Tizanidine for Postoperative Recovery
(TIPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Sindhura Vallabhaneni, MD
Principal Investigator
Hartford HealthCare
Elena Tunitsky, MD
Principal Investigator
Hartford HealthCare
Are You a Good Fit for This Trial?
This trial is for women aged 18 to 89 who are having certain types of pelvic reconstructive surgery at Hartford Hospital and can speak English or Spanish. Eligible surgeries include sacrocolpopexy, sacrospinous ligament fixation, iliococcygeus suspension, or uterosacral ligament suspension.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Tizanidine
Trial Overview
The study compares standard pain management after pelvic surgery with and without adding tizanidine (a muscle relaxant) for two weeks. Participants are randomly assigned to one group or the other and complete surveys about their recovery over six weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hartford Hospital
Lead Sponsor
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