A Phase 3 interventional study of Depo-Medrol 40Mg/Ml Suspension for Injection and Placebo in Opioid Use, Lumbar Spinal Stenosis and Pain, Postoperative, sponsored by Hospital for Special Surgery, New York. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Hospital for Special Surgery, New York · Phase 3, Interventional, and Treatment
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.
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Depo-Medrol 40Mg/Ml Suspension for Injection
Drug: Placebo
Drug page: Methylprednisolone Acetate
40mg Depo-Medrol mixed with hemostatic matrix
1 mL of sterile normal saline mixed with hemostatic matrix
Opioid use total [Both Groups]
Number \& dose of opioid taken converted to oral morphine equivalents post-operatively in hospital
Time frame: In hospital, pre-discharge
Opioid use total [Both Groups]
Number \& dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge
Time frame: Every day for 14 days post- discharge
Opioid consumption [Both Groups]
Is participant still taking post-op opioids
Time frame: 6-Week Post-Op
Opioid consumption [Both Groups]
Is participant still taking post-op opioids
Time frame: 3-Months Post-Op
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
Time frame: 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;
Time frame: 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
Time frame: 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
Time frame: 3-month follow up
Veterans Rand 12-Item Health Survey [Both Groups]
Baseline pain as measured through VR-12
Time frame: pre-operative
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Time frame: 2 week post-op
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Time frame: 6 week post-op
Veterans Rand 12-Item Health Survey [Both Groups]
Change in baseline pain as measured through VR-12
Time frame: 3 month post-op
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Baseline pain as measured through ODI
Time frame: pre-operative
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Time frame: 2 week
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Time frame: 6 week
Oswestry Low Back Pain Disability Questionnaire [Both Groups]
Change in baseline pain as measured through ODI
Time frame: 3 month follow up
Return to Work [Both Groups]
Date participant returned to work
Time frame: 2 week
Return to Work [Both Groups]
Date participant returned to work
Time frame: 6 week
Return to Work [Both Groups]
Date participant returned to work
Time frame: 3 month follow up
Medical Complications [Both Groups]
Any medical complications
Time frame: 2 week
Medical Complications [Both Groups]
Any medical complications
Time frame: 6 week
Medical Complications [Both Groups]
Any medical complications
Time frame: 3 month follow up
Re-admissions [Both Groups]
Any re-admissions
Time frame: 2 Week
Re-admissions [Both Groups]
Any re-admissions
Time frame: 6 Week
Re-admissions [Both Groups]
Any re-admissions
Time frame: 3 Month
Plan to share: Yes — We plan to share de-identified data after all study related activities are completed.
Supporting information: Clinical study report
Time frame: We plan to share de-identified data after all study related activities are completed for a minimum of 1 year.
Access criteria: The data will be posted through PRS
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Studies of the drug tested here: Methylprednisolone Acetate
Hospital for Special Surgery, New York →