as an adjunct to the study arm and will be noted in the data set.",[16,9,21],[46],{"name":47,"affiliation":48,"role":49},"Brian Louie, M.D.","Swedish Cancer Institute","PRINCIPAL_INVESTIGATOR",[51,55],{"name":47,"role":52,"phone":53,"phoneExt":30,"email":54},"CONTACT","(206) 215-6800","brian.louie@swedish.org",{"name":56,"role":52,"phone":53,"phoneExt":30,"email":57},"Meagan Ivy, M.D.","megan.ivy@swedish.org",[59],{"facility":48,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Seattle","Washington","98104","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-122.33207,47.60621,{"lat":70,"lon":69},[73,75],{"name":47,"role":52,"phone":74,"phoneExt":30,"email":54},"206-215-6800",{"name":56,"role":52,"phone":74,"phoneExt":30,"email":57},{"type":77,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100508877","phase-1-minimally-invasive-esophagectomy-pain-control-trial-100508877",false,"NCT05906134","Minimally Invasive Esophagectomy Pain Control Trial","A Randomized Controlled Trial Comparing Local Intercostal Nerve Blocks, Cryo-ablation Plus Intercostal Nerve Blocks, and Serratus Plane Catheter Plus Intercostal Nerve Blocks After Minimally Invasive Esophagectomy","Inclusion Criteria:\n\nAll adult individuals who undergo an esophagectomy with an intended minimally invasive approach of the chest at Swedish Medical Center-First Hill. These approaches include:\n\n* 3-hole with R video-assisted thoracoscopic surgery (VATS)\n* Ivor Lewis R VATS\n\nExclusion Criteria:\n\n* Age \\\u003C18\n* Unable to consent\n* Additional surgical procedures planned\n* Patients with previous thoracic surgery\n* Patient with chronic pain on a daily regimen of narcotics\n* Non-English speaking\n* Contraindications to neuraxial anesthesia (ongoing anticoagulation, anticipated post-operative therapeutic anticoagulation, spinal cord stimulators, anatomic abnormalities preventing epidural placement)","ALL","18 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE1","PHASE2","A pilot randomized controlled trial comparing intercostal nerve blocks, cryo-ablation plus intercostal nerve blocks, and serratus plane catheter plus intercostal nerve blocks in patients undergoing esophagectomies with minimally invasive thoracic approaches.",[96,97],"Postoperative Pain, Acute","Postoperative Complications","2025-07-17",{"date":100,"type":101},"2025-07-23","ACTUAL",{"date":103,"type":101},"2022-04-26",{"date":105,"type":89},"2027-02",{"name":5,"class":6},1]