Could a muscle relaxant speed up recovery after pelvic surgery?

NCT ID NCT07766837

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This pilot study tests whether adding tizanidine, a muscle relaxant, to the standard pain regimen improves recovery in women after pelvic reconstructive surgery. Participants are randomly assigned to receive either standard care alone or standard care plus tizanidine for two weeks after surgery. Researchers will compare pain, opioid use, bowel function, and patient-reported recovery over several weeks to see if tizanidine offers added benefits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tizanidine
What this could lead to
If effective, adding tizanidine to standard pain care could improve recovery, reduce opioid use, and ease constipation after pelvic reconstructive surgery.
What could go wrong
This is a small pilot study, so results may not be definitive. Tizanidine can cause drowsiness, dizziness, or low blood pressure, and may not improve recovery for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 186 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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