Pain, Postoperative Clinical Trial
— METASPINEOfficial title:
Intraoperative Methadone for Postoperative Pain Management in Spinal Fusion Surgery: a Prospective, Double-blind, Randomised Controlled Trial
A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing spinal fusion.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | May 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid consumption (mean cumulative MME) | Opioid consumption within the first 6 hours after extubation | 6 hours | |
Primary | Opioid consumption (mean cumulative MME) | Opioid consumption within the first 24 hours after extubation | 24 hours | |
Secondary | Pain intensity (NRS, 0-10) at rest and coughing | Pain intensity from 0-10 in the affected area at when patient is at rest and coughing at the hours: 1, 3, 6, 24, 48 and 72 after extubation | 1-72 hours | |
Secondary | Patient satisfaction with pain management | Satisfaction with pain management, measured from 0-10, 24 hours following extubation | 24 hours | |
Secondary | Nausea and/or vomiting (PONV) | Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) at 6 and 24 hours. | 6 - 24 hours | |
Secondary | Readiness to discharge | Time from arrival to readiness for discharge from PACU(hours and minutes), | 2-24 hours | |
Secondary | Level of sedation | Level of sedation at observation in the PACU (Ramsay Sedation Scale at 1 hour after extubation) | 1 hour | |
Secondary | Adverse events | Any adverse events in the PACU
Hypoventilation (respiratory rate < 10/minutes) Hypoxemia (peripheral oxygen saturation < 94%) |
1-24 hours | |
Secondary | Given treatment according to patient and investigator | Patient and investigator are asked to asses which treatment they believe was given | 24 hours | |
Secondary | 3 months follow-up | Pain (NRS 0-10 in the surgical area and legs (left and right), analgesic consumption (opioids MME and secondary analgesics) and quality ogf life (Eq5D) | 3 months |
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