Pain, Postoperative Clinical Trial
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid use total [Both Groups] | Number & dose of opioid taken converted to oral morphine equivalents post-operatively in hospital | In hospital, pre-discharge | |
Primary | 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 | |
Primary | Opioid consumption [Both Groups] | Is participant still taking post-op opioids | 6-Week Post-Op | |
Primary | Opioid consumption [Both Groups] | Is participant still taking post-op opioids | 3-Months Post-Op | |
Secondary | 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 | |
Secondary | 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; | every day for 14 days post-op | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Veterans Rand 12-Item Health Survey [Both Groups] | Baseline pain as measured through VR-12 | pre-operative | |
Secondary | Veterans Rand 12-Item Health Survey [Both Groups] | Change in baseline pain as measured through VR-12 | 2 week post-op | |
Secondary | Veterans Rand 12-Item Health Survey [Both Groups] | Change in baseline pain as measured through VR-12 | 6 week post-op | |
Secondary | Veterans Rand 12-Item Health Survey [Both Groups] | Change in baseline pain as measured through VR-12 | 3 month post-op | |
Secondary | Oswestry Low Back Pain Disability Questionnaire [Both Groups] | Baseline pain as measured through ODI | pre-operative | |
Secondary | Oswestry Low Back Pain Disability Questionnaire [Both Groups] | Change in baseline pain as measured through ODI | 2 week | |
Secondary | Oswestry Low Back Pain Disability Questionnaire [Both Groups] | Change in baseline pain as measured through ODI | 6 week | |
Secondary | Oswestry Low Back Pain Disability Questionnaire [Both Groups] | Change in baseline pain as measured through ODI | 3 month follow up | |
Secondary | Return to Work [Both Groups] | Date participant returned to work | 2 week | |
Secondary | Return to Work [Both Groups] | Date participant returned to work | 6 week | |
Secondary | Return to Work [Both Groups] | Date participant returned to work | 3 month follow up | |
Secondary | Medical Complications [Both Groups] | Any medical complications | 2 week | |
Secondary | Medical Complications [Both Groups] | Any medical complications | 6 week | |
Secondary | Medical Complications [Both Groups] | Any medical complications | 3 month follow up | |
Secondary | Re-admissions [Both Groups] | Any re-admissions | 2 Week | |
Secondary | Re-admissions [Both Groups] | Any re-admissions | 6 Week | |
Secondary | Re-admissions [Both Groups] | Any re-admissions | 3 Month |
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