[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03976154":3,"trial-entities:NCT03976154":121,"trial-summary:NCT03976154":125},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":62,"sex":74,"minimum_age":75,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":87,"locations":90,"central_contacts":109,"overall_officials":118,"references":119,"see_also_links":120},"NCT03976154","122914","Effects of Fixation Technique On Thoracic Epidural Catheter Displacement","The Effects of Fixation Technique On Thoracic Epidural Catheter Displacement: A Single-Center Randomized Controlled Trial","RECRUITING","2025-12-31","2025-03","2025-03-07","2019-10-01","University of Utah","OTHER",false,"The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok fixation bandage, two common, widely used techniques for epidural fixation.",null,[19],"Thoracic Epidural",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},300,"ESTIMATED",[29],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Thoracic Epidural Catheter Fixation Techniques","All thoracic epidurals will be placed by a regional anesthesia resident or fellow under the direct supervision of an attending anesthesiologist using a standard epidural kit and in the paramedian approach.\n\nEpidural placement will occur preoperatively in the same manner as our current practice criterion. There will be no difference in placement of the epidural catheter between the control groups and the treatment group. After placement, catheters will be secured with either Dermabond, Mastisol, or a Grip-Lok fixation bandage, all with overlying Tegaderms.",[33,34,35],"Dermabond","Grip-lock","Mastisol",[37,41,44,47,50,53,56,59],{"measure":38,"description":39,"timeFrame":40},"Epidural catheter displacement immediately after surgery","Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm","immediately after surgery in PACU",{"measure":42,"description":39,"timeFrame":43},"Epidural catheter displacement day 1","24 hours post-operative",{"measure":45,"description":39,"timeFrame":46},"Epidural catheter displacement day 2","48 hours post-operative",{"measure":48,"description":39,"timeFrame":49},"Epidural catheter displacement day 3","72 hours post-operative",{"measure":51,"description":39,"timeFrame":52},"Epidural catheter displacement day 4","96 hours post-operative",{"measure":54,"description":39,"timeFrame":55},"Epidural catheter displacement day 5","120 hours post-operative",{"measure":57,"description":39,"timeFrame":58},"Epidural catheter displacement day 6","144 hours post-operative",{"measure":60,"description":39,"timeFrame":61},"Epidural catheter displacement day 7","168 hours post-operative",[63,67,70],{"measure":64,"description":65,"timeFrame":66},"Leakage","presence of any leakage from catheter fixation","immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7",{"measure":68,"description":69,"timeFrame":66},"Percent of patients with skin changes as measured by clinician subjective assessment","The clinician will subjectively assess any skin changes including induration or erythema",{"measure":71,"description":72,"timeFrame":73},"Opioid consumption","Daily oral morphine equivalent totals","daily up to 7 days post-operative","ALL","18 Years",{"inclusion":77,"exclusion":81,"raw_text":86},[78,79,80],"surgical patient","receiving a thoracic epidural","18 years of age or older",[82,83,84,85],"Patient refusal","allergy to adhesives or local anesthesia","pregnancy","contraindication to receiving an epidural including coagulopathy, infection, elevated ICP, or severe pre-existing neurologic disorders","Inclusion Criteria:\n\n* surgical patient\n* receiving a thoracic epidural\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Patient refusal\n* allergy to adhesives or local anesthesia\n* pregnancy\n* contraindication to receiving an epidural including coagulopathy, infection, elevated ICP, or severe pre-existing neurologic disorders",[88,89],"ADULT","OLDER_ADULT",[91],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":106},"University of Utah Health Sciences Center","Salt Lake City","Utah","84132","United States",[98,103],{"name":99,"role":100,"phone":101,"email":102},"Julia L. White","CONTACT","801-587-4806","julia.white@hsc.utah.edu",{"name":104,"role":105},"Harriet W. Hopf, MD","PRINCIPAL_INVESTIGATOR",{"lat":107,"lon":108},40.76078,-111.89105,[110,114],{"name":111,"role":100,"phone":112,"email":113},"Ami Stuart, PhD","8017934800","ami.stuart@hsc.utah.edu",{"name":115,"role":100,"phone":116,"email":117},"Adam Meier, DO","8015876393","adam.meier@hsc.utah.edu",[],[],[],{"nct_id":4,"conditions":122,"biomarkers":124},[123],"Surgical Procedure",[],{"nct_id":4,"found":126,"summary":127,"prompt_version":137},true,{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This interventional study plans to enroll 300 participants. It compares three different methods for securing thoracic epidural catheters.","completed","Study on Thoracic Epidural Catheter Fixation","This study is looking at different ways to secure a thoracic epidural catheter (a small tube placed in your back to deliver pain medicine). We want to see if Dermabond, a type of medical adhesive, works better than Mastisol or Grip-Lok, two commonly used methods, at keeping the catheter from moving. You may be able to join if you are having surgery and will receive a thoracic epidural, and are 18 years or older. We will measure how much the epidural catheter moves immediately after surgery, and then again 24 and 48 hours later. The current recruitment status is unclear.","Participants will be followed for epidural catheter displacement immediately after surgery, and then at 24 and 48 hours post-operative.",100,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]