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One pill before surgery may cut opioid use and improve sleep

NCT ID NCT07800364

Symptom relief Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether taking a single oral dose of tizanidine, a muscle relaxant, before lower limb orthopedic surgery can reduce postoperative pain and improve sleep quality. Researchers will compare tizanidine against a placebo in 68 adults scheduled for surgery. They will measure how long patients go before asking for extra pain relief and how much opioid painkiller they use in the first 48 hours after surgery. The goal is to see if this simple pre-surgery step can lower opioid-related side effects and support better recovery.

What this could mean

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

Active substance
tizanidine, a muscle relaxant given as an oral tablet before surgery
What this could lead to
If it works, a single pre-surgery dose of tizanidine could reduce the need for strong opioids and improve sleep after lower limb surgery.
What could go wrong
This is a small early-stage trial, so results may not apply to everyone. Tizanidine can cause drowsiness, dizziness, or low blood pressure, and it may not improve pain or sleep as hoped.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 68 people

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

Started

Mar 2026

Expected to finish

Sep 2026

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

21 years and older

Sex

Anyone

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: * Adults aged ≥ 21 years * Scheduled for lower limb orthopedic surgery * Able to provide informed consent Exclusion Criteria: * History of hypersensitivity to tizanidine * Pregnancy or breastfeeding * Failure of spinal anesthesia or inadequate block.

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Conditions

The condition(s) this trial relates to.

Pain Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post operative pain The effect of preoperative administration of oral tizanidine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • tanta University hospital

    RECRUITING

    Tanta, Gharbia Governorate, Egypt

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