Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Hospital for Special Surgery (HSS)

Status and phase: Enrolling; Phase 3

Conditions: Pain, Back; Lumbar Spinal Stenosis; Pain, Postoperative; Opioid Use

Treatments: Drug: Placebo; Drug: Depo-Medrol 40Mg/Ml Suspension for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05058287

2020-0041

Details and patient eligibility

About

This study seeks to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1-2 level lumbar laminectomy. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures.

Full description

This is a randomized controlled trial seeking to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1- to 2- level lumbar laminectomies. Subjects enrolled in this study will be randomized to one of two treatments: either 40 mg Depo-Medrol or 1 mL of sterile normal saline will be applied to the surgical wound prior to closure. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures. Subjects will be assessed pre-operatively, while admitted for surgery, and postoperatively daily for two weeks, then again at 1- and 3- months.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled to undergo 1 to 2 level laminectomy
• Between the ages of 18-85

Exclusion criteria

• Minimally invasive surgery
• Prior daily opioid usage within 6 months.
• Use of concomitant procedures such as spinal fusion, revision procedure at the same level.
• History of a chronic pain syndrome, uncontrolled diabetes defined as A1C > 6.5, immunocompromised condition such as active cancer treatment, history of transplant, benign prostatic hyperplasia or history of urinary retention, and other conditions which require chronic steroid therapy or immunosuppressants.
• Non-English speakers
• Patients allergic to Depo-Medrol and/or glucocorticoids, or other steroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 2 patient groups, including a placebo group

Group 1: Topical Steroid

Experimental group

Treatment:

Drug: Depo-Medrol 40Mg/Ml Suspension for Injection

Group 2: Topical Normal Saline

Placebo Comparator group

Treatment:

Drug: Placebo