Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression
Recruiting
Phase 3
Interventional Study
Opioid Use
Lumbar Spinal Stenosis
Pain, Postoperative
Pain, Back
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Hospital for Special Surgery, New York · Other
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About This 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.
Trial Locations
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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.
* Hist…
Contacts