Effect of RECK in Posterior Spinal Fusion

Degenerative Disc Disease Clinical Trial

Official title:

Effect of Local Injectable Ropivacaine, Epinephrine, Clonidine, and Ketorolac (RECK) Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447194
• Other study ID #: HP-00109268
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2025
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: Jake Carbone, BS
• Phone: 4436325426
• Email: johncarbone[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: April 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Disease
• Degenerative Lumbar Spinal Stenosis
• Degenerative Spondylolisthesis
• Intervertebral Disc Degeneration
• Spinal Stenosis
• Spondylolisthesis

Intervention

Drug:
• Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail
Please refer to description for interventional group.

Other:
• Placebo
100mL paraspinal normal saline injection intraoperatively, once.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)
Secondary	Opioid Utilization	Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption.	Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days)
Secondary	Hospital Length of Stay	Secondary aims: to investigate of effect of RECK injection on hospital length of stay.	Up to 2 weeks (an average of 4 days)