Effect of RECK in Posterior Spinal Fusion
NCT06447194 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2025-07-31
Summary
"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following.
Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.
Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay.
Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.
Conditions
- Degenerative Lumbar Spinal Stenosis
- Degenerative Disc Disease
- Degenerative Spondylolisthesis
- Degenerative Disease
Interventions
- DRUG
-
Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail
Please refer to description for interventional group.
- OTHER
-
Placebo
100mL paraspinal normal saline injection intraoperatively, once.
Sponsors & Collaborators
-
University of Maryland, Baltimore
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 88 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2027-01-01
- Completion
- 2027-04-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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