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

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

Plain Language Summary

Simplified for easier understanding

Spinal fusion surgery — an operation to join vertebrae in the spine — is performed for conditions like disc disease, spinal instability, and deformity, but it can cause significant pain in the days afterward. Good pain management after surgery helps patients recover faster and reduces the need for strong opioid painkillers. This trial tests whether dexmedetomidine — a sedative drug with pain-relieving properties sometimes used in intensive care — can reduce pain scores after spinal fusion surgery. You may be eligible if you are 18 or older, are having thoracic or lumbar spinal fusion surgery using a posterior (back of the spine) approach at the Royal Melbourne Hospital, and plan to stay at least one night in hospital. People with significant cardiac conduction problems, severe heart disease, liver cirrhosis, low heart rate or blood pressure before surgery, or a known allergy to dexmedetomidine are not eligible. Participants are randomly assigned to receive dexmedetomidine or a saline placebo infusion during and after surgery, with neither them nor their doctors knowing which is which. Pain scores, opioid use, and side effects are tracked over the following days. If effective, dexmedetomidine could offer a valuable new option in the multimodal approach to post-operative pain management for spinal surgery.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

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ACTRN12621000557831


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