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Opioid-Free anesthesia: a safer way to go under the knife?

NCT ID NCT06380244

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This study compares opioid-free anesthesia to standard opioid-based anesthesia in 600 adults undergoing urological abdominal surgery. The goal is to see if avoiding opioids during surgery reduces the need for painkillers afterward and lowers side effects like nausea. Patients will be followed for 24 hours after their operation.

What this could mean

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

Active substance
opioid-free anesthesia (dexmedetomidine, ketamine, lidocaine, NSAIDs, regional analgesia)
What this could lead to
If successful, this could offer a safer way to manage pain during surgery, reducing opioid use and related side effects like nausea and vomiting.
What could go wrong
This is an early-stage study with 600 patients, and results may not apply to all surgeries. The opioid-free approach might not control pain as well as standard methods.

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 600 people

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

Started

Apr 2024

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 to 75 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: * Adults aged 18-75 years scheduled for elective urological surgery under general anesthesia: laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy. * Ability to operate a patient-controlled analgesia (PCA) pump postoperatively. * Ability to understand and use the Numeric Rating Scale (NRS) for pain assessment. * Written informed consent. Exclusion Criteria: * Patient's refusal to participate. * Inability to operate the PCA pump. * Inability to understand the NRS pain scale. * Known hypersensitivity to any of the study drugs (anesthetics, ketamine, dexmedetomidine, ropivacaine, oxycodone, metamizole, paracetamol, ibuprofen). * Second- or third-degree atrioventricular block, or symptomatic bradycardia. * Chronic opioid use. * Contraindication to the planned regional anesthesia technique (e.g. coagulopathy or therapeutic anticoagulation, infection at the puncture site).

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Conditions

The condition(s) this trial relates to.

urinary system neoplasm

As listed by the trial registrant

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

Analgesics, opioid Anesthesia, endotracheal Anesthesia, general

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

  • Jagiellonian University

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31501, Poland

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