None listed
Conditions
Brief summary
The SPADE study is a trial of a medication called dexmedetomidine to determine if it is effective at treating pain after spinal fusion surgery. The medication will be compared against an inactive placebo. The investigators anticipate that dexmedetomidine will be effective at reducing pain after spinal fusion surgery, but this medication has not been trialled in this setting before. The trial will involve adults having spinal fusion surgery, and will be conducted at the Royal Melbourne Hospital. If the trial shows that dexmedetomidine is effective, it will facilitate improved pain relief for patients having spinal fusion surgery. If the trial does not show that dexmedetomidine is effective, it will allow the investigators to focus on other interventions to control pain.
Interventions
Dexmedetomidine by intravenous infusion started immediately after intubation, dosed as a loading dose of 0.5microg/kg over 10 minutes, followed by an infusion of 0.5microg/kg/hr ceased at the start of skin suturing (the functional end of the operation).
Protocol adherence will be audited in each case to ensure adequate compliance with the protocol.
Sponsors
The Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults 18 years and older having thoracic and/or lumbar spinal fusion surgery using a posterior approach. • Anticipated to stay at least one post-operative night in hospital.
Exclusion criteria
• Unable or unwilling to provide consent or unable to communicate numerical rating scale pain score, including cognitively impaired, planned to remain on mechanical ventilation post-operatively or non-English speaking patients. • Known diagnosis of significant cardiac conduction disease (second- or third-degree heart block, sick sinus syndrome, atrial fibrillation and atrial flutter) unless a pacemaker is present. • Known diagnosis of severe ischemic heart disease, valvular heart disease or cardiomyopathy • Known diagnosis of liver cirrhosis • Bradycardia (heart rate (HR) < 50 bpm) in theatre suite before surgery • Hypotension (systolic blood pressure (SBP) < 100 mmHg) in theatre suite before surgery • Known diagnosis of allergy or hypersensitivity reactions to dexmedetomidine or any of the protocolised anaesthetic drugs. • Previously enrolled into the SPADE study.
Outcome results
None listed