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New combo could ease pain after leg surgery

NCT ID NCT07310628

Symptom relief Sponsor: All India Institute of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether taking a pill called tizanidine before spinal anesthesia (levobupivacaine) improves pain control during and after lower leg surgery. Sixty-four adults scheduled for elective leg surgery were randomly assigned to receive either the standard spinal injection alone or with an added tizanidine pill. Researchers measured how quickly pain relief started, how long it lasted, and how much extra pain medicine was needed afterward.

What this could mean

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

Active substance
tizanidine and levobupivacaine
What this could lead to
If it works, this could lead to a simple, low-cost way to improve pain relief and reduce the need for additional painkillers after leg surgery.
What could go wrong
This is a small, completed Phase 4 trial with only 64 participants, so results may not apply to everyone. Tizanidine can cause side effects like drowsiness or low blood pressure.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

64 people

The number who actually took part.

Started

Aug 2022

Finished

Aug 2025

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 60 years

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: * patients aged 18 to 60 years with an ASA grade of I-II, who were scheduled for elective lower limb surgeries with a duration of less than 2 hours and 30 mins. Exclusion Criteria: * Patients with certain conditions such as pregnancy, coagulopathy, cerebrovascular disease, systemic infections, inability to understand the study protocol, allergy to local anaesthetics, psychiatric disorders affecting evaluation, infection at the injection site, kidney and liver diseases, myelopathy or peripheral neuropathy, spinal stenosis, prior spinal surgeries, raised intracranial pressure, multiple sclerosis, spina bifida, those receiving thromboprophylaxis and refusal to participate in the study were excluded.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome

As listed by the trial registrant

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

Levobupicaine Lower limb surgery Pain, chronic Tizanididne

Contacts and locations

Locations

  • Adabala Vijay Babu

    Raebareli, Uttar Pradesh, 229405, India

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