Degenerative Disc Disease, Degenerative Disease, Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Conditions
Keywords
Spine Surgery, Lumbar Fusion, Pain Control, Opioid Utilization, Local Anesthesia, RECK, R.E.C.K., Ropivacaine, Epinephrine, Clonidine, Ketorolac, Randomized Controlled Trial
Brief 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.
Detailed description
Patients will be randomized into two groups. Intraoperatively, they will be given either 1) a 50 mL RECK (ropivacaine, epinephrine, clonidine, and ketorolac) cocktail containing 123 mg ropivacaine, 0.25 mg epinephrine, 0.04 mg clonidine, and 15 mg ketorolac into the paraspinal musculature and subdermal space surrounding the operative site once the fascia is closed (intervention group), or 2) a 50 mL injection of saline (control group). RECK is used for pain control and will be administered by fellowship-trained orthopaedic spine surgeons. All patients will have a patient-controlled analgesia pump initiated shortly after surgery, with routine postoperative care and observation from nurses, pain management, and orthopedic surgeons and residents.
Interventions
DRUGRopivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail
Please refer to description for interventional group.
OTHERPlacebo
100mL paraspinal normal saline injection intraoperatively, once.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded by investigational drug service
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-88 years old * Undergoing spinal fusion at 1-3 lumbar levels via a posterior approach.
Exclusion criteria
* Revision surgeries * Surgeries indicated for trauma, tumor, or infection * Preoperative history of moderate to severe hepatic, renal, cardiac, or psychiatric illness * Known hypersensitivity to any of the RECK components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative VAS Pain Scores | 2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days) | Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores. VAS (Visual Analogue Scale) measures pain intensity. The VAS is a 10cm line with two end points representing 0 (No pain) and 10 (Pain as bad as it could be). The patient is asked to rate their pain by placing a marker on the line. A lower score (thus closer to no pain) is a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Utilization | Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days) | Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption. |
| Hospital Length of Stay | Up to 2 weeks (an average of 4 days) | Secondary aims: to investigate of effect of RECK injection on hospital length of stay. |
Countries
United States
Outcome results
None listed