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Can surgery pain be managed without opioids?

NCT ID NCT07771049

Symptom relief Sponsor: Hospital Universitario La Fe 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial asks whether an opioid-free anesthesia method can control acute pain after laparoscopic colorectal surgery as well as or better than standard opioid-based anesthesia. Adults aged 18 to 90 scheduled for this surgery will be randomly assigned to receive either a combination of non-opioid pain medicines or conventional opioids during and after the procedure. The main goal is to compare pain intensity and the need for extra rescue pain medication in the first 24 hours after surgery, while also tracking side effects, recovery quality, and hospital discharge time.

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 using a combination of dexmedetomidine, lidocaine, ketamine, magnesium sulfate, dexamethasone, and NSAIDs
What this could lead to
If it works, this could offer a safer way to manage surgical pain without opioid side effects, potentially speeding recovery and reducing hospital stays.
What could go wrong
This is an early-phase trial, so the opioid-free approach may not control pain as effectively as standard opioids, and the drug combination carries its own risks, such as low blood pressure or sedation.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 200 people

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

Started

Mar 2025

Expected to finish

Dec 2028

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 90 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: * Adult patients aged 18 to 90 years old of any sex. * Diagnosed with colorectal cancer (any type and stage). * Scheduled for elective laparoscopic colorectal surgery in the Lanzarote Health Area. * Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III. * Ability to understand the study procedures and signed written informed consent. Exclusion Criteria: * Known allergy or hypersensitivity to any of the study drugs. * Elevated intraocular pressure or history of intracranial lesions with a risk of elevated intracranial pressure. * History of traumatic brain injury (TBI) or epileptic seizures. * Severe psychiatric disease that may interfere with pain evaluation or outcome assessment. * Hyperthyroidism or currently undergoing thyroid replacement therapy. * Severe cardiac history, including congestive heart failure, severe coronary artery disease, poorly controlled tachyarrhythmias or bradyarrhythmias, or difficult-to-control arterial hypertension. * Baseline oxygen saturation (SpO2) \< 90% on room air. * Moderate or severe renal or hepatic insufficiency. * Pathologies associated with hypersalivation or swallowing difficulties. * Pregnancy or currently lactating.

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Conditions

The condition(s) this trial relates to.

agnosia colorectal cancer Postoperative Complications

As listed by the trial registrant

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

Colorectal surgery Opioid-free anesthesia Pain management Postoperative complications

Contacts and locations

Locations

  • Doctor Jose Molina Orosa

    Arrecife, Spain

  • Royo Villanova

    Zaragoza, Spain

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