A Phase 1/2 interventional study of Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail and Placebo in Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease and Degenerative Spondylolisthesis, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 88 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by University of Maryland, Baltimore · Phase 1/2, Interventional, and Treatment
"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.
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.
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Exclusion Criteria:
The arm of patients who will be administered "RECK" local anesthesia cocktail: Ropivacaine 0.125g Clonidine 80 mcg Epinephrine 0.5 mg Ketorolac 30 mg In sterile water 73 mL (total volume of compound is 100 mL) Given through paraspinal muscle injection once intraoperatively.
Drug: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail
The arm of patients who will be administered a placebo injection: 100 mL Normal Saline Given through paraspinal muscle injection once intraoperatively.
Other: Placebo
Please refer to description for interventional group.
Also known as: RECK
100mL paraspinal normal saline injection intraoperatively, once.
Postoperative VAS Pain Scores
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.
Time frame: 2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)
Opioid Utilization
Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption.
Time frame: Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days)
Hospital Length of Stay
Secondary aims: to investigate of effect of RECK injection on hospital length of stay.
Time frame: Up to 2 weeks (an average of 4 days)
Plan to share: No
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University of Maryland, Baltimore