Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study (TIPS)

August 11, 2026 updated by: Hartford Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This pilot study evaluates the effectiveness of postoperative tizanidine as an adjunct to existing postoperative pain regimens for patients undergoing pelvic reconstructive surgery. Enhanced Recovery After Surgery (ERAS) pathways in gynecologic surgery have been associated with decreased postoperative pain, need for analgesia, complications, re-admissions, and length of hospital stay, with an emphasis on multimodal regimens and minimizing opioid administration. However, postoperative pain after urogynecologic surgery remains multifactorial and may be related to pelvic floor muscle spasm or dysfunction following surgery. Tizanidine, a skeletal muscle relaxant that acts centrally as an alpha-2 adrenergic agonist, has the unique ability to address pelvic floor muscle spasm and its contribution to postoperative pain, while having fewer adverse events in older patients compared to other skeletal muscle relaxants. Although one randomized control trial demonstrated favorable effects of tizanidine on postoperative pain and recovery after inguinal hernia repair, no previous studies have examined its role in postoperative recovery and pain control for gynecologic patients.

The study will be conducted as a prospective, longitudinal, non-blinded, two-arm randomized controlled trial comparing the postoperative experience and pain control of patients utilizing tizanidine to those who are not taking tizanidine. Eligible participants include English- or Spanish-speaking women aged 18-89 years undergoing apical suspension with concomitant vaginal repairs. Participants will be randomized in a 1:1 ratio to either a control arm receiving standard ERAS postoperative care or an intervention arm receiving standard ERAS care plus tizanidine 4 mg three times daily for two weeks postoperatively.

Data collection will include demographic, medical, surgical, and healthcare utilization information, as well as validated surveys administered preoperatively, on postoperative day 1-2, at 2 weeks, and at 4-6 weeks postoperatively. The primary outcome is patient-reported outcome (PRO) assessed at 4-6 weeks postoperatively. Secondary outcomes include pain and recovery measures, opioid use, constipation, and healthcare utilization including readmissions, ED visits, telephone encounters, patient portal messages, and additional pain medication prescriptions. The study aims to recruit 186 patients to achieve 150 completed participants. Findings may help investigate a postoperative pain regimen that could decrease opioid use and improve postoperative recovery in urogynecologic patients.

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome (PRO)
Time Frame: 4-6 weeks post-operatively

Patient-reported outcome (PRO) assessed at 4-6 weeks post-operatively is the primary outcome. The PRO is a single question survey "To what extent do you feel physically recovered after surgery" that identifies a patient's perceived post-operative recovery with recent publication of content validity in urogynecology research.

Answer choices are "I don't feel at all recovered," "I feel recovered up to 25%," "I feel recovered up to 50%," "I feel recovered up to 75%," and "I feel fully recovered."
4-6 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain and Recovery-objective
Time Frame: 4-6 weeks post-operatively
Composite outcome assessed at 4-6 weeks post-operatively and includes pain and recovery according to objective and subjective criteria: objective criteria -- morphine milligram equivalents (MME) used
4-6 weeks post-operatively
Pain and Recovery- subjective
Time Frame: 4-6 weeks

Composite outcome assessed at 4-6 weeks post-operatively and includes pain and recovery according to objective and subjective criteria: subjective criteria -- validated surveys (AAS, GSR, PRO, BPI-SF)

Activity Assessment Scale, min score 0, max score 100, higher score is better function Global Surgical Recovery, min score 0%, max score 100%, higher score is better recovery Brief Pain Inventory-Short Form, min score 0, max score 10 per item. higher scire is worse pain
4-6 weeks
Healthcare Utilization
Time Frame: 6 weeks post-operative
Healthcare utilization will be assessed by readmission, ED visits, telephone visits, patient portal messages, additional pain meds prescribed (including refills) within 4-6 weeks postoperatively.
6 weeks post-operative
Constipation
Time Frame: 2 weeks post-operative

Constipation will be measured with constipation scoring system (CSS).

CSS, min score 0, max score 30, higher score means worse constipation
2 weeks post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

  • Study Director: Elena Tunitsky, MD, Hartford Healthcare
  • Principal Investigator: Sindhura Vallabhaneni, MD, Hartford Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 29, 2026

Primary Completion (Estimated)

July 29, 2028

Study Completion (Estimated)

July 29, 2028

Study Registration Dates

First Submitted

July 31, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHC-2026-0118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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