[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06338865":3,"trial-entities:NCT06338865":140,"trial-summary:NCT06338865":144},{"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":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":54,"secondary_outcomes":59,"sex":94,"minimum_age":95,"maximum_age":96,"healthy_volunteers":15,"eligibility_criteria":97,"std_ages":111,"locations":114,"central_contacts":129,"overall_officials":134,"references":138,"see_also_links":139},"NCT06338865","Study00003146","Short Title: Standard vs. Lower Pressure Pneumoperitoneum","Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial","RECRUITING","2027-04","2024-05","2024-05-10","2024-05-03","Cedars-Sinai Medical Center","OTHER",false,"This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.","This will be a single-center, single-blinded randomized controlled trial evaluating the impact of lower pressure pneumoperitoneum on post-operative pain and surgical field visualization among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that lower insufflation pressures will decrease post-operative pain in the immediate post-operative period without compromising surgical field visualization. The study will include 3 groups corresponding to varying insufflation pressures: 15mmHg (standard), 12mmHg and 10mmHg. Participants will be 1:1:1 allocated to the 15mmHg, 12mmHg or 10mmHg groups (parallel design) by block randomization.\n\nGiven inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery, the investigators will be enrolling patients in two separate arms depending on their planned procedure:\n\n1. Standard vs. Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery\n2. Standard vs. Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery.\n\nThe methodology for the two arms will be otherwise identical.",[19],"Laparoscopic Surgery",[21,22,23,24,25,26],"laparoscopic surgery","insufflation","pneumoperitoneum","gynecologic surgery","postoperative pain","robotic surgery","INTERVENTIONAL","PREVENTION",[30],"NA",{"count":32,"type":33},294,"ESTIMATED",[35,45,50],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Carbon dioxide","Gas used for insufflation pressure",[39,40,41,42,43,44],"10mmHg (Conventional Laparoscopic Arm)","10mmHg (Robotic-Assisted Laparoscopic Arm)","12mmHg (Conventional Laparoscopic Arm)","12mmHg (Robotic-Assisted Laparoscopic Arm)","15mmHg (Conventional Laparoscopic Arm)","15mmHg (Robotic-Assisted Laparoscopic Arm)",{"type":46,"name":47,"description":48,"armGroupLabels":49},"DRUG","Bupivacaine","Local subcutaneous infiltration of all port sites with 0.25% bupivacaine will be performed prior to each incision. Remaining local anesthetic will be administered into the incision sites prior to the conclusion of the case (30cc total).",[39,40,41,42,43,44],{"type":46,"name":51,"description":52,"armGroupLabels":53},"Oxycodone","All patients will be prescribed a total of 10 pills of oxycodone 5mg, which is the standard amount that our practice prescribes for patients after laparoscopic surgery.",[39,40,41,42,43,44],[55],{"measure":56,"description":57,"timeFrame":58},"Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)","The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning \"no pain\" and 10 meaning \"the worst pain imaginable.\"","Postoperatively, before discharge from PACU (postoperative day 0)",[60,63,66,70,73,76,78,80,82,84,87,91],{"measure":61,"description":57,"timeFrame":62},"First reported pain score in PACU (numerical rating scale, 0-10)","Immediately upon arrival to PACU (postoperative day 0)",{"measure":64,"description":57,"timeFrame":65},"Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)","Immediately prior to discharge from PACU (postoperative day 0)",{"measure":67,"description":68,"timeFrame":69},"Inpatient morphine milligram equivalents","Daily total of opioid medications administered on the day of surgery","Day of surgery (postoperative day 0)",{"measure":71,"timeFrame":72},"Total number of 5mg oxycodone pills taken in the 2 weeks following discharge","Assessed at postoperative day 14",{"measure":74,"timeFrame":75},"Need for insufflation pressure increase intra-operatively due to inadequate visualization","Intraoperative",{"measure":77,"timeFrame":75},"Operative time",{"measure":79,"timeFrame":75},"Estimated blood loss",{"measure":81,"timeFrame":75},"Intraoperative complications",{"measure":83,"timeFrame":75},"Conversion to laparotomy",{"measure":85,"description":86,"timeFrame":58},"Postoperative length of stay","From arrival to PACU to discharge home",{"measure":88,"description":89,"timeFrame":90},"Surgeon-reported adequacy of assigned insufflation pressure","Surgeons will rate their agreement with the following statement on a 5-point Likert scale (from strongly disagree to strongly agree): \"The assigned insufflation pressure was adequate for this procedure\"","Immediately following surgery",{"measure":92,"description":93,"timeFrame":75},"Need for adjustment of insufflation pressure","In a post-op questionnaire, surgeons will indicate whether the insufflation pressure was adjusted at any point during the procedure (yes\u002Fno).","FEMALE","18 Years",null,{"inclusion":98,"exclusion":103,"raw_text":110},[99,100,101,102],"Provision of signed and dated informed consent form","Stated willingness to comply with all study procedures and availability for the duration of the study","18 years of age or older","Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.",[104,105,106,107,108,109],"Pregnancy","Urgent\u002Fnon-scheduled surgery","Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)","Baseline opioid use","Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen","Planned post-operative admission","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* 18 years of age or older\n* Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.\n\nExclusion Criteria:\n\n* Pregnancy\n* Urgent\u002Fnon-scheduled surgery\n* Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)\n* Baseline opioid use\n* Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen\n* Planned post-operative admission",[112,113],"ADULT","OLDER_ADULT",[115],{"facility":13,"status":8,"city":116,"state":117,"zip":118,"country":119,"contacts":120,"geoPoint":126},"Los Angeles","California","90048","United States",[121],{"name":122,"role":123,"phone":124,"email":125},"Rebecca Schneyer, MD","CONTACT","914-391-2604","rebecca.schneyer@cshs.org",{"lat":127,"lon":128},34.05223,-118.24368,[130,131],{"name":122,"role":123,"phone":124,"email":125},{"name":132,"role":123,"email":133},"Rebekah Odum, BSN","rebekah.odum@cshs.org",[135],{"name":136,"affiliation":13,"role":137},"Matthew Siedhoff, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":141,"biomarkers":143},[142,19],"Gynecological Surgical Procedure",[],{"nct_id":4,"found":145,"summary":146,"prompt_version":156},true,{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is a single-center, single-blinded randomized controlled trial with 294 planned participants. Participants will be randomly assigned to one of three groups (15mmHg, 12mmHg, or 10mmHg pressure) for their laparoscopic surgery.","completed","Laparoscopic Surgery Pain Study: Standard vs. Lower Pressure Pneumoperitoneum","This study is looking at how different levels of gas pressure during laparoscopic surgery (a type of minimally invasive surgery) affect pain after the operation. Researchers are comparing standard pressure (15mmHg) with lower pressures (12mmHg and 10mmHg) to see if lower pressure can reduce pain without making it harder for the surgeon to see. All patients will receive bupivacaine (a local anesthetic) at the incision sites and oxycodone (a pain medication) after surgery. The main goal is to measure your maximum pain score in the recovery room. You may be able to join if you are 18 or older, female, and having laparoscopic gynecologic surgery at Cedars-Sinai Medical Center. The current status of this study is unclear.","Your pain will be measured before discharge from the post-anesthesia care unit (PACU) on postoperative day 0.",117,"You would need to provide signed consent and be available for the duration of the study. The study involves undergoing laparoscopic surgery with specific insufflation pressures and having your pain measured after the procedure.","Not stated in the trial record.",[47,51],"v2"]