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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Topical Steroid | Experimental |
| |
| Group 2: Topical Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depo-Medrol 40Mg/Ml Suspension for Injection | Drug | 40mg Depo-Medrol mixed with hemostatic matrix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid use total [Both Groups] | Number & dose of opioid taken converted to oral morphine equivalents post-operatively in hospital | In hospital, pre-discharge |
| Opioid use total [Both Groups] | Number & dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge | Every day for 14 days post- discharge |
| Opioid consumption [Both Groups] | Is participant still taking post-op opioids | 6-Week Post-Op |
| Opioid consumption [Both Groups] | Is participant still taking post-op opioids | 3-Months Post-Op |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | pre-operative |
| Numeric Rating Pain Scale [Both Groups] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Himo Gang, MPH | Contact | (917) 623-5416 | gangh@hss.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
We plan to share de-identified data after all study related activities are completed.
We plan to share de-identified data after all study related activities are completed for a minimum of 1 year.
The data will be posted through PRS
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D010149 | Pain, Postoperative |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D000077555 | Methylprednisolone Acetate |
| D013535 | Suspensions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| Placebo | Drug | 1 mL of sterile normal saline mixed with hemostatic matrix |
|
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;
| 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 | 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 | 3-month follow up |
| Veterans Rand 12-Item Health Survey [Both Groups] | Baseline pain as measured through VR-12 | pre-operative |
| Veterans Rand 12-Item Health Survey [Both Groups] | Change in baseline pain as measured through VR-12 | 2 week post-op |
| Veterans Rand 12-Item Health Survey [Both Groups] | Change in baseline pain as measured through VR-12 | 6 week post-op |
| Veterans Rand 12-Item Health Survey [Both Groups] | Change in baseline pain as measured through VR-12 | 3 month post-op |
| Oswestry Low Back Pain Disability Questionnaire [Both Groups] | Baseline pain as measured through ODI | pre-operative |
| Oswestry Low Back Pain Disability Questionnaire [Both Groups] | Change in baseline pain as measured through ODI | 2 week |
| Oswestry Low Back Pain Disability Questionnaire [Both Groups] | Change in baseline pain as measured through ODI | 6 week |
| Oswestry Low Back Pain Disability Questionnaire [Both Groups] | Change in baseline pain as measured through ODI | 3 month follow up |
| Return to Work [Both Groups] | Date participant returned to work | 2 week |
| Return to Work [Both Groups] | Date participant returned to work | 6 week |
| Return to Work [Both Groups] | Date participant returned to work | 3 month follow up |
| Medical Complications [Both Groups] | Any medical complications | 2 week |
| Medical Complications [Both Groups] | Any medical complications | 6 week |
| Medical Complications [Both Groups] | Any medical complications | 3 month follow up |
| Re-admissions [Both Groups] | Any re-admissions | 2 Week |
| Re-admissions [Both Groups] | Any re-admissions | 6 Week |
| Re-admissions [Both Groups] | Any re-admissions | 3 Month |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |