Methadone for Spinal Fusion Surgery.

NCT04764825 | Terminated Phase 4 DMC

• 2 other identifiers: 894560492020-004826-47
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative; Back Pain; Opioid Use; Methadone; Degenerative Spondylolisthesis; Stenosis, Spinal

Keywords

methadone; postoperative; pain; spinalfusion

Outcome Measures

Primary Outcomes (2)

• Opioid consumption (mean cumulative MME)

  Opioid consumption within the first 6 hours after extubation

  6 hours

• Opioid consumption (mean cumulative MME)

  Opioid consumption within the first 24 hours after extubation

  24 hours

Secondary Outcomes (8)

• Pain intensity (NRS, 0-10) at rest and coughing

  1-72 hours

• Patient satisfaction with pain management

  24 hours

• Nausea and/or vomiting (PONV)

  6 - 24 hours

• Readiness to discharge

  2-24 hours

• Level of sedation

  1 hour

Study Arms (3)

Methadone, induction

EXPERIMENTAL

Patients receive methadone 0.15-0.2 mg/kg ideal bodyweight 10 minutes prior to surgery start (Syringe A). 45 minutes before expected extubation patients will receive saline (syringe B).

Drug: Methadone

Methadone, end of surgery

EXPERIMENTAL

Patients receive saline 10 minutes prior to surgery start (Syringe A). 45 minutes before expected extubation patients will receive methadone 0.15-0.2 mg/kg ideal bodyweight (syringe B).

Drug: Methadone

Morphine

ACTIVE COMPARATOR

Patients receive saline 10 minutes prior to surgery start (Syringe A). 45 minutes before expected extubation patients will receive morphine 0.15-0.2 mg/kg ideal bodyweight (syringe B).

Drug: Morphine

Interventions

Methadone DRUG

The dosage administered differ in regards to age and tolerance to opioids: 0.2 mg/kg: all patients \<65 years of age and all patients tolerant to opioids (defined as treatment with opioids (at least the last 7days) exceeding 60 oral morphine milligram equivalents daily. 0.15 mg/kg: Opioid naive patients \> 65 years of age.

Methadone, end of surgery; Methadone, induction

Morphine DRUG

The dosage administered differ in regards to age and tolerance to opioids: 0.2 mg/kg: all patients \<65 years of age and all patients tolerant to opioids (defined as treatment with opioids (at least the last 7days) exceeding 60 oral morphine milligram equivalents daily. 0.15 mg/kg: Opioid naive patients \> 65 years of age.

Morphine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative; Back Pain; Spinal Stenosis; Pain

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomisation list will be concealed until all statistical analyses are made.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: February 26, 2021
• Primary Completion: March 19, 2024
• Study Completion: July 1, 2024
• Last Updated: November 25, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)