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Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

NCT07766837 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-08-17

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Elena Tunitsky, MD · Hartford HealthCare

  • Sindhura Vallabhaneni, MD · Hartford HealthCare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-29
Primary Completion
2028-07-29
Completion
2028-07-29
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766837 on ClinicalTrials.gov