RECK Injection for Spine Surgery Pain

Overseen By Steven C Ludwig, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Maryland, Baltimore

Disqualifiers: Revision surgeries, Trauma, Tumor, Infection, others

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative

72 Participants Needed

What You Need to Know Before You Apply

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the RECK injection treatment differ from other spine surgery pain treatments?

The RECK injection for spine surgery pain is unique because it may involve a novel combination of ingredients or a different mechanism of action compared to traditional treatments like corticosteroid injections or opioid-based pain management. While traditional methods focus on reducing inflammation or blocking pain signals, RECK might offer a new approach, potentially involving regenerative medicine techniques, which aim to repair and regenerate damaged tissues. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the RECK anesthetic cocktail or a placebo injection intraoperatively

Intraoperative

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for VAS pain scores and opioid consumption during hospital stay

4 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RECK

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.

How Is the Trial Designed?

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+

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Steroid injections: effect on pain of spinal origin. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Perioperative Pain Management in Pediatric Spine Surgery. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Perioperative multimodal analgesic injection for patients with adolescent idiopathic scoliosis undergoing posterior spinal fusion surgery. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Regenerative Medicine for Axial and Radicular Spine-Related Pain: A Narrative Review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Radicular pain in post lumbar surgery syndrome: the significance of transforaminal injection of steroids. [2013]