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Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Primary Purpose

Opioid Use, Lumbar Spinal Stenosis, Pain, Postoperative

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Depo-Medrol 40Mg/Ml Suspension for Injection
Placebo
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital for Special SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: Topical Steroid

Group 2: Topical Normal Saline

Arm Description

Outcomes

Primary Outcome Measures

Opioid use total [Both Groups]
Number & dose of opioid taken converted to oral morphine equivalents post-operatively in hospital
Opioid use total [Both Groups]
Number & dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge
Opioid consumption [Both Groups]
Is participant still taking post-op opioids
Opioid consumption [Both Groups]
Is participant still taking post-op opioids

Secondary Outcome Measures

Numeric Rating Pain Scale [Both Groups]
Baseline pain as measured through the NRS 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe
Numeric Rating Pain Scale [Both Groups]
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;
Numeric Rating Pain Scale [Both Groups]
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
Numeric Rating Pain Scale [Both Groups]
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
Veterans Rand 12-Item Health Survey [Both Groups]
Baseline pain as measured through VR-12
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Baseline pain as measured through ODI
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Return to Work [Both Groups]
Date participant returned to work
Return to Work [Both Groups]
Date participant returned to work
Return to Work [Both Groups]
Date participant returned to work
Medical Complications [Both Groups]
Any medical complications
Medical Complications [Both Groups]
Any medical complications
Medical Complications [Both Groups]
Any medical complications
Re-admissions [Both Groups]
Any re-admissions
Re-admissions [Both Groups]
Any re-admissions
Re-admissions [Both Groups]
Any re-admissions

Full Information

First Posted
August 9, 2021
Last Updated
April 20, 2023
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT05058287
Brief Title
Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression
Official Title
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Lumbar Spinal Stenosis, Pain, Postoperative, Pain, Back

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Topical Steroid
Arm Type
Experimental
Arm Title
Group 2: Topical Normal Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Depo-Medrol 40Mg/Ml Suspension for Injection
Intervention Description
40mg Depo-Medrol mixed with hemostatic matrix
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 mL of sterile normal saline mixed with hemostatic matrix
Primary Outcome Measure Information:
Title
Opioid use total [Both Groups]
Description
Number & dose of opioid taken converted to oral morphine equivalents post-operatively in hospital
Time Frame
In hospital, pre-discharge
Title
Opioid use total [Both Groups]
Description
Number & dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge
Time Frame
Every day for 14 days post- discharge
Title
Opioid consumption [Both Groups]
Description
Is participant still taking post-op opioids
Time Frame
6-Week Post-Op
Title
Opioid consumption [Both Groups]
Description
Is participant still taking post-op opioids
Time Frame
3-Months Post-Op
Secondary Outcome Measure Information:
Title
Numeric Rating Pain Scale [Both Groups]
Description
Baseline pain as measured through the NRS 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe
Time Frame
pre-operative
Title
Numeric Rating Pain Scale [Both Groups]
Description
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;
Time Frame
every day for 14 days post-op
Title
Numeric Rating Pain Scale [Both Groups]
Description
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
Time Frame
6-week
Title
Numeric Rating Pain Scale [Both Groups]
Description
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
Time Frame
3-month follow up
Title
Veterans Rand 12-Item Health Survey [Both Groups]
Description
Baseline pain as measured through VR-12
Time Frame
pre-operative
Title
Veterans Rand 12-Item Health Survey [Both Groups]
Description
Change in baseline pain as measured through VR-12
Time Frame
2 week post-op
Title
Veterans Rand 12-Item Health Survey [Both Groups]
Description
Change in baseline pain as measured through VR-12
Time Frame
6 week post-op
Title
Veterans Rand 12-Item Health Survey [Both Groups]
Description
Change in baseline pain as measured through VR-12
Time Frame
3 month post-op
Title
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Description
Baseline pain as measured through ODI
Time Frame
pre-operative
Title
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Description
Change in baseline pain as measured through ODI
Time Frame
2 week
Title
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Description
Change in baseline pain as measured through ODI
Time Frame
6 week
Title
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Description
Change in baseline pain as measured through ODI
Time Frame
3 month follow up
Title
Return to Work [Both Groups]
Description
Date participant returned to work
Time Frame
2 week
Title
Return to Work [Both Groups]
Description
Date participant returned to work
Time Frame
6 week
Title
Return to Work [Both Groups]
Description
Date participant returned to work
Time Frame
3 month follow up
Title
Medical Complications [Both Groups]
Description
Any medical complications
Time Frame
2 week
Title
Medical Complications [Both Groups]
Description
Any medical complications
Time Frame
6 week
Title
Medical Complications [Both Groups]
Description
Any medical complications
Time Frame
3 month follow up
Title
Re-admissions [Both Groups]
Description
Any re-admissions
Time Frame
2 Week
Title
Re-admissions [Both Groups]
Description
Any re-admissions
Time Frame
6 Week
Title
Re-admissions [Both Groups]
Description
Any re-admissions
Time Frame
3 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Knopp, MPH
Phone
(212) 606-1723
Email
knoppr@hss.edu
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Cunningham, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share de-identified data after all study related activities are completed.
IPD Sharing Time Frame
We plan to share de-identified data after all study related activities are completed for a minimum of 1 year.
IPD Sharing Access Criteria
The data will be posted through PRS

Learn more about this trial

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

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