Low back pain
Conditions
Interventions
Trade Name: Methadone Streuli Sol Inj 10 mg/ml 10 AMPS 1 ML
Product Name: Methadon Streuli
Product Code: NO7BCO2
Pharmaceutical Form: Solution for injection
Product Name: Morphine
Pharmaceutical For
Sponsors
Lone Nikolajsen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Opioid consumption at 24 hours (mean cumulative opioid consumption) •Opioid consumption at 6 hours after extubation (mean cumulative opioid consumption) ;Secondary Objective: •Pain intensity (NRS, 0-10) in the surgical area at rest and coughing at 1, 3, 6, 24, 48 and 72 hours after extubation •Pain intensity (NRS 0-10) in the legs (left and right, respectively) at 24 and 48 hours •Patient satisfaction (NRS, 0-10) with pain management at 24 hours after extubation •Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) at 6 and 24 hours •Time from arrival to readiness for discharge from PACU (hours and minutes). •Level of sedation at observation at the PACU (Ramsay Sedation Scale) at 1 hour after extubation •Any adverse events during observation at the PACU: oHypoventilation (respiratory rate < 10/minutes) oHypoxemia (peripheral oxygen saturation < 94%) •Given treatment accordin to patient and investigator (24h) •3 months follow-up: EQ-5D, opioid consumption and pain intensity ;Primary end point(s): Opioid consumption;Timepoint(s) of evaluation of this end point: At 6 and 24 hours after extubation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pain intensity (NRS, 0-10) in the surgical area at rest and coughing • Pain intensity (NRS 0-10) in the legs (left and right, respectively) • Patient satisfaction (NRS, 0-10) with pain management • Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) • Time from arrival to readiness for discharge from PACU (hours and minutes). • Level of sedation at observation at the PACU (Ramsay Sedation Scale) • Any adverse events during observation at the PACU: o Hypoventilation (respiratory rate < 10/minutes) o Hypoxemia (peripheral oxygen saturation < 94%) • Given treatment accordin to patient and investigator • Follow-up: EQ-5D, opioid consumption and pain intensity ;Timepoint(s) of evaluation of this end point: Pain intensity, back: 1, 3, 6, 24, 48 and 72 hours after extubation Pain intensity, legs: 24 and 48 hours Patient satisfaction: 24 hours after extubation PONV: 6 and 24 hours Sedation: 1 hours Given treatment: 24 hours Followup: 3 months | — |
Countries
Denmark
Contacts
Public ContactLone Nikolajsen
Aarhus University Hospital
Outcome results
None listed