Health TrialsbyHealthPanel

Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

ConditionsPost OperativePost Operative AnalgesiaUrogynecologic Surgery
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Intervention/TizanidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient Reported Outcome (PRO)

Patient-reported outcome (PRO) assessed at 4-6 weeks post-operatively is the primary outcome. The PRO is a single question survey "To what extent do you feel physically recovered after surgery" that identifies a patient's perceived post-operative recovery with recent publication of content validity in urogynecology research. Answer choices are "I don't feel at all recovered," "I feel recovered up to 25%," "I feel recovered up to 50%," "I feel recovered up to 75%," and "I feel fully recovered."

Time frame
4-6 weeks post-operatively

Secondary outcomes

1

Pain and Recovery-objective

Composite outcome assessed at 4-6 weeks post-operatively and includes pain and recovery according to objective and subjective criteria: objective criteria -- morphine milligram equivalents (MME) used

Time frame
4-6 weeks post-operatively
2

Pain and Recovery- subjective

Composite outcome assessed at 4-6 weeks post-operatively and includes pain and recovery according to objective and subjective criteria: subjective criteria -- validated surveys (AAS, GSR, PRO, BPI-SF) Activity Assessment Scale, min score 0, max score 100, higher score is better function Global Surgical Recovery, min score 0%, max score 100%, higher score is better recovery Brief Pain Inventory-Short Form, min score 0, max score 10 per item. higher scire is worse pain

Time frame
4-6 weeks
3

Healthcare Utilization

Healthcare utilization will be assessed by readmission, ED visits, telephone visits, patient portal messages, additional pain meds prescribed (including refills) within 4-6 weeks postoperatively.

Time frame
6 weeks post-operative
4

Constipation

Constipation will be measured with constipation scoring system (CSS). CSS, min score 0, max score 30, higher score means worse constipation

Time frame
2 weeks post-operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hartford Hospital

Lead sponsor

Source ClinicalTrials.gov
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