Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Recruiting
CT.gov ID
NCT05058287
Collaborator
(none)
150
1
2
37.8
4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Depo-Medrol 40Mg/Ml Suspension for Injection
  • Drug: Placebo
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial
Actual Study Start Date :
Nov 5, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: Topical Steroid

Drug: Depo-Medrol 40Mg/Ml Suspension for Injection
40mg Depo-Medrol mixed with hemostatic matrix

Placebo Comparator: Group 2: Topical Normal Saline

Drug: Placebo
1 mL of sterile normal saline mixed with hemostatic matrix

Outcome Measures

Primary Outcome Measures

  1. Opioid use total [Both Groups] [In hospital, pre-discharge]

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

  2. Opioid use total [Both Groups] [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] [6-Week Post-Op]

    Is participant still taking post-op opioids

  4. Opioid consumption [Both Groups] [3-Months Post-Op]

    Is participant still taking post-op opioids

Secondary Outcome Measures

  1. Numeric Rating Pain Scale [Both Groups] [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] [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] [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] [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] [pre-operative]

    Baseline pain as measured through VR-12

  6. Veterans Rand 12-Item Health Survey [Both Groups] [2 week post-op]

    Change in baseline pain as measured through VR-12

  7. Veterans Rand 12-Item Health Survey [Both Groups] [6 week post-op]

    Change in baseline pain as measured through VR-12

  8. Veterans Rand 12-Item Health Survey [Both Groups] [3 month post-op]

    Change in baseline pain as measured through VR-12

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

    Baseline pain as measured through ODI

  10. Oswestry Low Back Pain Disability Questionnaire [Both Groups] [2 week]

    Change in baseline pain as measured through ODI

  11. Oswestry Low Back Pain Disability Questionnaire [Both Groups] [6 week]

    Change in baseline pain as measured through ODI

  12. Oswestry Low Back Pain Disability Questionnaire [Both Groups] [3 month follow up]

    Change in baseline pain as measured through ODI

  13. Return to Work [Both Groups] [2 week]

    Date participant returned to work

  14. Return to Work [Both Groups] [6 week]

    Date participant returned to work

  15. Return to Work [Both Groups] [3 month follow up]

    Date participant returned to work

  16. Medical Complications [Both Groups] [2 week]

    Any medical complications

  17. Medical Complications [Both Groups] [6 week]

    Any medical complications

  18. Medical Complications [Both Groups] [3 month follow up]

    Any medical complications

  19. Re-admissions [Both Groups] [2 Week]

    Any re-admissions

  20. Re-admissions [Both Groups] [6 Week]

    Any re-admissions

  21. Re-admissions [Both Groups] [3 Month]

    Any re-admissions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital for Special Surgery New York New York United States 10021

Sponsors and Collaborators

  • Hospital for Special Surgery, New York

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT05058287
Other Study ID Numbers:
  • 2020-0041
First Posted:
Sep 27, 2021
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022