[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07400146":3,"trial-entities:NCT07400146":182,"trial-summary:NCT07400146":186},{"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":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":77,"minimum_age":78,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":79,"std_ages":96,"locations":99,"central_contacts":120,"overall_officials":124,"references":125,"see_also_links":181},"NCT07400146","STUDY00003947","Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy","Instillation of Bupivacaine With Epinephrine Over Diaphragm to Reduce Postoperative Shoulder Pain Following Benign Gynecologic Laparoscopic Surgery: A Randomized Control Trial","NOT_YET_RECRUITING","2026-08","2026-02","2026-02-10","Cedars-Sinai Medical Center","OTHER",true,"Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to subcutaneous tissue for general postoperative pain management after surgery is well established. However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery. The purpose of the study is to evaluate if sprayed infra-diaphragmatic bupivacaine compared to placebo (saline) will improve postoperative shoulder pain in patients undergoing benign laparoscopic gynecologic surgery. The entire study will be conducted at Cedar Sinai Medical Center.",null,[18,19],"Postoperative Pain","Shoulder Pain",[21,22,23],"Laparoscopy","Gynecologic surgery","Bupivacaine","INTERVENTIONAL","PREVENTION",[27],"PHASE4",{"count":29,"type":30},100,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Instillation of Bupivacaine with epinephrine over the diaphragm","Prior to desufflation of the abdomen during the laparoscopic gynecologic procedure, the surgeon will instill 30mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) laparoscopically aiming to cover the diaphragm with liquid.",[37],"Bupivacaine with epinephrine",[39],{"measure":40,"description":41,"timeFrame":42},"Post-operative shoulder pain scores","Reported right shoulder pain score using visual analog score (VAS) 24 hours postoperatively Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group\n\nAssessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis","24 hours postoperatively",[44,48,51,54,58,62,66,69,73],{"measure":45,"description":46,"timeFrame":47},"Post-operative generalized pain scores","Post-operative generalized pain scores (superiority):\n\nNull hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= pain scores will be lower among the bupivacaine with epinephrine group\n\nFirst and last reported generalized pain score in post-anaesthesia care unit (PACU) using numerical rating score Assessed using the validated 11-point numerical rating scale (0-10), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis","up to 6 hours in post-anaesthesia care unit (PACU)",{"measure":49,"description":50,"timeFrame":47},"Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents","Calculated in morphine milligram equivalents (continuous data) Analyzed using the Kruskall-Wallis test (assuming non-normal data) Data will be presented as median (range)",{"measure":52,"description":53,"timeFrame":47},"Length of stay in post-anaesthesia care unit (PACU)","Length of stay in post-anaesthesia care unit (PACU) (superiority):\n\nNull hypothesis = PACU length of stay will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= PACU length of stay will be shorter in the bupivacaine with epinephrine groups\n\nDocumented in minutes (continuous data) Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed",{"measure":55,"description":56,"timeFrame":57},"Post-operative shoulder pain scores at home","Daily reported post-operative shoulder pain scores at home (superiority):\n\nNull hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group\n\nAssessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis","5 days postoperatively",{"measure":59,"description":60,"timeFrame":61},"Post-operative opioid use","Post-operative opioid use (superiority):\n\nNull hypothesis = post-op opioid use will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= post-op opioid use will be lower among the bupivacaine with epinephrine group\n\nNumber of pills used reported by patient (interval data) Analyzed using the Kruskall-Wallis test Data will be presented as median (range)","1 week postoperative",{"measure":63,"description":64,"timeFrame":65},"Surgical outcome: EBL","Surgical outcomes: EBL (mL) Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group\n\nContinuous variables: estimated blood loss Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed","up to 8 hours",{"measure":67,"description":68,"timeFrame":65},"Surgical