[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06384664":3,"trial-entities:NCT06384664":118,"trial-summary:NCT06384664":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":63,"sex":75,"minimum_age":76,"maximum_age":16,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":91,"locations":94,"central_contacts":112,"overall_officials":114,"references":116,"see_also_links":117},"NCT06384664","HUM00241242","Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy","RECRUITING","2028-04","2025-08","2025-08-28","2024-06-03","University of Michigan","OTHER",false,"The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.",null,[18,19],"Pain, Postoperative","Intrathoracic Procedure",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},80,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DEVICE","Atricure's crysoSPHERE probe","Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.",[34],"Cryoablation",[36],"cryoablation",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":43},"PROCEDURE","Standard of Care","An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.",[42],"Intercostal nerve block",[42],[45,49,53,56,60],{"measure":46,"description":47,"timeFrame":48},"Severity of pain in the peri-operative period","Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity","Post-op day 1 and day of hospital discharge, approximately 3 days",{"measure":50,"description":51,"timeFrame":52},"Inflammatory cytokine levels as measured by blood samples","Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a","Pre-surgery, 6-hours after end of surgery and 24-hours after surgery",{"measure":54,"description":55,"timeFrame":52},"Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score","Correlations with the pain scores from outcome #1",{"measure":57,"description":58,"timeFrame":59},"Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)","Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys","baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop",{"measure":61,"description":62,"timeFrame":59},"Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)","assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment",[64,68,72],{"measure":65,"description":66,"timeFrame":67},"Quality of life score as measured by SF-36 Health questionnaire","36 item survey instrument","baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.",{"measure":69,"description":70,"timeFrame":71},"Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)","Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation.","Up to 180-days postop",{"measure":73,"description":74,"timeFrame":71},"Workflow\u002Ftime","Including items such as length of operating room use and length of hospital stay","ALL","18 Years",true,{"inclusion":79,"exclusion":82,"raw_text":90},[80,81],"Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine","Patient is opioid naïve",[83,84,85,86,87,88,89],"Patients who are pregnant","Patients with cognitive impairment","Patients with psychological disorders","Patients with prior thoracic surgery","Patients with fibromyalgia","Patients with redo ipsilateral thoracic surgery","Patients undergoing bilateral thoracotomy","Inclusion Criteria:\n\n* Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine\n* Patient is opioid naïve\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients with cognitive impairment\n* Patients with psychological disorders\n* Patients with prior thoracic surgery\n* Patients with fibromyalgia\n* Patients with redo ipsilateral thoracic surgery\n* Patients undergoing bilateral thoracotomy",[92,93],"ADULT","OLDER_ADULT",[95],{"facility":12,"status":7,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":109},"Ann Arbor","Michigan","48109","United States",[101,106],{"name":102,"role":103,"phone":104,"email":105},"Shari L Barnett","CONTACT","734-936-4561","shbailey@umich.edu",{"name":107,"role":108},"Rishindra Reddy, MD, MBA","PRINCIPAL_INVESTIGATOR",{"lat":110,"lon":111},42.27756,-83.74088,[113],{"name":102,"role":103,"phone":104,"email":105},[115],{"name":107,"affiliation":12,"role":108},[],[],{"nct_id":4,"conditions":119,"biomarkers":121},[120],"Post-Operative Pain",[],{"nct_id":4,"found":77,"summary":123,"prompt_version":133},{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This interventional study plans to enroll 80 participants. It compares two different pain control methods after chest surgery.","completed","Cryoablation for Pain After Thoracic Surgery","This study is looking at how well a procedure called cryoablation (freezing tissue with a device called a cryoSPHERE probe) works to control pain after chest surgery (thoracotomy or thoracoscopy). Researchers will compare cryoablation to the standard pain relief method, which is an intercostal nerve block (injecting numbing medicine around nerves). They want to see if cryoablation offers better pain control right after surgery and if it affects inflammation. You might be able to join if you are 18 or older, having certain chest surgeries at Michigan Medicine, and haven't used opioids before. The study aims to enroll 80 people.","Pain levels will be assessed for approximately 3 days after surgery, and blood samples will be taken up to 24 hours after surgery.",100,"You would have blood samples taken before surgery, and then 6 and 24 hours after surgery. Pain levels will be measured on post-operative day 1 and the day you leave the hospital.","Not stated in the trial record.",[],"v2"]