[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555186":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":39,"studyPopulation":30,"armGroups":40,"interventions":53,"overallOfficials":30,"centralContacts":30,"locations":63,"responsibleParty":102,"collaborators":30,"id":104,"slug":30,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":30,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":30,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":30,"overallStatus":66,"whyStopped":30,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of Tennessee","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Pain on postoperative day 1","All participants will be asked to rate their pain using the Visual Analog Scale (VAS) approximately 24 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.","24 hours following surgery",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Preoperative pain","All participants will be asked to rate their pain using the Visual Analog Scale (VAS) upon their arrival before surgery. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.","Within 2 hours before surgery",{"measure":19,"description":20,"timeFrame":21},"Postoperative pain while in PACU","All participants will be asked to rate their pain using the Visual Analog Scale (VAS) while they are recovering in PACU, approximately 2 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.","Approximately 2 hours after surgery completion",{"measure":23,"description":24,"timeFrame":25},"Postoperative pain at follow-up visit","All participants will be asked to rate their pain using the Visual Analog Scale (VAS) at their 2-week postoperative follow-up visit. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.","Approximately 2 weeks after surgery completion",{"measure":27,"description":28,"timeFrame":29},"Opioid use after discharge","All participants will be asked about the number of prescription opioid pills they took following discharge.","Within 2 weeks after surgery",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"SINGLE",[38],"PARTICIPANT","This is a prospective, single-blinded, randomized clinical trial in which participants undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to undergo surgery with peritoneal insufflation pressure set to 15 mmHg (standard) or 12 mmHg (comparison). Randomization was performed using computer-generated permuted blocks of four participants. All participants on the first postoperative day will be asked to rate their pain with a Visual Analog Scale (VAS). At a postoperative visit 2 weeks after surgery, all participants will be asked to complete the VAS again. The highest preoperative pain (up to 2 hours before surgery) and immediate postoperative pain, using the VAS, in the post anesthesia care unit (PACU) will be recorded. All participants will be planned for discharge from PACU. Age, body mass index, gynecologic diagnosis, medical history, and preoperative analgesia or opioid use will be extracted from the medical records by trained research staff and entered into a secure electronic database. Preoperative analgesia and opioid saw will be verified with active prescription records at the time of surgery. After surgery, analgesic doses, operative time, additional procedures performed, conversion to laparotomy or increased insufflation pressure, estimated blood loss, and length of stay will be recorded.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"12 mmHg Insufflation Pressure","EXPERIMENTAL","Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy.",[46],"Procedure: Lower Insufflation Pressure",{"label":48,"type":49,"description":50,"interventionNames":51},"15 mmHg Insufflation Pressure","ACTIVE_COMPARATOR","Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy.",[52],"Procedure: Standard Insufflation Pressure",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":30},"PROCEDURE","Lower Insufflation Pressure","Participants underwent laparoscopic hysterectomy with an insufflation pressure that is lower than the standard insufflation pressure used in this type of surgery.",[42],{"type":55,"name":60,"description":61,"armGroupLabels":62,"otherNames":30},"Standard Insufflation Pressure","Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.",[48],[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"University of Tennessee Health Science Center","RECRUITING","Memphis","Tennessee","38103","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-90.04898,35.14953,{"lat":76,"lon":75},[79,84,88,91,94,96,98,100],{"name":80,"role":81,"phone":82,"phoneExt":30,"email":83},"Amira Wohabrebbi, PhD","CONTACT","901-545-7453","awohabre@uthsc.edu",{"name":85,"role":81,"phone":86,"phoneExt":30,"email":87},"Annette Hickerson, RN","901-448-4784","abpayne@uthsc.edu",{"name":89,"role":90,"phone":30,"phoneExt":30,"email":30},"John O Schorge, MD","PRINCIPAL_INVESTIGATOR",{"name":92,"role":93,"phone":30,"phoneExt":30,"email":30},"Emma Ryan, BS","SUB_INVESTIGATOR",{"name":95,"role":93,"phone":30,"phoneExt":30,"email":30},"Alex Samborski, MD",{"name":97,"role":93,"phone":30,"phoneExt":30,"email":30},"Daniel Amran, BS",{"name":99,"role":93,"phone":30,"phoneExt":30,"email":30},"Jenny Stapel, MD",{"name":101,"role":93,"phone":30,"phoneExt":30,"email":30},"Riley Short, MD",{"type":103,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100555186",false,"NCT06508814","Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy","Inclusion Criteria:\n\n* Women aged 18 to 80\n* BMI 55.0 or less\n* Laparoscopic hysterectomy surgery planned\n\nExclusion Criteria:\n\n* Women younger than 18 or older than 80 years of age\n* BMI over 55.0\n* Laparoscopic hysterectomy surgery not planned",true,"FEMALE","18 Years","80 Years",{"count":114,"type":115},100,"ESTIMATED","INTERVENTIONAL",[118],"NA","The purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy.",[121],"Post Operative Pain","2024-07-19",{"date":124,"type":125},"2024-07-23","ACTUAL",{"date":127,"type":125},"2024-06-10",{"date":129,"type":115},"2025-06-10",{"name":5,"class":6},1]