[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07644923":3,"trial-entities:NCT07644923":113,"trial-summary:NCT07644923":116},{"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":54,"secondary_outcomes":62,"sex":66,"minimum_age":67,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":90,"locations":93,"central_contacts":101,"overall_officials":107,"references":111,"see_also_links":112},"NCT07644923","24-01580","Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation","A Randomized, Single-Blinded, Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation","NOT_YET_RECRUITING","2029-02-01","2026-06","2026-06-12","2026-08-01","NYU Langone Health","OTHER",false,"This study is a prospective randomized trial examining the effect of tranexamic acid (TXA) and aminocaproic acid (ε-Ahx) with local anesthetics and thrombin in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.\n\nAll surgical created wounds for any hand surgery will be treated in a randomized fashion with the following four arms:\n\n1. Bupivacaine + lidocaine\n2. Bupivacaine + lidocaine + thrombin\n3. Bupivacaine + lidocaine + thrombin + tranexamic acid\n4. Bupivacaine + lidocaine + thrombin + aminocaproic acid\n\nAll are applied topically to surgical bed prior to closure of skin.",null,[19],"Postoperative Pain",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"PHASE4",{"count":26,"type":27},40,"ESTIMATED",[29,38,42,46,50],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Bupivacaine","5 ml of 0.25% bupivacaine",[34,35,36,37],"Bupivacaine + lidocaine","Bupivacaine + lidocaine + thrombin","Bupivacaine + lidocaine + thrombin + aminocaproic acid","Bupivacaine + lidocaine + thrombin + tranexamic acid",{"type":30,"name":39,"description":40,"armGroupLabels":41},"Lidocaine","5 ml of 1% lidocaine",[34,35,36,37],{"type":30,"name":43,"description":44,"armGroupLabels":45},"Thrombin","10000 units of thrombin",[35,36,37],{"type":30,"name":47,"description":48,"armGroupLabels":49},"Tranexamic acid","500 mg of tranexamic acid",[37],{"type":30,"name":51,"description":52,"armGroupLabels":53},"Aminocaproic acid","1000 mg of aminocaproic acid",[36],[55,59],{"measure":56,"description":57,"timeFrame":58},"Pre-Operative Pain","Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).","Baseline (Day of Surgery)",{"measure":60,"description":57,"timeFrame":61},"Post-Operative Pain","Up to Day 14 Post-Operative",[63],{"measure":64,"description":65,"timeFrame":61},"Number of Opioid Prescription Pills Used","Opioid prescriptions (Norco 5\u002F325 mg) will be given to patients post operatively. Total number of pills taken up until post operative day 14 will be recorded by the patient.","ALL","18 Years",{"inclusion":69,"exclusion":72,"raw_text":89},[70,71],"Age 18 or older","Any patient undergoing elective hand surgery",[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"Any patient with a traumatic or infected open wound (only surgically created wounds will be included)","History of chronic pain","History of narcotic addiction","History of recreational drug dependency","History of psychiatric pathology","Allergy or hypersensitivity to local anesthetics, recombinant human thrombin or tranexamic acid","History of coagulopathy or active thromboembolic disease","Any patient receiving a supra\u002Finfraclavicular block for anesthesia","Pregnancy","Hypersensitivity to hamster proteins","History of seizures","Significant renal impairment (chronic kidney disease stage 3 or greater)","History of retinal vascular disease or history of unexplained visual symptoms","Active upper urinary tract bleeding","History of known hypercoagulable disorder, prior thromboembolic events, or active clotting disorders","History of severe hepatic dysfunction (active hepatitis or steatohepatitis, hepatic fibrosis considered cirrhosis)","Inclusion Criteria:\n\n* Age 18 or older\n* Any patient undergoing elective hand surgery\n\nExclusion Criteria:\n\n* Any patient with a traumatic or infected open wound (only surgically created wounds will be included)\n* History of chronic pain\n* History of narcotic addiction\n* History of recreational drug dependency\n* History of psychiatric pathology\n* Allergy or hypersensitivity to local anesthetics, recombinant human thrombin or tranexamic acid\n* History of coagulopathy or active thromboembolic disease\n* Any patient receiving a supra\u002Finfraclavicular block for anesthesia\n* Pregnancy\n* Hypersensitivity to hamster proteins\n* History of seizures\n* Significant renal impairment (chronic kidney disease stage 3 or greater)\n* History of retinal vascular disease or history of unexplained visual symptoms\n* Active upper urinary tract bleeding\n* History of known hypercoagulable disorder, prior thromboembolic events, or active clotting disorders\n* History of severe hepatic dysfunction (active hepatitis or steatohepatitis, hepatic fibrosis considered cirrhosis)",[91,92],"ADULT","OLDER_ADULT",[94],{"facility":13,"city":95,"state":95,"zip":96,"country":97,"geoPoint":98},"New York","10016","United States",{"lat":99,"lon":100},40.71427,-74.00597,[102],{"name":103,"role":104,"phone":105,"email":106},"Tom Calahan","CONTACT","929-455-5826","Thomas.Calahan@nyulangone.org",[108],{"name":109,"affiliation":13,"role":110},"David Chiu, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":115},[60],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]