[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06982027":3,"trial-entities:NCT06982027":86,"trial-summary:NCT06982027":90},{"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":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":51,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":67,"locations":70,"central_contacts":79,"overall_officials":80,"references":84,"see_also_links":85},"NCT06982027","STUDY00004642","Peripheral Regional Blockade and EMG","Assessment of Peripheral Regional Anesthetic Blockade Using a Non-Invasive Surface Electromyogram (EMG) on the Affected and Unaffected Extremity","ENROLLING_BY_INVITATION","2027-12","2025-10","2025-10-30","2025-09-03","Nationwide Children's Hospital","OTHER",false,"The investigators are studying a type of technology that is already used called surface electromyography (EMG). This measures and records electrical activity using sensor stickers in a non-invasive way. The purpose of this study is to use a prototype\u002Ftest surface EMG machine to measure how well regional anesthesia (nerve block) is working. This device is non-invasive and being used for research use as an unapproved medical device. The information may teach us how to give nerve blocks more safely and effectively.\n\nStudy participation: Subjects having surgery will have the surface EMG sensor stickers placed on their arms or legs before surgery. These will stay on during surgery and for part of recovery.\n\nStudy visits: The study will consist of 1 visit that starts in the pre-operative area, through the surgery, and for part of recovery time after surgery.","This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize peripheral nerve blockade (upper or lower extremity) in pediatric, adolescent, and young adult patients undergoing surgery. We also aim to quantify the impact of sevoflurane (general anesthesia) on basal muscle tone based on EMG changes.\n\nHypothesis: EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.",[19],"Surgery",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},100,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","BlockSynop surface electromyography device","The EMG monitor uses non-invasive surface electrodes that measures electrical activity in response to muscle stimulation. After all electrodes have been placed on the patient, the electrodes will be connected to a prototype non-significant risk device (NSR) BlockSynop surface electromyography device and monitoring of sEMG signal will begin. The device is a non-invasive and non-significant risk device.",[33],"General Anesthesia with peripheral regional block",{"type":35,"name":36,"description":37,"armGroupLabels":38},"PROCEDURE","Peripheral nerve block","An injection of numbing medicine near a specific nerve or group of nerves to numb the part of the body undergoing surgery.",[33],[40,44,48],{"measure":41,"description":42,"timeFrame":43},"Determine onset of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.","Performance of non-invasive surface EMG following administration of peripheral nerve blockade + general anesthesia. This will be assessed by EMG signal amplitude.","Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery- up to one day.",{"measure":45,"description":46,"timeFrame":47},"Determine resolution of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.","Performance of non-invasive surface EMG following administration of peripheral nerve blockade and general anesthesia. This will be assessed by EMG signal amplitude.","Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.",{"measure":49,"description":50,"timeFrame":47},"Determine density of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.","Performance of non-invasive surface EMG following administration of peripheral nerve block and general anesthesia. This will be assessed by EMG signal amplitude.",[52],{"measure":53,"description":53,"timeFrame":54},"Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.","Intraoperative time frame. Timeframe being day of surgery.","ALL","0 Years","21 Years",{"inclusion":59,"exclusion":62,"raw_text":66},[60,61],"Patients ≤ 21 years of age","Patient presenting for a surgical procedure in which GA and a peripheral regional block will be used",[63,64,65],"Patients \\> 21 years of age","Parent \u002F patient refusal","Premature infants; neuromuscular disease; systemic infection; hemodynamic instability; coagulation disorder; degenerative CNS abnormality that precludes regional anesthesia; and local anesthetic allergy; pregnant women.","Inclusion Criteria:\n\n* Patients ≤ 21 years of age\n* Patient presenting for a surgical procedure in which GA and a peripheral regional block will be used\n\nExclusion Criteria:\n\n* Patients \\> 21 years of age\n* Parent \u002F patient refusal\n* Premature infants; neuromuscular disease; systemic infection; hemodynamic instability; coagulation disorder; degenerative CNS abnormality that precludes regional anesthesia; and local anesthetic allergy; pregnant women.",[68,69],"CHILD","ADULT",[71],{"facility":13,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Columbus","Ohio","43205","United States",{"lat":77,"lon":78},39.96118,-82.99879,[],[81],{"name":82,"affiliation":13,"role":83},"Grant Heydinger, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Surgical Procedure",[],{"nct_id":4,"found":15,"summary":91,"prompt_version":91},null]