Steroids After Spine Fusion Surgery

NCT04568837 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00021169
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spine Fusion

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Corticosteroid

EXPERIMENTAL

Participants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery

Drug: Prednisone 20 Mg

Control

NO INTERVENTION

Participants in this group will receive no steroids on postoperative day one and two after spine fusion surgery.

Interventions

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

Also known as: Dexamethasone Sodium Phosphate 1 mL 4 mg/mL

Corticosteroid

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Prednisone; dexamethasone 21-phosphate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jung U Yoo, MD

  Department of Orthopaedics and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Spencer J Smith, BS

CONTACT

503-828-7136; smithsp@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized into one of two groups: treatment group vs control (no treatment) group

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 29, 2020
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)