Effect of RECK in Posterior Spinal Fusion

Phase 1

Not yet recruiting

• Conditions: Degenerative Lumbar Spinal Stenosis; Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Disease
• Interventions: Drug: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail; Other: Placebo

• Registration Number: NCT06447194
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07
• Study Start: 2025-04-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (RECK)	Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail	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.
Control Group (Placebo)	Placebo	The arm of patients who will be administered a placebo injection: 100 mL Normal Saline Given through paraspinal muscle injection once intraoperatively.

Primary Outcome Measures

Name	Time	Method
Postoperative VAS Pain Scores	2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)	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.

Secondary Outcome Measures

Name	Time	Method
Opioid Utilization	Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days)	Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption.
Hospital Length of Stay	Up to 2 weeks (an average of 4 days)	Secondary aims: to investigate of effect of RECK injection on hospital length of stay.

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States