Steroids After Spine Fusion Surgery

Oregon Health & Science University (OHSU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Spine Fusion

Treatments: Drug: Prednisone 20 Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04568837

STUDY00021169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Corticosteroid

Experimental group

Description:

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

Treatment:

Drug: Prednisone 20 Mg

Control

No Intervention group

Description:

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