Steroids After Spine Fusion Surgery

Postoperative Steroids and Recovery After Spine Fusion

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Fusion
• Intervention / Treatment: Drug: Prednisone 20 Mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Spencer J Smith, BS; Phone Number: 503-828-7136; Email: smithsp@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
      • Contact: Spencer J Smith, BS; Phone Number: 503-828-7136; Email: smithsp@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corticosteroid; 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; 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; Other Names: Dexamethasone Sodium Phosphate 1 mL 4 mg/mL
No Intervention: Control; Participants in this group will receive no steroids on postoperative day one and two after spine fusion surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Jung U Yoo, MD, Department of Orthopaedics and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 6, 2026

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Estimated): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Prednisone; Dexamethasone 21-phosphate
• Other Study ID Numbers: STUDY00021169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes