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NCT Number: NCT05058287

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital for Special Surgery

New York, 10021, United States

Location status: Recruiting

Location contact

Matthew Cunningham, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Depo-Medrol 40Mg/Ml Suspension for Injection

Drug

40mg Depo-Medrol mixed with hemostatic matrix

Placebo

Drug

1 mL of sterile normal saline mixed with hemostatic matrix

Primary outcomes

  1. Opioid use total [Both Groups]

    Time frame: In hospital, pre-discharge

    Number & dose of opioid taken converted to oral morphine equivalents post-operatively in hospital

  2. Opioid use total [Both Groups]

    Time frame: Every day for 14 days post- discharge

    Number & dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge

  3. Opioid consumption [Both Groups]

    Time frame: 6-Week Post-Op

    Is participant still taking post-op opioids

  4. Opioid consumption [Both Groups]

    Time frame: 3-Months Post-Op

    Is participant still taking post-op opioids

Secondary outcomes

  1. Numeric Rating Pain Scale [Both Groups]

    Time frame: pre-operative

    Baseline pain as measured through the NRS 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe

  2. Numeric Rating Pain Scale [Both Groups]

    Time frame: every day for 14 days post-op

    Change in baseline pain as measured through the NRS Scale: 0-10 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe;

  3. Numeric Rating Pain Scale [Both Groups]

    Time frame: 6-week

    Change in baseline pain as measured through the NRS Scale: 0-10 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe

  4. Numeric Rating Pain Scale [Both Groups]

    Time frame: 3-month follow up

    Change in baseline pain as measured through the NRS Scale: 0-10 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe

  5. Veterans Rand 12-Item Health Survey [Both Groups]

    Time frame: pre-operative

    Baseline pain as measured through VR-12

  6. Veterans Rand 12-Item Health Survey [Both Groups]

    Time frame: 2 week post-op

    Change in baseline pain as measured through VR-12

  7. Veterans Rand 12-Item Health Survey [Both Groups]

    Time frame: 6 week post-op

    Change in baseline pain as measured through VR-12

  8. Veterans Rand 12-Item Health Survey [Both Groups]

    Time frame: 3 month post-op

    Change in baseline pain as measured through VR-12

  9. Oswestry Low Back Pain Disability Questionnaire [Both Groups]

    Time frame: pre-operative

    Baseline pain as measured through ODI

  10. Oswestry Low Back Pain Disability Questionnaire [Both Groups]

    Time frame: 2 week

    Change in baseline pain as measured through ODI

  11. Oswestry Low Back Pain Disability Questionnaire [Both Groups]

    Time frame: 6 week

    Change in baseline pain as measured through ODI

  12. Oswestry Low Back Pain Disability Questionnaire [Both Groups]

    Time frame: 3 month follow up

    Change in baseline pain as measured through ODI

  13. Return to Work [Both Groups]

    Time frame: 2 week

    Date participant returned to work

  14. Return to Work [Both Groups]

    Time frame: 6 week

    Date participant returned to work

  15. Return to Work [Both Groups]

    Time frame: 3 month follow up

    Date participant returned to work

  16. Medical Complications [Both Groups]

    Time frame: 2 week

    Any medical complications

  17. Medical Complications [Both Groups]

    Time frame: 6 week

    Any medical complications

  18. Medical Complications [Both Groups]

    Time frame: 3 month follow up

    Any medical complications

  19. Re-admissions [Both Groups]

    Time frame: 2 Week

    Any re-admissions

  20. Re-admissions [Both Groups]

    Time frame: 6 Week

    Any re-admissions

  21. Re-admissions [Both Groups]

    Time frame: 3 Month

    Any re-admissions

Study contacts

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

Catherine Himo Gang, MPH

CONTACT

[email protected]

(917) 623-5416

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 27, 2021
Registry last updated
Apr 28, 2026

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.

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