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Intraoperative methadone for the prevention of postoperative pain: a randomized, double-blind clinical study in orthopedic surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518059-50-00
Acronym
CHUB-Methadone
Enrollment
80
Registered
2024-12-12
Start date
2023-03-01
Completion date
Unknown
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic surgery

Brief summary

Postoperative pain will be assessed by nurses in the recovery room and inpatient unit: total morphine consumption is noted and postoperative pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 to 10) at rest and during coughing at 11 different intervals. The level of sedation is also measured using a 5-point scale (Rudkin scale) and episodes of nausea and vomiting, side effects and complications are also encoded.

Detailed description

The pain is then evaluated during the three postoperative days thanks to the EVA but also via a general satisfaction questionnaire concerning the management of pain at the end of the stay. Side effects and complications are encoded.

Interventions

DRUGMEPHENON 10mg/1ml solution injectable
DRUGSufenta

Sponsors

Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Postoperative pain will be assessed by nurses in the recovery room and inpatient unit: total morphine consumption is noted and postoperative pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 to 10) at rest and during coughing at 11 different intervals. The level of sedation is also measured using a 5-point scale (Rudkin scale) and episodes of nausea and vomiting, side effects and complications are also encoded.

Secondary

MeasureTime frame
The pain is then evaluated during the three postoperative days thanks to the EVA but also via a general satisfaction questionnaire concerning the management of pain at the end of the stay. Side effects and complications are encoded.

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026