RecruitingPhase 4ACTRN12621000557831

A randomised controlled trial of dexmedetomidine compared to placebo to reduce pain after spinal fusion surgery

Sponsor

The Royal Melbourne Hospital

Enrollment

128 participants

Start Date

May 24, 2021

Study Type

Interventional

Conditions

Spinal fusion surgery Pain

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

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 Criteria8

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.

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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.