Effect of RECK in Posterior Spinal Fusion

University of Maryland Baltimore (UMB)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Degenerative Disc Disease; Degenerative Disease; Degenerative Spondylolisthesis; Degenerative Lumbar Spinal Stenosis

Treatments: Drug: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06447194

HP-00109268

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Intervention (RECK)

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail

Control Group (Placebo)

Placebo Comparator group

Description:

The arm of patients who will be administered a placebo injection: 100 mL Normal Saline Given through paraspinal muscle injection once intraoperatively.

Treatment:

Other: Placebo