outcome: operative time","Surgical outcomes: operative time (minutes) Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group\n\nContinuous variables: operative time, estimated blood loss Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed",{"measure":70,"description":71,"timeFrame":72},"Surgical outcome: intraoperative complications","Surgical outcomes: intraoperative complications Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group\n\nBinary data: Surgical complications (yes\u002Fno) Analyzed using chi-square test","within 1 week of surgery",{"measure":74,"description":75,"timeFrame":76},"Surgical outcomes: conversion to laparotomy","Surgical outcomes: conversion to laparotomy Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group\n\nBinary data: conversion to laparotomy (yes\u002Fno) Analyzed using chi-square test","within 6 hours of surgery start time","FEMALE","18 Years",{"inclusion":80,"exclusion":85,"raw_text":95},[81,82,83,84],"Provide a signed and dated informed consent form","Stated willingness to comply with all study procedures and availability for the duration of the study","8 years of age or older","Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.",[86,87,88,89,90,91,92,93,94],"Pregnancy","Urgent\u002Fnon-scheduled surgery","Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)","Baseline shoulder pain","Baseline opioid use","Baseline of chronic pain syndrome","Conversion to open surgery","Allergy or intolerance to bupivacaine, lidocaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen","Planned post-operative admission","Inclusion Criteria:\n\n* Provide a signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* 8 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 shoulder pain\n* Baseline opioid use\n* Baseline of chronic pain syndrome\n* Conversion to open surgery\n* Allergy or intolerance to bupivacaine, lidocaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen\n* Planned post-operative admission",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":117},"Cedars Sinai Medical Center","Los Angeles","California","90048","United States",[107,112,114],{"name":108,"role":109,"phone":110,"email":111},"Ogechukwu Ezike, MD","CONTACT","3473371181","ogechukwu.ezike@cshs.org",{"name":108,"role":113},"SUB_INVESTIGATOR",{"name":115,"role":116},"Kelly Wright, MD","PRINCIPAL_INVESTIGATOR",{"lat":118,"lon":119},34.05223,-118.24368,[121,122],{"name":108,"role":109,"phone":110,"email":111},{"name":115,"role":109,"email":123},"kelly.wright@cshs.org",[],[126,130,133,136,139,142,145,148,151,154,157,160,163,166,169,172,175,178],{"pmid":127,"type":128,"citation":129},"25724402","BACKGROUND","Hammer A, Rositch AF, Kahlert J, Gravitt PE, Blaakaer J, Sogaard M. Global epidemiology of hysterectomy: possible impact on gynecological cancer rates. Am J Obstet Gynecol. 2015 Jul;213(1):23-29. doi: 10.1016\u002Fj.ajog.2015.02.019. Epub 2015 Feb 25.",{"pmid":131,"type":128,"citation":132},"23084671","Alperin M, Kivnick S, Poon KY. Outpatient laparoscopic hysterectomy for large uteri. J Minim Invasive Gynecol. 2012 Nov-Dec;19(6):689-94. doi: 10.1016\u002Fj.jmig.2012.06.007.",{"pmid":134,"type":128,"citation":135},"25655043","Driessen SR, Baden NL, van Zwet EW, Twijnstra AR, Jansen FW. Trends in the implementation of advanced minimally invasive gynecologic surgical procedures in the Netherlands. J Minim Invasive Gynecol. 2015 May-Jun;22(4):642-7. doi: 10.1016\u002Fj.jmig.2015.01.026. Epub 2015 Feb 3.",{"pmid":137,"type":128,"citation":138},"16625589","Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003677. doi: 10.1002\u002F14651858.CD003677.pub3.",{"pmid":140,"type":128,"citation":141},"25884671","Jaschinski T, Mosch C, Eikermann M, Neugebauer EA. Laparoscopic versus open appendectomy in patients with suspected appendicitis: a systematic review of meta-analyses of randomised controlled trials. BMC Gastroenterol. 2015 Apr 15;15:48. doi: 10.1186\u002Fs12876-015-0277-3.",{"pmid":143,"type":128,"citation":144},"30914471","Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136\u002Frapm-2018-100024. Epub 2019 Feb 3.",{"pmid":146,"type":128,"citation":147},"20351978","Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010 Mar;83(1):11-25.",{"pmid":149,"type":128,"citation":150},"22227789","American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097\u002FALN.0b013e31823c1030. No abstract available.",{"pmid":152,"type":128,"citation":153},"35973919","Bougie O, Blom J, Zhou G, Murji A, Thurston J. Use and misuse of opioid after gynecologic surgery. Best Pract Res Clin Obstet Gynaecol. 