[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06561035":3,"trial-entities:NCT06561035":97,"trial-summary:NCT06561035":101},{"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":38,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":77,"locations":81,"central_contacts":90,"overall_officials":91,"references":95,"see_also_links":96},"NCT06561035","24-09976-FB","ACL-R Opioid Sparing Study","Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery","ENROLLING_BY_INVITATION","2026-06","2024-08","2024-08-19","2024-09-01","Campbell Clinic","OTHER",null,"This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).","There is increased attention on opioid prescription patterns and post-operative narcotic consumption in light of the ongoing opioid crisis in the United States. Patients with opioid use disorders often have their first exposure to opioids following a medical or surgical procedure (Shah et al., 2019). Approximately 6% of patients who were opioid native preoperatively and received opioids postoperatively became long term users. As orthopedic surgeons account for approximately 8% of all dispensed opioid prescriptions (Volkow et al., 2011), surgeons have investigated the effectiveness of multimodal analgesic regimens in controlling post-operative pain and reducing the amount of opioid consumption. Recent studies have shown that an opiate sparing regimen consisted of nonsteroidal anti-inflammatory drugs can control post-operative pain adequately while reducing opioid consumption in patients who underwent arthroscopic knee or shoulder surgeries (Gazendam et al., 2022; Jones et al., 2022). Currently, there is no clear consensus on pain management regimen after anterior cruciate ligament reconstruction.\n\nThe purpose of this study is to 1) investigate the difference in pain score and opioid consumption among patients who receive the opioid-based protocol and those who receive opioid-sparing protocol; 2) minimize and potentially eliminate the utilization of narcotics following anterior cruciate ligament reconstruction (ACL-R) surgery.",[19],"Anterior Cruciate Ligament Injuries",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},56,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Opiate Sparing","Subjects will receive medications in the Opiate Sparing arm for pain control.",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Opiate Based","Subjects will receive medications in the Opiate Based arm for pain control.",[35],[39,43],{"measure":40,"description":41,"timeFrame":42},"Visual Analog Scale","Record pain score with 0 being no pain at all and 10 being worst pain possible.","Once per day from postoperative day 1 to postoperative day 14; at two weeks follow up visit, 6 weeks follow up visit and 12 weeks follow up visit.",{"measure":44,"description":45,"timeFrame":46},"Oral morphine equivalent","Opiate pill count","daily pill count from postoperative day 1 to postoperative day 14; at 2-week follow up visit, 6-week follow up visit and 12-week follow up visit.",[48],{"measure":49,"timeFrame":50},"Incidence of treatment-emergent adverse event.","From day of surgery to 12-week follow up visit.","ALL","14 Years","85 Years",false,{"inclusion":56,"exclusion":64,"raw_text":76},[57,58,59,60,61,62,63],"14-85 years of age.","Patients undergoing primary ACL-R with or without meniscus repair or meniscectomy, with or without chondroplasty.","Patients weigh at least 90lbs at time of enrollment.","Surgery scheduled at a Campbell Clinic Surgery Center (Midtown or Wolf River).","Willing and able to provide written informed consent.","Willing and able to cooperate with postoperative therapy.","Speak and read fluent English.",[65,66,67,68,69,70,71,72,73,74,75],"Multiligament knee reconstruction.","Pre-injury opioid consumption.","Substance abuse disorder (illicit drug abuse, alcoholism, etc).","Concomitant injuries or surgeries warranting pain medication (i.e. polytrauma patient).","Chronic pain syndrome.","Renal disease.","Currently taking selective serotonin reuptake inhibitors and\u002For serotonin and norepinephrine reuptake inhibitors.","Known sensitivity, allergy, or intolerance to medications within protocols.","History of diabetes.","Currently taking glucagon-like peptide 1 agonist.","Female patient who is pregnant on day of surgery or becomes pregnant during study period.","Inclusion Criteria:\n\n* 14-85 years of age.\n* Patients undergoing primary ACL-R with or without meniscus repair or meniscectomy, with or without chondroplasty.\n* Patients weigh at least 90lbs at time of enrollment.\n* Surgery scheduled at a Campbell Clinic Surgery Center (Midtown or Wolf River).\n* Willing and able to provide written informed consent.\n* Willing and able to cooperate with postoperative therapy.\n* Speak and read fluent English.\n\nExclusion Criteria:\n\n* Multiligament knee reconstruction.\n* Pre-injury opioid consumption.\n* Substance abuse disorder (illicit drug abuse, alcoholism, etc).\n* Concomitant injuries or surgeries warranting pain medication (i.e. polytrauma patient).\n* Chronic pain syndrome.\n* Renal disease.\n* Currently taking selective serotonin reuptake inhibitors and\u002For serotonin and norepinephrine reuptake inhibitors.\n* Known sensitivity, allergy, or intolerance to medications within protocols.\n* History of diabetes.\n* Currently taking glucagon-like peptide 1 agonist.\n* Female patient who is pregnant on day of surgery or becomes pregnant during study period.",[78,79,80],"CHILD","ADULT","OLDER_ADULT",[82],{"facility":13,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Memphis","Tennessee","38138","United States",{"lat":88,"lon":89},35.14953,-90.04898,[],[92],{"name":93,"affiliation":13,"role":94},"Joseph Lamplot, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Injury of anterior cruciate ligament",[],{"nct_id":4,"found":54,"summary":15,"prompt_version":15}]