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Could a simple IV drug replace needles for knee surgery pain?

NCT ID NCT04828083

Symptom relief Sponsor: Rhode Island Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving lidocaine through an IV works as well as an ultrasound-guided nerve block for controlling pain after total knee replacement. 120 adults having knee surgery were randomly assigned to receive either IV lidocaine or a saline placebo (with the nerve block group getting the opposite). The main goal was to see if IV lidocaine could reduce the amount of opioids needed after surgery.

What this could mean

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

Active substance
lidocaine
What this could lead to
If IV lidocaine works as well as a nerve block, it could offer a simpler, needle-free option for managing pain after knee replacement surgery.
What could go wrong
This is a small, completed Phase 4 trial with only 120 participants. The results may not apply to everyone, and IV lidocaine can have side effects like dizziness or heart issues.

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

120 people

The number who actually took part.

Started

Mar 2021

Finished

Sep 2024

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 80 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: * ASA PS 1-3 patients undergoing primary, unilateral total knee arthroplasty Exclusion Criteria: * ASA PS classification of 4 or greater * Pre-existing neuropathy * Coagulopathy * Chronic opioid consumption (\>3 months) * Infection at the site * Known allergy to study medications (lidocaine) * High grade atrioventricular block (cardiac conduction system impairment) * A history of CVA/TIA * Currently using lidocaine patches * Known liver disease

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As listed by the trial registrant

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

Arthroplasty, replacement, knee Total knee arthroplasty

Contacts and locations

Locations

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

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