Postoperative tizanidine addition after pelvic reconstructive surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, two-arm pilot study enrolling adult women undergoing apical suspension procedures at Hartford Hospital. Participants will receive standard postoperative care with or without tizanidine for two weeks after surgery and will complete electronic surveys at baseline, 1-2 days, 2 weeks, and 4-6 weeks postoperatively to assess pain, recovery, activity, and bowel function. The trial aims to determine if tizanidine improves patient-reported recovery and reduces pain, opioid use, constipation, and healthcare utilization. It is conducted within the context of Enhanced Recovery After Surgery (ERAS) pathways and focuses on addressing pelvic floor muscle-related pain. The study is prospective, longitudinal, non-blinded, and compares the adjunct tizanidine approach to standard care alone.

Why it matters

Who can join: the full rules

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 \<18 or ≥90 years old
  * pregnant
  * breastfeeding
  * documented diagnosis of hypotension in EMR problem list, BP in office or at pre-op PAC (confirmed on repeat) to be systolic \<100 mm Hg and/or diastolic \<70 mm Hg
  * known intolerance or sensitivity to tizanidine
  * current use of:

    * CYP1A2 inhibitor:
    * clonidine (alpha-2 agonist) antihypertensive
    * opioid
    * muscle relaxant
  * pre-existing

    * hepatic impairment as defined as transaminitis with ALT or AST \>2x upper limit of normal
    * diagnoses of cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD)
    * renal impairment as defined by creatinine clearance \<25 mL/min
  * obstructive sleep apnea
  * non-English or non-Spanish speaking
  * past opioid dependence
  * concurrent diagnosis of malignancy
  * concurrent surgery apart from pelvic reconstructive surgery with another specialty
  * unable/unwilling to consent to participate

Where it's running

• Hartford Hospital
  Hartford, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Sindhura Vallabhaneni, MD — Hartford HealthCare
• Study coordinator: Sindhura Vallabhaneni, MD
• Email: Sindhura.Vallabhaneni@hhchealth.org
• Phone: (860) 972-4338

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combined PECS II and PIP blocks vs TPVB for post-mastectomy pain relief

  This trial tests whether a combination of PECS II and superficial PIP blocks can provide better or similar pain relief after mastectomy compared with the standard thoracic paravertebral block.

  Recruiting Dharmais National Cancer Center Hospital · Jakarta, DKI Jakarta · NCT07738770

• Low vs. standard volume EXORA block for pain control in laparoscopic gallbladder surgery

  This trial tests whether a smaller amount of local anesthetic given as a bilateral EXORA block provides pain relief after laparoscopic cholecystectomy.

  Recruiting Fayoum University Hospital · El Fayoum Qesm, Faiyum Governorate · NCT07507799

• Peripheral autonomic plus TAP blocks for pain after minimally invasive left-sided colorectal surgery

  This will try adding a peripheral autonomic block (targeting the superior hypogastric and inferior mesenteric plexuses) plus a TAP block to standard pain control in adults having elective minimally invasive left-sided colorectal surgery to see if it reduces pain and opioid use in the first 48 hours.

  Recruiting Faculdade de Ciências Médicas de Minas Gerais · Belo Horizonte, Minas Gerais · NCT07388953

• Dexmedetomidine versus dexamethasone added to ropivacaine for supraclavicular nerve block in upper‑limb surgery

  This test compares two medicines added to ropivacaine to see which gives faster onset and longer pain relief for adults having upper‑limb surgery with an ultrasound‑guided supraclavicular nerve block.

  Recruiting Phase 2/3 Sahiwal medical college sahiwal · Sāhīwāl, Punjab Province · NCT07290595

• Adding targeted posterior knee nerve blocks to the adductor canal block for pain control after total knee replacement

  This trial will test whether adding one of three different posterior knee nerve blocks to a standard adductor canal block reduces pain and opioid use for adults having a single total knee replacement.

  Recruiting Erzincan University · Erzincan, Merkez · NCT07242170

• Perioperative Lidocaine in Enhanced Recovery After Major Non-Cardiac Surgery

  This trial tests whether giving IV lidocaine during major non-cardiac surgery helps recovery and reduces opioid use in adults within an ERAS program.

  Recruiting Phase 4 Vanderbilt University Medical Center · Nashville, Tennessee · NCT07224711

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.