Effects of opioids on mood before surgery

Understanding Opioid Use Before and After Surgery in Norway: A Prospective Multicenter Study and Randomized Double-blind Controlled Study

This study tests how different doses of opioids given to patients before surgery affect their mood and emotional responses.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Oslo University Hospital (other)
• Locations: 1 site (Oslo)
• Trial ID: NCT05639712 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the short-term affective effects of three opioid analgesics—morphine, oxycodone, and fentanyl—administered to patients prior to general anesthesia. It employs a randomized, double-blind, placebo-controlled design to compare the emotional responses of patients receiving different doses of these opioids. Additionally, the study aims to track postoperative opioid use and identify predictors for persistent pain following surgery. The research is conducted in a clinical setting to assess both physiological and psychological stress responses.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults classified as ASA1 or ASA2, who are undergoing day surgery and meet specific criteria for opioid use.

Not a fit: Patients with significant health issues or contraindications for opioid use may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies and better emotional outcomes for patients undergoing surgery.

How similar studies have performed: Other studies have explored the effects of opioids on mood, but this specific approach comparing multiple opioids in a controlled setting is relatively novel.

Eligibility criteria

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

Where this trial is running

Oslo

• Harald Lenz — Oslo, Norway (RECRUITING)

Study contacts

• Principal investigator: Gernot Ernst, MD,PhD — Kongsberg Hospital, Vestre Viken Health Trust Norway
• Study coordinator: Gernot Ernst, MD, PhD

Conditions: Opioid Use, Affective Symptoms