Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-89
SponsorHartford Hospital

About 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.

Eligibility criteria

Qualifiers

female, age ≥18 and ≤89 years old

any race/ethnicity

English and/or Spanish fluency

sacrocolpopexy (laparoscopic or robotic)

Disqualifiers

male

age <18 or ≥90 years old

pregnant

breastfeeding

Trial design

Treatments tested in this trial

  • Tizanidine
  • Standard-of-Care Therapy

Treatment groups

186 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators