Health TrialsbyHealthPanel

Steroids After Spine Fusion Surgery

ConditionSpine Fusion
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorOregon Health and Science University

About this trial

This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) after thoracic and/or lumbar spine fusion surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patient is already taking chronic steroids

Patient is pregnant

Patient is decisionally impaired

Patient is a prisoner

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisone 20 Mg

    Drug

    20 mg of Prednisone or 1 mL of 4 mg/mL Dexamethasone Sodium Phosphate will be administered each day for participants in the intervention group

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: CorticosteroidExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Morphine equivalent pain medication use over the length of hospitalization

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

Time frame
From postoperative admission to discharge, up to 4 weeks
2

Length of hospital stay after surgery

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 frame
From postoperative admission to discharge, up to 4 weeks
3

Time to first bowel movement in hospital after surgery

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.

Time frame
From postoperative admission to discharge, up to 4 weeks
4

Number of major complications reported during hospital stay after surgery

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.

Time frame
From postoperative admission to discharge, up to 4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: