Methadone for pain following spinal surgery

Phase 1

• Conditions: ow back pain; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-004826-47-DK
• Lead Sponsor: one Nikolajsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-22
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

All patients (=18 years) scheduled for elective spine surgery are screened for inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

•Allergy to study drugs
•American Society of Anaesthesiologists (ASA) physical status IV or V
•Prolonged QTc-interval assessed by electrocardiogram (Male: >450 milliseconds, Female: >460 milliseconds)
•Inability to provide informed consent
•Severe respiratory insufficiency (Oxygen treatment at home)
•Heart failure
•Acute alcohol intoxication/delirium tremens
•Increased intracranial pressure
•Acute liver disease
•Acute abdominal pain
•Liver insufficiency
•Kidney insufficiency (eGFR<30)
•Pregnancy or breastfeeding
•Existing treatment with medications prolonging the QT-interval (see appendix for details)
•Existing treatment with opioids (at least the last 7 days) exceeding 60 mg morphine equivalents daily
•Planned postoperative treatment with epidural analgesics and/or ketamine infusion
•Treatment with rifampicin
•Spinal surgery due to malignant disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified