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Opioid study reveals how painkillers affect mood before surgery

NCT ID NCT05639712

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study in Norway looked at how opioids like morphine, oxycodone, and fentanyl affect patients' mood and pain right before surgery. Over 1,000 healthy adults scheduled for day surgery answered questions about anxiety, relaxation, and pain after receiving a small dose of opioid or a placebo. The study also tracked how much pain medication patients needed after surgery and what factors predicted long-term opioid use or persistent pain.

What this could mean

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

Active substance
Morphine, oxycodone, fentanyl, and placebo (saline)
What this could lead to
If successful, this could help doctors understand how opioids affect mood and pain, potentially leading to better pain management after surgery.
What could go wrong
This is a completed Phase 4 study focused on observation and short-term effects, not a treatment trial. Results may not apply to all patient groups.

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

1,020 people

The number who actually took part.

Started

Dec 2022

Finished

Jun 2025

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 65 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: \- Health status ASA1 (American Society of Anesthesiologists physical status) or ASA2 as categorised by a medical doctor at the hospital based on medical history, physical examination, laboratory test etc. unrelated to the current study. ASA1 and ASA2 (ASA1 is defined as "Healthy, non-smoking, no or minimal alcohol use" and ASA2 is defined as "Mild diseases only without substantive functional limitations). Being eligible for day surgery means participants are overtly healthy as determined by clinical staff. * The participant is considered as eligible for the use of fentanyl, morphine and oxycodone by a medical doctor at the hospital, based on an overall assessment of the psychiatric and somatic condition, used medical drugs, regarding possible interactions and contraindications for the use of the study medicaments. * Body weight and body mass index (BMI) within the range 18-35 kg/m2 (inclusive). * Capable of giving signed informed consent as which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Having good verbal communication skills in Norwegian. * Patients undergoing planned day surgery with general anesthesia (outpatient sample). * Orthopedic, rectal, gynecological, hand and foot surgery, and minor vascular procedures. * Inpatients undergoing planned gynecological and orthopedic surgery. * Hysterectomy, laparoscopic ovariectomy, lumbal herniotomy and other related procedures. * Minor gastrointestinal surgery Exclusion Criteria: 1. Known allergic reactions to morphine, oxycodone,or fentanyl. Known allergic reactions to any of the incredients described in the SPC, pt 6.1. 2. Severe chronic obstructive lung disease, 3. Cor pulmonale, 4. Severe bronchial asthma, 5. Severe respiratory failure with hypoxemia and hypercapnia 6. Moderate to severe hepatic impairment, 7. Moderate to severe kidney failure 8. Acute abdomen 9. Increased brain pressure 10. Head trauma 11. Use of MAO blockers in the last two weeks 12. Hypovolemia 13. Hypotension 14. Myasthenia gravis 15. Any other health status not corresponding to ASA1 or ASA2. This includes patients with severe disease burden, major psychiatric disorders that could interfere with the procedures and communication. 16. Pregnancy. Women of childbearing potential defined as all premenopausal female (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause) will be asked if they are pregnant. 17. Breastfeeding women. 18. Illegal drugs use like opioids, cocaine and amphetamine

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Conditions

The condition(s) this trial relates to.

Affective Symptoms opioid abuse

As listed by the trial registrant

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

Contacts and locations

Locations

  • Harald Lenz

    Oslo, Oslo, Norway

More trials for these conditions

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