Methadone for Spinal Fusion Surgery.

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing spinal fusion.

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

Details

• Lead Sponsor: Aarhus University Hospital
• Treatments: Methadone; Morphine

Criteria

Inclusion Criteria:

• All patients (≥18 years ≤85) scheduled for elective spinal fusion surgery are screened for inclusion.

Exclusion Criteria:

• Allergy to study drugs

• American Society of Anaesthesiologists (ASA) physical status IV or V

• Prolonged QTc-interval assessed by electrocardiogram(> 440 milliseconds)

• Inability to provide informed consent

• Severe respiratory insufficiency(Oxygen treatment at home)

• Known or clinical signs of heart failure (Ejection Fraction <30%)

• Acute alcohol intoxication/delirium tremens

• Known or clinical signs of increased intracranial pressure

• Acute liver disease

• Acute abdominal pain

• Known or clinical signs of severe liver dysfunction (cirrhosis, inflammation/hepatitis or liver malignancies)

• Known or clinical signs of severe kidney insufficiency(eGFR<30)

• Pregnancy: women of childbearing potential will be tested with serum-HCG prior to surgery, unless the woman is using a birth control method that may be considered as highly effective (based on CTFG 'recommendations related to contraception and pregnancy testing in clinical trials'). Women of childbearing potential is defined as women between menarche and post-menopausal, unless permanently steril. Post-menopausal is defined as no menses for 12 months without alternative medical cause.

• Breastfeeding mothers

• Existing treatment with a high risk of QTc-interval prolongation

• Existing treatment with opioids (at least the last 7days) exceeding 60 mg morphine equivalents daily

• Planned postoperative treatment with epidural analgesics and/or ketamine infusion

• Treatment with rifampicin

• Spinal fusion surgery over >4vertebral levels

• Spinal fusion surgery due to malignant disease