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NCT07766837
Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study
Conditions: Post Operative, Post Operative Analgesia, Urogynecologic Surgery
Sex: Female
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 186
Sponsor: Hartford Hospital
Location: Hartford Hospital Hartford Connecticut
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07766837). StuddyBuddy aggregates publicly available trial information.