Clinical trial NCT05058287: Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression
Official title: Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Opioid Use
Lumbar Spinal Stenosis
Pain, Postoperative
Pain, Back
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid use total [Both Groups]
timeFrame: In hospital, pre-discharge
measure: Opioid use total [Both Groups]
timeFrame: Every day for 14 days post- discharge
measure: Opioid consumption [Both Groups]
timeFrame: 6-Week Post-Op
measure: Opioid consumption [Both Groups]
timeFrame: 3-Months Post-Op
Secondary outcomes:
measure: Numeric Rating Pain Scale [Both Groups]
timeFrame: pre-operative
measure: Numeric Rating Pain Scale [Both Groups]
timeFrame: every day for 14 days post-op
measure: Numeric Rating Pain Scale [Both Groups]
timeFrame: 6-week
measure: Numeric Rating Pain Scale [Both Groups]
timeFrame: 3-month follow up
measure: Veterans Rand 12-Item Health Survey [Both Groups]
timeFrame: pre-operative
measure: Veterans Rand 12-Item Health Survey [Both Groups]
timeFrame: 2 week post-op
measure: Veterans Rand 12-Item Health Survey [Both Groups]
timeFrame: 6 week post-op
measure: Veterans Rand 12-Item Health Survey [Both Groups]
timeFrame: 3 month post-op
measure: Oswestry Low Back Pain Disability Questionnaire [Both Groups]
timeFrame: pre-operative
measure: Oswestry Low Back Pain Disability Questionnaire [Both Groups]
timeFrame: 2 week
measure: Oswestry Low Back Pain Disability Questionnaire [Both Groups]
timeFrame: 6 week
measure: Oswestry Low Back Pain Disability Questionnaire [Both Groups]
timeFrame: 3 month follow up
measure: Return to Work [Both Groups]
timeFrame: 2 week
measure: Return to Work [Both Groups]
timeFrame: 6 week
measure: Return to Work [Both Groups]
timeFrame: 3 month follow up
measure: Medical Complications [Both Groups]
timeFrame: 2 week
measure: Medical Complications [Both Groups]
timeFrame: 6 week
measure: Medical Complications [Both Groups]
timeFrame: 3 month follow up
measure: Re-admissions [Both Groups]
timeFrame: 2 Week
measure: Re-admissions [Both Groups]
timeFrame: 6 Week
measure: Re-admissions [Both Groups]
timeFrame: 3 Month
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References: