RECK Injection for Spine Surgery Pain

Overseen By Steven C Ludwig, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Maryland, Baltimore

Trial Summary

What is the purpose of this trial?

"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.

Eligibility Criteria

This trial is for individuals undergoing posterior spinal fusion who have conditions like degenerative disease, various forms of spondylolisthesis, or spinal stenosis. The study will include those eligible based on specific inclusion criteria and exclude anyone not meeting these standards.

Inclusion Criteria

I am having a back surgery to fuse 1-3 bones in my lower spine.

I am between 18 and 88 years old.

Exclusion Criteria

I have had surgery for injury, cancer, or infection.

I have a history of serious liver, kidney, heart, or mental health issues.

Known hypersensitivity to any of the RECK components

Treatment Details

Interventions

• RECK (Local Anesthetic)

Trial Overview The trial tests the effect of a pain control cocktail named RECK—comprising Ropivacaine, Epinephrine, Clonidine, and Ketorolac—against a placebo in managing postoperative pain and reducing opioid use after surgery.

Participant Groups

Group I: Intervention (RECK) Experimental Treatment 1 Intervention

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.

Group II: Control Group (Placebo) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+