Steroids After Spine Fusion Surgery

Spine Fusion Clinical Trial

Official title:

Postoperative Steroids and Recovery After Spine Fusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04568837
• Other study ID #: STUDY00021169
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2025
• Est. completion date: October 6, 2026

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: Spencer J Smith, BS
• Phone: 503-828-7136
• Email: smithsp[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVES This study aims to compare patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) between subjects that receive either 20 mg of PO prednisone or 1 mL of 4 mg/mL of IV dexamethasone sodium phosphate and a control group. OUTLINE Participants are patients who elect to participate in the study prior to scheduled thoracic and/or lumbar spine fusion surgery at Oregon Health and Science University. Participants undergo their scheduled spine fusion surgery. After surgery, participants are randomized into either the study drug group or the control (non-treatment) group. If randomized into the study drug group, participants will orally take a daily dose of 20 mg of prednisone (1 mL of 4 mg/mL dexamethasone sodium phosphate if unable to tolerate oral administration) on postoperative days one and two.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: October 6, 2026
• Est. primary completion date: October 6, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient is already taking chronic steroids
• Patient is pregnant
• Patient is decisionally impaired
• Patient is a prisoner

Related Conditions & MeSH terms

• Spine Fusion

Intervention

Drug:
• Prednisone 20 Mg
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

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From postoperative admission to discharge, up to 4 weeks
Primary	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.	From postoperative admission to discharge, up to 4 weeks
Primary	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.	From postoperative admission to discharge, up to 4 weeks
Primary	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.	From postoperative admission to discharge, up to 4 weeks
Primary	Morphine equivalent pain medication use over the first 48 hours of hospitalization	This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.	From postoperative admission to 48 hours after