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

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

Conditions

• Opioid Use
• Affective Symptoms

Interventions

DRUG

Placebo

The patient is given standardized questions about their well-being and affective state before and after the administration of placebo intravenously. This is carried out on the operating table right before anesthesia

DRUG

Morphine 2.5 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of 2.5 mg morphine intravenously. This is carried out on the operating table right before anesthesia

DRUG

Morphine 5 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of morphine 5 mg intravenously . This is carried out on the operating table right before anesthesia

DRUG

Morphine 10 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of morphine 10 mg intravenously . This is carried out on the operating table right before anesthesia

DRUG

Oxycodone 2.5 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of oxycodone 2.5 mg intravenously . This is carried out on the operating table right before anesthesia

DRUG

Oxycodone 5 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of oxycodone 5 mg intravenously . This is carried out on the operating table right before anesthesia

DRUG

Oxycodone 10 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of oxycodone 10 mg intravenously . This is carried out on the operating table right before anesthesia

DRUG

Fentanyl 0.025 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of fentanyl 0.025 mg intravenously . This is carried out on the operating table right before anesthesia

DRUG

Fentanyl 0.05 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of fentanyl 0.05 mg intravenously . This is carried out on the operating table right before anesthesia

DRUG

Fentanyl 0.1 mg i.v.

The patient is given standardized questions about their well-being and affective state before and after the administration of fentanyl 0.1 mg intravenously . This is carried out on the operating table right before anesthesia

Sponsors & Collaborators

• Vestre VikenHF Kongsberg Sykehus

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Gernot Ernst, MD,PhD · Kongsberg Hospital, Vestre Viken Health Trust Norway

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-13

Primary Completion

2025-05-27

Completion

2025-06-27

Countries

• Norway

Study Locations