Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04568837

Steroids After Spine Fusion Surgery

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Spine Fusion

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location contact

Spencer J Smith, BS

CONTACT

[email protected]

503-828-7136

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Dexamethasone Sodium Phosphate 1 mL 4 mg/mL

Primary outcomes

  1. Morphine equivalent pain medication use over the length of hospitalization

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

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

  2. Length of hospital stay after surgery

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

    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.

  3. Time to first bowel movement in hospital after surgery

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

    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.

  4. Number of major complications reported during hospital stay after surgery

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

    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.

  5. Morphine equivalent pain medication use over the first 48 hours of hospitalization

    Time frame: From postoperative admission to 48 hours after

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

Study contacts

Contact information is provided by the study sponsor or research team.

Spencer J Smith, BS

CONTACT

[email protected]

503-828-7136

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Postoperative Steroids and Recovery After Spine Fusion

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2020
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.