Opioid Use, Lumbar Spinal Stenosis, Pain, Postoperative, Pain, Back
Conditions
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.
Interventions
40mg Depo-Medrol mixed with hemostatic matrix
DRUGPlacebo
1 mL of sterile normal saline mixed with hemostatic matrix
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid use total [Both Groups] | In hospital, pre-discharge | Number \& dose of opioid taken converted to oral morphine equivalents post-operatively in hospital |
| Opioid consumption [Both Groups] | 6-Week Post-Op | Is participant still taking post-op opioids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Pain Scale [Both Groups] | pre-operative | Baseline pain as measured through the NRS 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe |
| Veterans Rand 12-Item Health Survey [Both Groups] | pre-operative | Baseline pain as measured through VR-12 |
| Oswestry Low Back Pain Disability Questionnaire [Both Groups] | pre-operative | Baseline pain as measured through ODI |
| Return to Work [Both Groups] | 2 week | Date participant returned to work |
| Medical Complications [Both Groups] | 2 week | Any medical complications |
| Re-admissions [Both Groups] | 2 Week | Any re-admissions |
Countries
United States
Contacts
CONTACTCatherine Himo Gang, MPH
Outcome results
None listed