Affective Effects of Pre-surgery Opioids: a Randomized, Doubleblind Placebo-controlled Trial

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

1. To investigate and compare the affective short-term effects of opioid drugs: morphine, oxycodone and fentanyl, administered to the patients before the induction of general anesthesia.

2. Charting opioid use after surgery in patients treated at hospitals in Norway

3. Identify predictors for postoperative opioid use and persistent pain

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: Vestre VikenHF Kongsberg Sykehus
• Treatments: Fentanyl; Morphine; Oxycodone

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