[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04575688":3,"trial-entities:NCT04575688":143,"trial-summary:NCT04575688":147},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":70,"sex":102,"minimum_age":103,"maximum_age":104,"healthy_volunteers":15,"eligibility_criteria":105,"std_ages":123,"locations":126,"central_contacts":136,"overall_officials":137,"references":141,"see_also_links":142},"NCT04575688","19-06453-FB","Periarticular Injection Versus Popliteal Block","A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle\u002FHindfoot Osteotomy or Fusion and Ankle Fractures","ENROLLING_BY_INVITATION","2027-02-28","2025-12","2025-12-24","2021-07-13","Campbell Clinic","OTHER",false,"This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.","This is a prospective, randomized, controlled research study of two perioperative standards of care for managing post operative pain. The first standard of care procedure is the periarticular injection; the second is the popiteal block.",[19,20],"Foot Surgery","Ankle Surgery",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},100,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Exparel","Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.",[35],"Periarticular Injection",[35],{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"Bupivicaine","Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.",[41],"Popliteal Block",[43],"Peripheral Nerve Injection",[45,49,52,54,56,58,60,62,64,66,68],{"measure":46,"description":47,"timeFrame":48},"Visual Analog Score","Patient reported pain score from zero to ten where zero is no pain and ten is the most pain","Postoperative hour 3",{"measure":50,"description":51,"timeFrame":48},"Evidence of motor block","Patient reported yes\u002Fno answer to survey question: \"Are you able to wiggle your toes?\"",{"measure":46,"description":47,"timeFrame":53},"Postoperative hour 6",{"measure":46,"description":47,"timeFrame":55},"Postoperative hour 12",{"measure":46,"description":47,"timeFrame":57},"Postoperative hour 24",{"measure":46,"description":47,"timeFrame":59},"Postoperative hour 36",{"measure":46,"description":47,"timeFrame":61},"Postoperative hour 48",{"measure":46,"description":47,"timeFrame":63},"Postoperative hour 72",{"measure":46,"description":47,"timeFrame":65},"Postoperative week 2",{"measure":46,"description":47,"timeFrame":67},"Postoperative week 4-6",{"measure":46,"description":47,"timeFrame":69},"Postoperative week 12",[71,75,78,82,85,88,91,92,93,96,97,98,99],{"measure":72,"description":73,"timeFrame":74},"Document pain medication prescribed immediately after surgery","Pain medication prescribed immediately after the surgery will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed immediately after surgery, to include opiate name, dose, and number of pills prescribed.","Immediately after surgery",{"measure":76,"description":77,"timeFrame":65},"Satisfaction with pain control: survey question","Patient reported 7-point Likert scale answer to survey question: \"How satisfied are you with your pain control?\" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.",{"measure":79,"description":80,"timeFrame":81},"Neuralgia symptoms: survey question","Patient reported yes\u002Fno answer to survey question: \"Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?\" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.","Postoperative week two",{"measure":83,"description":84,"timeFrame":65},"Pill count","Patient reported fill-in-the-blank answer to survey question: \"Total number of pain pills taken during this time.\"",{"measure":86,"description":87,"timeFrame":65},"Document pain medication prescribed at postoperative week 2","Pain medication prescribed at postoperative week 2 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 2, to include opiate name, dose, and number of pills prescribed.",{"measure":76,"description":89,"timeFrame":90},"Patient reported 7-point Likert scale answer to survey question: \"How satisfied are you with your pain control?\" Patient reported 7-point Likert scale answer to survey question: \"How satisfied are you with your pain control?\" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.","Postoperative week 6",{"measure":79,"description":80,"timeFrame":90},{"measure":83,"description":84,"timeFrame":90},{"measure":94,"description":95,"timeFrame":90},"Document pain medication prescribed at postoperative week 6","Pain medication prescribed at postoperative week 6 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 6, to include opiate name, dose, and number of pills prescribed.",{"measure":76,"description":89,"timeFrame":69},{"measure":79,"description":80,"timeFrame":69},{"measure":83,"description":84,"timeFrame":69},{"measure":100,"description":101,"timeFrame":69},"Document pain medication prescribed at postoperative week 12","Pain medication prescribed at postoperative week 12 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 12, to include opiate name, dose, and number of pills prescribed.","ALL","18 Years","80 Years",{"inclusion":106,"exclusion":114,"raw_text":122},[107,108,109,110,111,112,113],"Ankle or hindfoot osteotomy or ankle fracture repair","Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)","18-80 years of age","ASA I-III with medical clearances as needed","Fluent ub verbal and written English","Willing and able to comply with study instruction and commit to all follow-up visits for theduration of the study","Willing and able to provide written consent",[115,116,117,118,119,120,121],"Diagnosed with chronic pain syndrome","History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents","Injury associated with workers' compensation","Surgery to be performed at a hospital","Diagnosed with peripheral neuropathy","Hbg A1C is \\> 7 mg\u002Fdl in diabetic patients only","Long term (chronic) preoperative narcotic usage","Inclusion Criteria:\n\n* Ankle or hindfoot osteotomy or ankle fracture repair\n* Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)\n* 18-80 years of age\n* ASA I-III with medical clearances as needed\n* Fluent ub verbal and written English\n* Willing and able to comply with study instruction and commit to all follow-up visits for theduration of the study\n* Willing and able to provide written consent\n\nExclusion Criteria:\n\n* Diagnosed with chronic pain syndrome\n* History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents\n* Injury associated with workers' compensation\n* Surgery to be performed at a hospital\n* Diagnosed with peripheral neuropathy\n* Hbg A1C is \\> 7 mg\u002Fdl in diabetic patients only\n* Long term (chronic) preoperative narcotic usage",[124,125],"ADULT","OLDER_ADULT",[127],{"facility":128,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"A","Germantown","Tennessee","38138","United States",{"lat":134,"lon":135},35.08676,-89.81009,[],[138],{"name":139,"affiliation":13,"role":140},"Garnett A Murphy, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":144,"biomarkers":146},[145,19],"Acne surgery",[],{"nct_id":4,"found":148,"summary":149,"prompt_version":159},true,{"design":150,"status":151,"heading":152,"summary":153,"follow_up":154,"word_count":155,"commitments":156,"compensation":157,"drugs_mentioned":158},"This is a randomized, controlled study comparing two pain management methods. About 100 participants are planned for this study.","completed","Periarticular Injection Versus Popliteal Block for Foot and Ankle Surgery","This study is comparing two common ways to manage pain after foot or ankle surgery: a periarticular injection of Exparel, or a popliteal block using Bupivicaine. Researchers want to see which method is more effective and safer for controlling pain after hindfoot or ankle osteotomy (bone cutting), fusion, or ankle fracture repair. You may be able to join if you are between 18 and 80 years old, having one of these surgeries at Campbell Surgery Center, and can speak and read English. The study will measure pain levels using a Visual Analog Score and check for motor block (muscle weakness) at 3 and 6 hours after surgery to see how well each treatment works. The current status of this study is unclear.","Pain levels and motor block will be measured at 3 and 6 hours after surgery.",122,"You would need to comply with study instructions and attend all follow-up visits for the duration of the study.","Not stated in the trial record.",[32,38],"v2"]