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Could a simple tourniquet change cut Post-Surgery pain and opioid use?

NCT ID NCT04390425

Symptom relief Sponsor: The Methodist Hospital Research Institute 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a lower-pressure tourniquet during orthopedic surgeries can reduce pain and the need for opioid painkillers afterward. Standard tourniquets use high pressure, which can cause muscle weakness and pain. The experimental device sets pressure based on the patient's blood pressure plus a safety margin. Researchers are enrolling 400 adults undergoing common procedures like knee replacement or carpal tunnel release.

What this could mean

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

Active substance
Limb occlusion pressure tourniquet (device)
What this could lead to
If it works, this could offer a simple way to reduce pain and opioid use after common orthopedic surgeries.
What could go wrong
This is a mid-sized study testing a device modification, not a new drug. The benefit may be small or not apply to all surgeries.

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 400 people

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

Started

Apr 2018

Expected to finish

Dec 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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * The research team will test the central hypothesis that LOP tourniquets will decrease pain and opioid use and improve patients outcomes on healthy adults (above the age of 18) undergoing either open carpal tunnel release, open reduction internal fixation distal radius fracture, cubital tunnel release, trigger finger release, thumb CMC arthroplasty, anterior cruciate ligament reconstruction, or total knee replacements Exclusion Criteria: 1. Prescription pain medications for chronic conditions (\> 6 weeks) 2. Patients who cannot use a tourniquet:( ex. Certain patients with fistulas or PVD, certain patient with Peripheral Vascular Disease) 3. Prior trauma or surgery to the observed limb. 4. Hypotension or hypertension that prevents accurate distal photoplenthysmography probe reading.

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Conditions

The condition(s) this trial relates to.

carpal tunnel syndrome cubital tunnel syndrome osteoarthritis, hand osteoarthritis, knee radius fracture

As listed by the trial registrant

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

Limb occlusion pressure

Contacts and locations

Locations

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.