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

Phase 4

Recruiting

• Conditions: Pain; Spinal fusion surgery; Anaesthesiology - Anaesthetics; Neurological - Other neurological disorders

• Registration Number: ACTRN12621000557831
• Lead Sponsor: The Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-12
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain, as reported by the patient using the Numerical Rating Scale (NRS)[At 1 hour after arriving in the Post Anaesthetic Care Unit]