[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557022":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":27,"studyPopulation":18,"armGroups":28,"interventions":41,"overallOfficials":18,"centralContacts":18,"locations":50,"responsibleParty":89,"collaborators":18,"id":91,"slug":18,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":18,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":18,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":18,"overallStatus":53,"whyStopped":18,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of Tennessee","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Number of pills used","All participants will be contacted on postoperative days 2 and 7 to inquire how many pills they have taken","Within 1 week following surgery",[14],{"measure":15,"description":16,"timeFrame":17},"Postoperative pain","All participants will be contacted on postoperative days 2 and 7, and at their two-week follow-up visit to inquire where their pain level is on the Visual Analog Scale (VAS). This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.","Within 2 weeks following surgery",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"SINGLE",[26],"PARTICIPANT","The intent of this study is to validate the use of the Opioid Calculator, published at University of Michigan (www.opioidcalculator.org), which takes several variables into account, including age, risk factors (history of depression, alcohol abuse, others) to determine in a more scientific way the number of pills sufficient to prescribe. The sample size was determined by the number of routine post-op laparoscopic patients seen in our practice. The estimated necessary sample size is 6 participants per group (12 total). Patients will be randomized using 3 block groups of size 4 each. Patients will be approached at in clinic at the time they are consenting to laparoscopic hysterectomy and will be counseled about postoperative pain medication management. Randomization to either standard practice or calculator will be performed using computer-generated, permuted blocks of 4 participants. Sealed randomization envelopes will be opened for each subject on the day of surgery, after anesthesia is initiated. The study will be singled-blinded to the participant. Patients will be contacted on day 2 and day 7 to inquire where they are on the Visual Analog Scale (VAS) and how many pills they have taken. Two weeks after surgery patients will be seen in office for VAS and requested to bring unused pills for accounting purposes.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"5 Doses","EXPERIMENTAL","Participants will receive 5 doses of prescription opioids following surgery.",[34],"Other: 5x Oxycodone Oral Tablets",{"label":36,"type":37,"description":38,"interventionNames":39},"16 Doses","ACTIVE_COMPARATOR","Participants will receive 16 doses of prescription opioids following surgery.",[40],"Other: 16x Oxycodone Oral Tablets",[42,46],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":18},"5x Oxycodone Oral Tablets","Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.",[30],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":18},"16x Oxycodone Oral Tablets","Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.",[36],[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"University of Tennessee Health Science Center","RECRUITING","Memphis","Tennessee","38103","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-90.04898,35.14953,{"lat":63,"lon":62},[66,71,75,78,81,83,85,87],{"name":67,"role":68,"phone":69,"phoneExt":18,"email":70},"Amira Wohabrebbi, PhD","CONTACT","901-545-7453","awohabre@uthsc.edu",{"name":72,"role":68,"phone":73,"phoneExt":18,"email":74},"Annette Hickerson, RN","901-448-4784","abpayne@uthsc.edu",{"name":76,"role":77,"phone":18,"phoneExt":18,"email":18},"John O Schorge, MD","PRINCIPAL_INVESTIGATOR",{"name":79,"role":80,"phone":18,"phoneExt":18,"email":18},"Emma Ryan, BS","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":18,"phoneExt":18,"email":18},"Alex Samborski, MD",{"name":84,"role":80,"phone":18,"phoneExt":18,"email":18},"Caroline Reidy, BS",{"name":86,"role":80,"phone":18,"phoneExt":18,"email":18},"Rachel Nelson, MD",{"name":88,"role":80,"phone":18,"phoneExt":18,"email":18},"Daniel Amram, BS",{"type":90,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100557022",false,"NCT06532708","Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery","Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery","Inclusion Criteria:\n\n* Women aged 18 to 80\n* Undergoing planned laparoscopic hysterectomy as a day surgery procedure\n\nExclusion Criteria:\n\n* Women aged 18 to 80\n* Undergoing a non-laparoscopic unplanned surgical procedure\n* Patients with a history of opioid use disorder or current opioid use disorder",true,"FEMALE","18 Years","80 Years",{"count":102,"type":103},12,"ESTIMATED","INTERVENTIONAL",[106],"NA","The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices, or with the use of a calculator, i.e., the Opioid Calculator, published by the University of Michigan (www.opioidcalculator.org), with the intent of decreasing the number of pills.",[109,110],"Opioid Use","Postoperative Pain","2024-07-31",{"date":113,"type":114},"2024-08-02","ACTUAL",{"date":116,"type":114},"2024-07-12",{"date":118,"type":103},"2024-10-31",{"name":5,"class":6},1]