Steroids After Spine Fusion Surgery

This study is looking at whether giving a low dose of steroids (Prednisone or Dexamethasone Sodium Phosphate) after spine fusion surgery helps patients recover. Researchers want to see if these steroids can reduce pain medication use, shorten your hospital stay, and help your bowels start working sooner after surgery. You could join if you are over 50 and having thoracic (upper back) or lumbar (lower back) spine fusion surgery. You cannot join if you are already taking steroids, are pregnant, or cannot make your own medical decisions. The study is currently unclear about its recruitment status.

Study design
This is an interventional study with a planned enrollment of 420 participants. Participants will be randomly assigned to receive either the steroid medication or no treatment after surgery.
What's involved
If you are in the study drug group, you will take 20 mg of Prednisone (or Dexamethasone Sodium Phosphate if you can't take pills) on the first two days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your pain medication use, hospital stay, and time to first bowel movement will be measured from after surgery until discharge, up to 4 weeks.

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NCT04568837

Steroids After Spine Fusion Surgery

Not Yet Recruiting
PHASE4Ages 50+InterventionalTreatment
Oregon Health and Science University
~420 participants
Updated 2024-04-22 on ClinicalTrials.gov
What's tested:Prednisone 20 Mg

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Morphine equivalent pain medication use over the length of hospitalization
Measured over From postoperative admission to discharge, up to 4 weeks
+4 more outcomes measured
Spine Fusion
1 sites across 1 states
Oregon1
  • Jung U Yoo, MD · PRINCIPAL_INVESTIGATOR · Department of Orthopaedics and Rehabilitation

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Eligibility criteria

Inclusion

All patients over the age of 50 undergoing thoracic and/or lumbar fusion with a Spine Center surgeon will be included

Exclusion

Patient is already taking chronic steroids
Patient is pregnant
Patient is decisionally impaired
Patient is a prisoner
  • Morphine equivalent pain medication use over the length of hospitalizationFrom postoperative admission to discharge, up to 4 weeks

    This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.

  • Length of hospital stay after surgeryFrom postoperative admission to discharge, up to 4 weeks

    This will be measured by taking the total minutes the patient stays in the hospital after surgery from time of admission to time of discharge.

  • Time to first bowel movement in hospital after surgeryFrom postoperative admission to discharge, up to 4 weeks

    This will be measured in the total number of minutes from admission after surgery that it takes for the patient to have their first bowel movement recorded.

  • Number of major complications reported during hospital stay after surgeryFrom postoperative admission to discharge, up to 4 weeks

    This will be measured in the total number of major complications (any) that occur during the hospital stay after surgery. These include, infection, neurological deficit, myocardial infarction, stroke, pneumonia, pulmonary embolism, and bleeding.

  • Morphine equivalent pain medication use over the first 48 hours of hospitalizationFrom postoperative admission to 48 hours after

    This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.