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NCT06447194 | NOT YET RECRUITING | Degenerative Lumbar Spinal Stenosis

Effect of RECK in Posterior Spinal Fusion
Sponsor:

University of Maryland, Baltimore

Information provided by (Responsible Party):

Steven Ludwig

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.

Condition or disease

Degenerative Lumbar Spinal Stenosis

Degenerative Disc Disease

Degenerative Spondylolisthesis

Degenerative Disease

Intervention/treatment

Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail

Placebo

Phase

PHASE1

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 72 participants
Masking : QUADRUPLE
Masking Description : Double-blinded by investigational drug service
Primary Purpose : TREATMENT
Official Title : Effect of Local Injectable Ropivacaine, Epinephrine, Clonidine, and Ketorolac (RECK) Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2027-01-01
Estimated Study Completion Date : 2027-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 88 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Effect of RECK in Posterior Spinal Fusion

Location Details

NCT06447194

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Locations

Not yet recruiting

United States, Maryland

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201