[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06532708":3,"trial-entities:NCT06532708":111,"trial-summary:NCT06532708":115},{"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":40,"secondary_outcomes":45,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":62,"locations":65,"central_contacts":100,"overall_officials":101,"references":102,"see_also_links":110},"NCT06532708","24-09978-FB","Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery","Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery","UNKNOWN","2024-10-31","2024-07","2024-08-02","2024-07-12","University of Tennessee","OTHER",false,"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.","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.",[19,20],"Opioid Use","Postoperative Pain",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},12,"ESTIMATED",[30,35],{"type":14,"name":31,"description":32,"armGroupLabels":33},"5x Oxycodone Oral Tablets","Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.",[34],"5 Doses",{"type":14,"name":36,"description":37,"armGroupLabels":38},"16x Oxycodone Oral Tablets","Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.",[39],"16 Doses",[41],{"measure":42,"description":43,"timeFrame":44},"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",[46],{"measure":47,"description":48,"timeFrame":49},"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","FEMALE","18 Years","80 Years",true,{"inclusion":55,"exclusion":58,"raw_text":61},[56,57],"Women aged 18 to 80","Undergoing planned laparoscopic hysterectomy as a day surgery procedure",[56,59,60],"Undergoing a non-laparoscopic unplanned surgical procedure","Patients with a history of opioid use disorder or current opioid use disorder","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",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":97},"University of Tennessee Health Science Center","RECRUITING","Memphis","Tennessee","38103","United States",[74,79,83,86,89,91,93,95],{"name":75,"role":76,"phone":77,"email":78},"Amira Wohabrebbi, PhD","CONTACT","901-545-7453","awohabre@uthsc.edu",{"name":80,"role":76,"phone":81,"email":82},"Annette Hickerson, RN","901-448-4784","abpayne@uthsc.edu",{"name":84,"role":85},"John O Schorge, MD","PRINCIPAL_INVESTIGATOR",{"name":87,"role":88},"Emma Ryan, BS","SUB_INVESTIGATOR",{"name":90,"role":88},"Alex Samborski, MD",{"name":92,"role":88},"Caroline Reidy, BS",{"name":94,"role":88},"Rachel Nelson, MD",{"name":96,"role":88},"Daniel Amram, BS",{"lat":98,"lon":99},35.14953,-90.04898,[],[],[103,107],{"pmid":104,"type":105,"citation":106},"36716511","BACKGROUND","Straubhar AM, Stroup C, de Bear O, Dalton L, Rolston A, McCool K, Reynolds RK, McLean K, Siedel JH, Uppal S. Provider compliance with a tailored opioid prescribing calculator in gynecologic surgery. Gynecol Oncol. 2023 Mar;170:229-233. doi: 10.1016\u002Fj.ygyno.2023.01.018. Epub 2023 Jan 28.",{"pmid":108,"type":105,"citation":109},"30837064","Wong M, Vogell A, Wright K, Isaacson K, Loring M, Morris S. Opioid use after laparoscopic hysterectomy: prescriptions, patient use, and a predictive calculator. Am J Obstet Gynecol. 2019 Mar;220(3):259.e1-259.e11. doi: 10.1016\u002Fj.ajog.2018.10.022. Epub 2018 Oct 25.",[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Hysterectomy",[],{"nct_id":4,"found":53,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study that will randomly assign participants to receive either 5 or 16 doses of 5mg oxycodone oral tablets. The study will be single-blinded, meaning you won't know which group you're in, and involves 12 participants.","completed","Opioid Prescribing for Laparoscopic Gynecologic Surgery","This study is looking at how many oxycodone oral tablets are needed for pain relief after laparoscopic hysterectomy (a surgery to remove the uterus through small incisions). Researchers want to see if using a special calculator can help doctors prescribe fewer oxycodone pills compared to standard practice. You could be eligible if you are a woman between 18 and 80 years old and are having a planned laparoscopic hysterectomy. The study aims to find out if using the calculator leads to fewer pills being used by patients. The current status of the study is unclear, and it plans to enroll 12 participants.","You will be followed for two weeks after surgery, with check-ins on day 2, day 7, and a final office visit at two weeks.",102,"You will be contacted on day 2 and day 7 after surgery to ask about your pain level and how many pills you've taken. Two weeks after surgery, you'll have an office visit to discuss pain and return any unused pills.","Not stated in the trial record.",[],"v2"]