Effect of RECK in Posterior Spinal Fusion

University of Maryland, Baltimore

Overview

"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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Degenerative Lumbar Spinal Stenosis Degenerative Disc Disease Degenerative Spondylolisthesis Degenerative Disease

Interventions

Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection CocktailDRUG

Please refer to description for interventional group.

PlaceboOTHER

100mL paraspinal normal saline injection intraoperatively, once.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 88 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Maryland Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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