RECRUITING Phase 2 ClinicalTrials.gov

Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

Sponsor: Hartford Hospital • ClinicalTrials.gov ID: NCT07766837

Registry updated: 2026-09-21

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Description

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: Does 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? Researchers will compare standard postoperative care plus tizanidine with standard postoperative care alone to determine whether tizanidine improves postoperative recovery. Participants will: * Be randomly assigned to receive either standard postoperative pain management alone or standard postoperative pain management plus tizanidine for 2 weeks after surgery. * 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. * Allow researchers to review information from their electronic medical record, including healthcare utilization and postoperative outcomes, during the 4-6 weeks following surgery.

Interventions

Tizanidine (Drug)
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/day) for two weeks postoperatively.
Standard-of-Care Therapy (Other)
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.

Eligibility criteria

Inclusion Criteria: * female, age ≥18 and ≤89 years old * any race/ethnicity * English and/or Spanish fluency * undergoing apical suspension: * sacrocolpopexy (laparoscopic or robotic) * uterosacral ligament suspension (vaginal, laparoscopic, or robotic) * sacrospinous ligament fixation * iliococcygeus suspension * surgery being performed at Hartford Hospital Exclusion Criteria: * male * age \<18 or ≥90 years old * pregnant * breastfeeding * documented diagnosis of hypotension in EMR problem list, BP in office or at pre-op PAC (confirmed on repeat) to be systolic \<100 mm Hg and/or diastolic \<70 mm Hg * known intolerance or sensitivity to tizanidine * current use of: * CYP1A2 inhibitor: * clonidine (alpha-2 agonist) antihypertensive * opioid * muscle relaxant * pre-existing * hepatic impairment as defined as transaminitis with ALT or AST \>2x upper limit of normal * diagnoses of cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD) * renal impairment as defined by creatinine clearance \<25 mL/min * obstructive sleep apnea * non-English or non-Spanish speaking * past opioid dependence * concurrent diagnosis of malignancy * concurrent surgery apart from pelvic reconstructive surgery with another specialty * unable/unwilling to consent to participate

Conditions

Post Operative Post Operative Analgesia Urogynecologic Surgery

Locations

Hartford Hospital — Hartford, Connecticut, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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