Opioid UsePhase 3NCT05058287
Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression
A Phase 3 study testing Depo-Medrol 40Mg/Ml Suspension for Injection in people with Opioid Use and Lumbar Spinal Stenosis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Opioid Use, Lumbar Spinal Stenosis, Pain, Postoperative
- What is being tested?
- Depo-Medrol 40Mg/Ml Suspension for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2021to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo 1 to 2 level laminectomy
- Between the ages of 18-85
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Matthew Cunningham, MD, PhD
About this study
Official title: Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Opioid Use, Lumbar Spinal Stenosis, Pain, Postoperative, Pain, Back
- Being tested
- Depo-Medrol 40Mg/Ml Suspension for Injection, Placebo
- Medical subject headings
- Spinal Stenosis, Pain, Postoperative, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo-Medrol 40Mg/Ml Suspension for InjectionDrug
40mg Depo-Medrol mixed with hemostatic matrix
PlaceboDrug
1 mL of sterile normal saline mixed with hemostatic matrix
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Topical Steroid | Experimental | Not described Receives: Drug: Depo-Medrol 40Mg/Ml Suspension for Injection |
| Group 2: Topical Normal Saline | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use total [Both Groups]
Number \& dose of opioid taken converted to oral morphine equivalents post-operatively in hospital
Measured: In hospital, pre-discharge
Opioid use total [Both Groups]
Number \& dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge
Measured: Every day for 14 days post- discharge
Opioid consumption [Both Groups]
Is participant still taking post-op opioids
Measured: 6-Week Post-Op
Opioid consumption [Both Groups]
Is participant still taking post-op opioids
Measured: 3-Months Post-Op
Secondary outcomes (21)
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
Measured: pre-operative
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;
Measured: every day for 14 days post-op
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
Measured: 6-week
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
Measured: 3-month follow up
Veterans Rand 12-Item Health Survey [Both Groups]
Baseline pain as measured through VR-12
Measured: pre-operative
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Measured: 2 week post-op
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Measured: 6 week post-op
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Measured: 3 month post-op
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Baseline pain as measured through ODI
Measured: pre-operative
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Measured: 2 week
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Measured: 6 week
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Measured: 3 month follow up
Return to Work [Both Groups]
Date participant returned to work
Measured: 2 week
Return to Work [Both Groups]
Date participant returned to work
Measured: 6 week
Return to Work [Both Groups]
Date participant returned to work
Measured: 3 month follow up
Medical Complications [Both Groups]
Any medical complications
Measured: 2 week
Medical Complications [Both Groups]
Any medical complications
Measured: 6 week
Medical Complications [Both Groups]
Any medical complications
Measured: 3 month follow up
Re-admissions [Both Groups]
Any re-admissions
Measured: 2 Week
Re-admissions [Both Groups]
Any re-admissions
Measured: 6 Week
Re-admissions [Both Groups]
Any re-admissions
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start5 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058287
- Sponsor's protocol ID
- 2020-0041
- Status last verified
- Jan 2026
- First submitted
- 9 Aug 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified data after all study related activities are completed.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05058287
- Acronym / sponsor ID
- 2020-0041
- Conditions
- Opioid Use, Lumbar Spinal Stenosis, Pain, Postoperative, Pain, Back
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Topical Steroid | Experimental | Drug: Depo-Medrol 40Mg/Ml Suspension for Injection |
| Group 2: Topical Normal Saline | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo 1 to 2 level laminectomy
- Between the ages of 18-85
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depo-Medrol 40Mg/Ml Suspension for Injection40mg Depo-Medrol mixed with hemostatic matrix | Drug | Group 1: Topical Steroid |
| Placebo1 mL of sterile normal saline mixed with hemostatic matrix | Drug | Group 2: Topical Normal Saline |
Primary outcome
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
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
Opioid consumption [Both Groups]
Time frame: 6-Week Post-Op
Is participant still taking post-op opioids
Opioid consumption [Both Groups]
Time frame: 3-Months Post-Op
Is participant still taking post-op opioids
21 secondary outcomes
Numeric Rating Pain Scale [Both Groups]
Time frame: pre-operative
Numeric Rating Pain Scale [Both Groups]
Time frame: every day for 14 days post-op
Numeric Rating Pain Scale [Both Groups]
Time frame: 6-week
Numeric Rating Pain Scale [Both Groups]
Time frame: 3-month follow up
Veterans Rand 12-Item Health Survey [Both Groups]
Time frame: pre-operative
Veterans Rand 12-Item Health Survey [Both Groups]
Time frame: 2 week post-op
Veterans Rand 12-Item Health Survey [Both Groups]
Time frame: 6 week post-op
Veterans Rand 12-Item Health Survey [Both Groups]
Time frame: 3 month post-op
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Time frame: pre-operative
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Time frame: 2 week
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Time frame: 6 week
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Time frame: 3 month follow up
Return to Work [Both Groups]
Time frame: 2 week
Return to Work [Both Groups]
Time frame: 6 week
Return to Work [Both Groups]
Time frame: 3 month follow up
Medical Complications [Both Groups]
Time frame: 2 week
Medical Complications [Both Groups]
Time frame: 6 week
Medical Complications [Both Groups]
Time frame: 3 month follow up
Re-admissions [Both Groups]
Time frame: 2 Week
Re-admissions [Both Groups]
Time frame: 6 Week
Re-admissions [Both Groups]
Time frame: 3 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Yes. We plan to share de-identified data after all study related activities are completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depo-Medrol 40Mg/Ml Suspension for Injection in people with Opioid Use and Lumbar Spinal Stenosis, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Himo Gang, MPH ((917) 623-5416, gangh@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use total [Both Groups] (time frame: In hospital, pre-discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.