Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

Conditions

• Post Operative
• Post Operative Analgesia
• Urogynecologic Surgery

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Aug 17, 2026

Start date

Aug 21, 2026

Status verified

Sep 2026

Primary completion

Jul 29, 2028

Completion

Jul 29, 2028

Study Design

Enrollment

186 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Sindhura Vallabhaneni, MD
  (860) 972-4338
  [email protected]

Locations (1)

Find similar trials in Hartford, CT

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