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Drug combo may stop opioids from making pain worse after surgery

NCT ID NCT01594047

Symptom relief Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 giving ketamine during surgery and methadone after surgery can prevent a condition called opioid-induced hyperalgesia, where painkillers actually make pain worse. 113 patients having open colorectal surgery took part. Researchers measured the area of increased pain sensitivity around the surgical wound and pain levels using a 0-10 scale.

What this could mean

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

Active substance
ketamine and methadone
What this could lead to
If successful, this approach could help reduce pain and the need for strong painkillers after surgery.
What could go wrong
This is a small, completed study. Results may not apply to all surgeries or patients. Ketamine and methadone have side effects like drowsiness and nausea.

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

113 people

The number who actually took part.

Started

Dec 2009

Finished

Aug 2014

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: * patients undergoing open colo-rectal surgery Exclusion Criteria: * ASA status more than II, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. Body Max Index more than 35.

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Conditions

The condition(s) this trial relates to.

Hyperalgesia Pain, Postoperative

As listed by the trial registrant

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

Hyperalgesia Post operative pain

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

More trials for these conditions

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