[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07174440":3,"trial-entities:NCT07174440":119,"trial-summary:NCT07174440":123},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":49,"secondary_outcomes":54,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":15,"eligibility_criteria":75,"std_ages":91,"locations":94,"central_contacts":109,"overall_officials":113,"references":117,"see_also_links":118},"NCT07174440","STUDY20241500","Contrast and Anesthetic Level With Lumbar Erector Spinae Plan (ESP) Block","Erector Spinae Plane Block in Patients Undergoing Lumbar Spine Fusion Surgery: Iohexol Spread, Extent of Block and Efficacy","RECRUITING","2027-01-25","2026-03","2026-03-11","2025-09-15","University Hospitals Cleveland Medical Center","OTHER",false,"As per usual care for spine surgery, participants will have their back cleaned with alcohol and a needle will be placed using ultrasound for the ESP block. Through the needle, a small catheter will be placed in the participants back and the needle removed. Approximately one hour prior to the start of surgery, a numbing medication (ropivacaine, similar to Novocaine) in combination with dexmedetomidine (a pain medicine that is used in nerve block and that is not a narcotic) and contrast dye (iohexol) will be injected through the catheter. Participants will then go through the QST procedure (test of buzzing sensation and temperature sensation through pads applied to their skin) to assess the numb areas and then head to the operating room. In the operating room, the catheter will be removed after the surgeon obtains baseline CT scan images of the spine. Once surgery is completed, investigators will record pain scores over the next four days in the hospital and the amount of pain medication needed for controlling pain related to the surgery.",null,[19],"Pain",[21,22],"Spinal surgery","ESP block","INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},32,"ESTIMATED",[31,37,40,44],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Ropivacaine (Epidural analgesia)","The block solution will consist of 1% ropivacaine 3 mg\u002FKg ideal body weight (IBW) mixed with dexmedetomidine 0.5 mcg\u002FKg IBW and diluted with 10 mL iohexol 300 mg\u002FmL and normal saline for a total volume of 40 mL. All medications used are standard of care",[36],"Spinal Surgery Participants",{"type":32,"name":38,"description":34,"armGroupLabels":39},"Dexmedetomidine",[36],{"type":32,"name":41,"description":42,"armGroupLabels":43},"Iohexol","The block solution will consist of 1% ropivacaine 3 mg\u002FKg ideal body weight (IBW) mixed with dexmedetomidine 0.5 mcg\u002FKg IBW and diluted with 10 mL iohexol 300 mg\u002FmL and normal saline for a total volume of 40 mL. All medications used are standard of care except for iohexol which is used for study purposes.",[36],{"type":45,"name":46,"description":47,"armGroupLabels":48},"PROCEDURE","QST Procedure","The QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas.",[36],[50],{"measure":51,"description":52,"timeFrame":53},"Verbal pain score as measured by the numerical rating scale (NRS)","NRS rates pain intensity on a scale of 0 to 10, with 0 being no pain and 10 being worst possible pain.","12 hours after surgery",[55,59,61,65,68],{"measure":56,"description":57,"timeFrame":58},"Patient-reported outcome to assess the quality of recovery as measured by the QoR-15","Concise, 15-item questionnaire that covers domains like physical comfort, emotional state, psychological support, physical independence, and pain. A higher QoR-15 score indicates a better quality of recovery.","Daily during hospital stay, up to 4 days",{"measure":60,"timeFrame":58},"Time to oral food intake as measured by patient report",{"measure":62,"description":63,"timeFrame":64},"Time to ambulation as measured by patient report","Patients will be asked daily if they are walking to the bathroom.","Daily during hospital stay, up to 4 days.",{"measure":66,"timeFrame":67},"Length of hospital stay as measured by medical record review","Up to 5 days",{"measure":69,"description":70,"timeFrame":71},"Number of intraoperative events as measured by medical record review.","Events include: hypotension, tachycardia, need for additional opioids beyond the study limit, and blood loss.","Up to 12 hours after surgery","ALL","21 Years","75 Years",{"inclusion":76,"exclusion":81,"raw_text":90},[77,78,79,80],"Age range: Adult patients 21-75 years of age","ASA status: I-III","Planned lumbar spine fusion involving no more than three levels","Ability to ambulate prior to surgery",[82,83,84,85,86,87,88,89],"Previous lumbar spine surgery","Metastatic cancer with involvement of the lumbar spine","eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2","Active liver disease (hepatitis or cirrhosis)","Confirmed allergy to ropivacaine, dexmedetomidine or iohexol","Cognitive impairment resulting in inability to rate pain scores","Patients receiving 30 mg or more of morphine equivalent daily dosing preoperatively","Pregnancy","Inclusion Criteria:\n\n* Age range: Adult patients 21-75 years of age\n* ASA status: I-III\n* Planned lumbar spine fusion involving no more than three levels\n* Ability to ambulate prior to surgery\n\nExclusion Criteria:\n\n* Previous lumbar spine surgery\n* Metastatic cancer with involvement of the lumbar spine\n* eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2\n* Active liver disease (hepatitis or cirrhosis)\n* Confirmed allergy to ropivacaine, dexmedetomidine or iohexol\n* Cognitive impairment resulting in inability to rate pain scores\n* Patients receiving 30 mg or more of morphine equivalent daily dosing preoperatively\n* Pregnancy",[92,93],"ADULT","OLDER_ADULT",[95],{"facility":13,"status":8,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":106},"Cleveland","Ohio","44106","United States",[101],{"name":102,"role":103,"phone":104,"email":105},"Ayse Ulucay, MD","CONTACT","216-844-3771","Ayse.Ulucay@UHhospitals.org",{"lat":107,"lon":108},41.4995,-81.69541,[110],{"name":111,"role":103,"phone":112,"email":105},"Sena Ulucay, MD","216-84-3771",[114],{"name":115,"affiliation":13,"role":116},"Salim Hayek, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":120,"biomarkers":122},[121],"Lumbar spinal fusion",[],{"nct_id":4,"found":124,"summary":125,"prompt_version":135},true,{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This is an interventional study with a planned enrollment of 32 participants. The phase of the study is not specified.","completed","Lumbar Erector Spinae Plane (ESP) Block for Pain Management","This study is looking at how well a nerve block called a Lumbar Erector Spinae Plane (ESP) block works to manage pain after spine surgery. Researchers are testing a combination of medications: ropivacaine (a numbing medicine similar to Novocaine), dexmedetomidine (a pain medicine that is not a narcotic), and iohexol (a contrast dye). You may be able to join if you are between 21 and 75 years old, have good kidney function (eGFR ≥ 60 mL\u002Fmin), and are having lumbar spine fusion surgery involving no more than three levels. The main goal is to see how much pain you report 12 hours after surgery. The current recruitment status is unclear.","Your pain will be measured 12 hours after surgery.",110,"You will have a catheter placed in your back for the ESP block. About an hour before surgery, the study medications will be injected, and you will undergo a QST procedure (a test of buzzing and temperature sensation) to check numb areas.","Not stated in the trial record.",[38,41],"v2"]