Recruiting
Phase 2

Tizanidine

Sponsor:

Hartford Hospital

Code:

NCT07766837

Conditions

Post Operative

Post Operative Analgesia

Urogynecologic Surgery

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tizanidine

Standard-of-Care Therapy

Study Details

Brief summary:

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.

Conditions

Post Operative

Post Operative Analgesia

Urogynecologic Surgery

Study ID

NCT07766837

Start date

Aug 21, 2026

Status verified date

Sep, 2026

Completion date

Jul 29, 2028

Anticipated

Primary completion date

Jul 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

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.

experimental: Intervention/Tizanidine

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.

Interventions

Tizanidine

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

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.

Primary outcome measure

  • Patient Reported Outcome (PRO) [ Time Frame: 4-6 weeks post-operatively ]

Central Contacts and Locations

Central contacts

Sindhura Vallabhaneni, MD

(860) 972-4338Sindhura.Vallabhaneni@hhchealth.org

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06103

Contacts

Sindhura Vallabhaneni, MD

860-972-8338sindhura.vallabhaneni@hhchealth.org

More Information

Sponsor

Hartford Hospital

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • post operative
  • tizanidine
  • urogynecology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.