2022 Dec;85(Pt B):23-34. doi: 10.1016\u002Fj.bpobgyn.2022.07.005. Epub 2022 Jul 18.",{"pmid":155,"type":128,"citation":156},"28043841","Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016\u002Fj.ajog.2016.12.175. Epub 2016 Dec 30.",{"pmid":158,"type":128,"citation":159},"33706344","Clark NV, Moore K, Maghsoudlou P, North A, Ajao MO, Einarsson JI, Louie M, Schiff L, Moawad G, Cohen SL, Carey ET. Superior Hypogastric Plexus Block to Reduce Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2021 Apr 1;137(4):648-656. doi: 10.1097\u002FAOG.0000000000004329.",{"pmid":161,"type":128,"citation":162},"37004537","Miao L, Chen Q, Wang Y, Wang D, Zhou M. Effect of intraperitoneal infusion of ropivacaine combined with dexmedetomidine in patients undergoing total laparoscopic hysterectomy: a single-center randomized double-blinded controlled trial. Arch Gynecol Obstet. 2024 Apr;309(4):1387-1393. doi: 10.1007\u002Fs00404-023-07020-w. Epub 2023 Apr 1.",{"pmid":164,"type":128,"citation":165},"27984226","Patel R, Carvalho JC, Downey K, Kanczuk M, Bernstein P, Siddiqui N. Intraperitoneal Instillation of Lidocaine Improves Postoperative Analgesia at Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2017 Feb;124(2):554-559. doi: 10.1213\u002FANE.0000000000001799.",{"pmid":167,"type":128,"citation":168},"32206659","Cho M, Kim CJ, Hahm TS, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS, Choi CH. Combination of a pulmonary recruitment maneuver and intraperitoneal bupivacaine for the reduction of postoperative shoulder pain in gynecologic laparoscopy: a randomized, controlled trial. Obstet Gynecol Sci. 2020 Mar;63(2):187-194. doi: 10.5468\u002Fogs.2020.63.2.187. Epub 2020 Feb 20.",{"pmid":170,"type":128,"citation":171},"23745303","Sutchritpongsa P, Chaipakdi P, Sirimai K, Chalermchokcharoenkit A, Tanmahasamut P. Intraperitoneal sub-diaphragmatic instillation of bupivacaine plus morphine for reducing postoperative shoulder pain after gynecologic endoscopy. J Med Assoc Thai. 2013 May;96(5):513-8.",{"pmid":173,"type":128,"citation":174},"23925646","Roy KK, Subbaiah M, Naha M, Kumar S, Sharma JB, Jahagirdar N. Intraperitoneal bupivacaine for pain relief after minilaparoscopy in patients with infertility. Arch Gynecol Obstet. 2014 Feb;289(2):337-40. doi: 10.1007\u002Fs00404-013-2994-6. Epub 2013 Aug 8.",{"pmid":176,"type":128,"citation":177},"27007272","Ruiz-Tovar J, Gonzalez J, Garcia A, Cruz C, Rivas S, Jimenez M, Ferrigni C, Duran M. Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery: a Prospective Randomized Clinical Trial. Obes Surg. 2016 Nov;26(11):2616-2621. doi: 10.1007\u002Fs11695-016-2142-z.",{"pmid":179,"type":128,"citation":180},"28669869","Yong L, Guang B. Intraperitoneal ropivacaine instillation versus no intraperitoneal ropivacaine instillation for laparoscopic cholecystectomy: A systematic review and meta-analysis. Int J Surg. 2017 Aug;44:229-243. doi: 10.1016\u002Fj.ijsu.2017.06.043. Epub 2017 Jun 30.",[],{"nct_id":4,"conditions":183,"biomarkers":185},[184],"Gynecological Surgical Procedure",[],{"nct_id":4,"found":14,"summary":187,"prompt_version":197},{"design":188,"status":189,"heading":190,"summary":191,"follow_up":192,"word_count":193,"commitments":194,"compensation":195,"drugs_mentioned":196},"This interventional study plans to enroll 100 women to compare bupivacaine with epinephrine to a placebo (saline).","completed","Bupivacaine with Epinephrine for Shoulder Pain After Laparoscopy","This study is investigating if applying bupivacaine with epinephrine to the diaphragm during laparoscopic gynecologic surgery can reduce shoulder pain after the procedure. Bupivacaine is a local anesthetic (numbing medicine). While local anesthetics are known to help with general pain after surgery, this study is the first to look at spraying bupivacaine over the diaphragm to specifically target shoulder pain. Researchers will compare bupivacaine with epinephrine to a placebo (saline solution). The main goal is to see if participants who receive bupivacaine with epinephrine have lower shoulder pain scores 24 hours after surgery. You may be able to join if you are a woman aged 18 or older, undergoing laparoscopic gynecologic surgery at Cedars-Sinai Medical Center, and willing to follow all study procedures. The study is currently recruiting 100 participants.","Your postoperative shoulder pain scores will be measured at 24 hours after surgery.",130,"You would undergo laparoscopic gynecologic surgery at Cedars-Sinai Medical Center and your postoperative shoulder pain scores would be measured 24 hours after surgery.","Not stated in the trial record.",[],"v2"]