Clinical trial NCT06447194: Effect of RECK in Posterior Spinal Fusion
Official title: Effect of Local Injectable Ropivacaine, Epinephrine, Clonidine, and Ketorolac (RECK) Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Degenerative Lumbar Spinal Stenosis
Degenerative Disc Disease
Degenerative Spondylolisthesis
Degenerative Disease
Keywords: Spine Surgery
Lumbar Fusion
Pain Control
Opioid Utilization
Local Anesthesia
RECK
R.E.C.K.
Ropivacaine
Epinephrine
Clonidine
Ketorolac
Randomized Controlled Trial
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Postoperative VAS Pain Scores
timeFrame: 2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)
Secondary outcomes:
measure: Opioid Utilization
timeFrame: Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days)
measure: Hospital Length of Stay
timeFrame: Up to 2 weeks (an average of 4 days)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References: