[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580858":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":30,"locations":36,"responsibleParty":50,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":24,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":24,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":76,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Tennessee","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal saline intraperitoneal wash post procedure","ACTIVE_COMPARATOR","The control group (standard care) will receive an intraperitoneal wash with a fixed amount of saline.",[13],"Other: Normal Saline (0.9% NaCl)",{"label":15,"type":10,"description":16,"interventionNames":17},"Marcaine hydrochloride without epinephrine 0.5% intraperitoneal wash","The experimental group (comparison treatment) will receive an intraperitoneal wash with 20 mL of Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% at the end of surgery.",[18],"Drug: Marcaine hydrochloride without epinephrine 0.5%",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Normal Saline (0.9% NaCl)","Women will undergo planned, laparoscopic gynecologic surgery with an intraperitoneal wash of 20 mL of saline (standard) at the end of the operation, prior to insufflation, release, and skin closure.\n\nThe wash will be instilled into the peritoneal cavity and the surgical area (over the vaginal cuff and along the bilateral pelvic sidewalls to the paracolic gutters).\n\nAll participants will rate their pain using a Visual Analogue Scale (VAS). The VAS is a numerical rating system where the scores range from zero (0) to ten (10), with zero indicating 'no pain at all' and ten indicating 'the worst possible pain'.\n\nParticipants will be asked to rate their current level of pain and also report their current dosage of pain medication at the following intervals: pre-operatively, 2 hours post-operatively, and 24 hours post-operatively.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DRUG","Marcaine hydrochloride without epinephrine 0.5%","Women will undergo planned, laparoscopic gynecologic surgery with an intraperitoneal wash of 20 mL Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% (the comparator) at the end of the operation, prior to insufflation, release, and skin closure. The wash will be instilled into the peritoneal cavity and the surgical area (over the vaginal cuff and along the bilateral pelvic sidewalls to the paracolic gutters). All participants will rate their pain using a Visual Analogue Scale (VAS). The VAS is a numerical rating system where the scores range from zero (0) to ten (10), with zero indicating 'no pain at all' and ten indicating 'the worst possible pain'. Participants will be asked to rate their current level of pain and also report their current dosage of pain medication at the following intervals: pre-operatively, 2 hours post-operatively, and 24 hours post-operatively.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"John O. Schorge, MD","CONTACT","901-448-2531","jschorge@uthsc.edu",[37],{"facility":38,"status":24,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":24},"University of Tennessee Health Science Center","Memphis","Tennessee","38163","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-90.04898,35.14953,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","John Schorge,MD","OB\u002FGYN Chair and Professor","100580858","phase-4-pain-with-differing-intraperitoneal-washes-at-the-end-of-laparoscopic-gynecologic-surgery-100580858",false,"NCT06842771","Pain with Differing Intraperitoneal Washes At the End of Laparoscopic Gynecologic Surgery","Inclusion Criteria:\n\n* Age 18 years and older\n* Undergoing planned laparoscopic adnexal surgery as a day surgery procedure; The surgical site is the \"adnexa\" which contains the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue. The \"adnexa\" does not include the uterus.\n* BMI 55.0 or less\n\nExclusion Criteria:\n\n* Under age 18\n* Undergoing a non-laparoscopic unplanned surgical procedure Patients having a laparoscopic partial or complete removal of the uterus, a hysterectomy, will NOT be included in this study population for enrollment.\n* septicemia\n* severe hemorrhage\n* severe hypotension or shock\n* arrhythmias\n* known hypersensitivity to bupivacaine or to any other local anesthetic agent\n* local infection at the injection site","FEMALE","18 Years",{"count":63,"type":64},96,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","We hypothesize that instilling intraperitoneal Marcaine (without epinephrine) at the end of a non-total laparoscopic gynecologic surgery (adnexa only, which includes the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue) will result in less pain and reduced opioid use postoperatively.",[70],"Laparoscopic Adnexal Surgery",[72,73,74,75],"laparoscopic gynecologic surgery","adnexal laparoscopic surgery","ovarian laparoscopic surgery","fallopian tube laparoscopic surgery","NOT_YET_RECRUITING","2025-02-18",{"date":79,"type":80},"2025-02-24","ACTUAL",{"date":82,"type":64},"2025-03",{"date":84,"type":64},"2027-03",{"name":5,"class":6},1]