[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03825809":3,"trial-entities:NCT03825809":106,"trial-summary:NCT03825809":111},{"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":26,"interventions":29,"primary_outcomes":64,"secondary_outcomes":72,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":81,"locations":84,"central_contacts":97,"overall_officials":101,"references":104,"see_also_links":105},"NCT03825809","1231914","Nonopioid Analgesia After Labral Surgery","Traditional vs. Nonopioid Analgesia After Labral Surgery","RECRUITING","2020-05-20","2019-01","2019-01-31","2019-01-22","Henry Ford Health System","OTHER",true,"This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen","Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.\n\nPatients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia\n\nPrimary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.\n\nStatistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.",[19],"Narcotic Use",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE2","PHASE3",{"count":27,"type":28},100,"ESTIMATED",[30,37,44,49,54,59],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Celecoxib","Post-Operative Non Opioid Pain Protocol",[33],[36],"Celebrex",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"Hydrocodone-Acetaminophen","Traditionally used narcotic pain protocol",[41],"Post-Operative Traditional Pain Protocol",[43],"Norco",{"type":31,"name":45,"description":33,"armGroupLabels":46,"otherNames":47},"Ketorolac",[33],[48],"Toradol",{"type":31,"name":50,"description":33,"armGroupLabels":51,"otherNames":52},"Gabapentin",[33],[53],"Neurontin",{"type":31,"name":55,"description":33,"armGroupLabels":56,"otherNames":57},"Acetaminophen",[33],[58],"Tylenol",{"type":31,"name":60,"description":33,"armGroupLabels":61,"otherNames":62},"Diazepam",[33],[63],"Valium",[65,69],{"measure":66,"description":67,"timeFrame":68},"Pain Levels","Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.","10 days post-operatively",{"measure":70,"description":71,"timeFrame":68},"Patient-Reported Outcomes Measurement Information System","Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.",[],"ALL","18 Years",null,{"inclusion":77,"exclusion":79,"raw_text":80},[78],"All adult patients over age 18 and scheduled for a primary or revision labral surgery",[],"Eligibility Criteria:\n\nInclusion Criteria:\n\n* All adult patients over age 18 and scheduled for a primary or revision labral surgery\n\nExclusion Criteria:\n\n* Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":94},"Detroit","Michigan","48202","United States",[91],{"name":92,"role":93},"Toufic R Jildeh, MD","CONTACT",{"lat":95,"lon":96},42.33143,-83.04575,[98],{"name":92,"role":93,"phone":99,"email":100},"517-230-8511","tjildeh1@hfhs.org",[102],{"name":92,"affiliation":13,"role":103},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":110},[108,109],"Labial tear","Rupture of rotator cuff of shoulder",[],{"nct_id":4,"found":15,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is a randomized, single-blinded study comparing two treatment groups. About 100 participants will be enrolled.","completed","Nonopioid Pain Control After Labral Surgery","This study is comparing two ways to manage pain after labral surgery (surgery on the shoulder or hip joint). One group will receive a non-opioid pain regimen, which includes medications like Celecoxib, Ketorolac, Gabapentin, and Acetaminophen. The other group will receive the traditional pain control, which includes Hydrocodone-Acetaminophen (a narcotic). Researchers want to see if the non-opioid approach can reduce pain as effectively. You may be able to join if you are an adult over 18 and are scheduled for labral surgery. The study will measure your pain levels and how you feel about your recovery 10 days after surgery. The study aims to enroll 100 participants.","Your pain levels and patient-reported outcomes will be measured for 10 days post-operatively.",107,"You will be assigned to one of two pain management groups. Your pain levels and recovery will be tracked daily using a journal and at your first post-operative appointment, which is within one week of surgery.","Not stated in the trial record.",[32,38,45,50,55],"v2"]