[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651941":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":37,"locations":25,"responsibleParty":42,"collaborators":25,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":25,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":25},{"fullName":5,"class":6},"Hartford Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Participants will follow standard-of-care -- the current standard ERAS protocol including preop medication management with Tylenol and Celebrex (unless contraindicated) and postoperative outpatient pain regimen of scheduled Tylenol, Motrin, and as-needed standard amounts of opioid medication. A placebo will not be used in this study.",[13],"Other: Standard-of-Care Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention\u002FTizanidine","EXPERIMENTAL","Participants will follow standard-of-care -- the current standard ERAS protocol above -- and will be given tizanidine 4 mg scheduled three times a day (12 mg\u002Fday) for two weeks postoperatively.",[19],"Drug: Tizanidine",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DRUG","Tizanidine",[15],null,{"type":6,"name":27,"description":11,"armGroupLabels":28,"otherNames":25},"Standard-of-Care Therapy",[9],[30,34],{"name":31,"affiliation":32,"role":33},"Elena Tunitsky, MD","Hartford HealthCare","STUDY_DIRECTOR",{"name":35,"affiliation":32,"role":36},"Sindhura Vallabhaneni, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","(860) 972-4338","Sindhura.Vallabhaneni@hhchealth.org",{"type":43,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100651941","phase-2-postoperative-tizanidine-use-in-pelvic-reconstructive-surgery-a-pilot-study-100651941",false,"NCT07766837","Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study","TIPS","Inclusion Criteria:\n\n* female, age ≥18 and ≤89 years old\n\n  * any race\u002Fethnicity\n  * English and\u002For Spanish fluency\n  * undergoing apical suspension:\n\n    * sacrocolpopexy (laparoscopic or robotic)\n    * uterosacral ligament suspension (vaginal, laparoscopic, or robotic)\n    * sacrospinous ligament fixation\n    * iliococcygeus suspension\n  * surgery being performed at Hartford Hospital\n\nExclusion Criteria:\n\n* male\n\n  * age \\\u003C18 or ≥90 years old\n  * pregnant\n  * breastfeeding\n  * documented diagnosis of hypotension in EMR problem list, BP in office or at pre-op PAC (confirmed on repeat) to be systolic \\\u003C100 mm Hg and\u002For diastolic \\\u003C70 mm Hg\n  * known intolerance or sensitivity to tizanidine\n  * current use of:\n\n    * CYP1A2 inhibitor:\n    * clonidine (alpha-2 agonist) antihypertensive\n    * opioid\n    * muscle relaxant\n  * pre-existing\n\n    * hepatic impairment as defined as transaminitis with ALT or AST \\>2x upper limit of normal\n    * diagnoses of cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD)\n    * renal impairment as defined by creatinine clearance \\\u003C25 mL\u002Fmin\n  * obstructive sleep apnea\n  * non-English or non-Spanish speaking\n  * past opioid dependence\n  * concurrent diagnosis of malignancy\n  * concurrent surgery apart from pelvic reconstructive surgery with another specialty\n  * unable\u002Funwilling to consent to participate","FEMALE","18 Years","89 Years",{"count":55,"type":56},186,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","The goal of this clinical trial is to evaluate whether adding tizanidine to the standard postoperative pain regimen improves recovery after pelvic reconstructive surgery in adult women. The main questions it aims to answer are:\n\nDoes postoperative tizanidine improve patient-reported recovery 4-6 weeks after surgery? Does tizanidine reduce postoperative pain, opioid use, constipation, and healthcare utilization while improving functional recovery?\n\nResearchers will compare standard postoperative care plus tizanidine with standard postoperative care alone to determine whether tizanidine improves postoperative recovery.\n\nParticipants will:\n\n* Be randomly assigned to receive either standard postoperative pain management alone or standard postoperative pain management plus tizanidine for 2 weeks after surgery.\n* Complete electronic surveys before surgery, 1-2 days after surgery, 2 weeks after surgery, and 4-6 weeks after surgery to assess pain, recovery, activity, and bowel function.\n* Allow researchers to review information from their electronic medical record, including healthcare utilization and postoperative outcomes, during the 4-6 weeks following surgery.",[62,63,64],"Post Operative","Post Operative Analgesia","Urogynecologic Surgery",[66,67,68],"post operative","tizanidine","urogynecology","NOT_YET_RECRUITING","2026-08-11",{"date":72,"type":73},"2026-08-17","ACTUAL",{"date":75,"type":56},"2026-07-29",{"date":77,"type":56},"2028-07-29",{"name":5,"class":6}]