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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04568837
Other study ID # STUDY00021169
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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