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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pain relief injection called RECK, which combines four medications, to determine its effectiveness in alleviating pain after spine surgery. Researchers aim to assess whether this injection reduces pain levels, decreases the need for opioids, and shortens hospital stays compared to a placebo (a non-active substance). Candidates include individuals undergoing posterior spinal fusion surgery on 1-3 lumbar levels who do not have certain severe health issues or allergies to the medications. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that RECK injection is likely to be safe for humans?

Research has shown that the RECK injection, used during spinal fusion surgery, can help reduce postoperative pain. It may also lessen the need for strong pain medications like opioids and shorten hospital stays. Although specific safety details from these studies aren't provided, the ingredients in RECK—ropivacaine, epinephrine, clonidine, and ketorolac—are commonly used for pain relief and are generally considered safe. However, as this trial is in its early stages, it primarily focuses on assessing safety and side effects, so complete safety information is still being gathered. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for post-surgery spine pain, which often involve systemic pain medications like opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), RECK offers a localized pain management solution. RECK is a unique cocktail of ropivacaine, clonidine, epinephrine, and ketorolac, delivered directly to the paraspinal muscles during surgery. This targeted delivery method aims to provide effective pain relief right at the source, potentially reducing the need for systemic medications and their associated side effects. Researchers are excited about RECK because it could offer a more efficient and potentially safer way to manage pain after spine surgery.

What evidence suggests that RECK injection might be an effective treatment for spine surgery pain?

In this trial, participants will receive either the RECK injection or a placebo. Research has shown that the RECK injection, which contains Ropivacaine, Epinephrine, Clonidine, and Ketorolac, holds promise for controlling pain after spine surgery. Specifically, studies found that patients who received RECK reported less pain at various times post-surgery. They also required fewer opioid painkillers, a significant advantage given the risks associated with opioids. Additionally, RECK has been linked to shorter hospital stays. This combination appears effective for managing pain and aiding recovery after spinal surgeries. ^{2 4 6 7 8}

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187887502300726X

Ropivacaine-Epinephrine-Clonidine-Ketorolac Cocktail as ... Conclusions. The RECK cocktail has potential to be an effective therapeutic option for the postoperative management of lumbar decompression surgeries.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39662683/

Ropivacaine-epinephrine-clonidine-ketorolac is an ... In patients undergoing posterior spinal fusion, RECK was superior to other local anesthetics as it improved pain control, decreased length-of-stay, and ...

3. thespinejournalonline.com thespinejournalonline.com/article/S1529-9430(24)01205-1/abstract

Ropivacaine-epinephrine-clonidine-ketorolac is an ... Of the 162 patients meeting study criteria, 49 (30.2%) received RECK. RECK was significantly associated with decreased pain levels at 2-, 4-, 6-, and 12-hours ...

4. scholars.duke.edu scholars.duke.edu/individual/pub1597796

Ropivacaine-Epinephrine-Clonidine-Ketorolac Cocktail as a ... CONCLUSIONS: The RECK cocktail has potential to be an effective therapeutic option for the postoperative management of lumbar decompression surgeries. Duke ...

5. trials.arthritis.org trials.arthritis.org/trials/NCT06447194

Effect of RECK in Posterior Spinal Fusion - Clinical Trial Finder RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1529943024012051

Ropivacaine-epinephrine-clonidine-ketorolac is an ... RECK administration during spinal fusion surgery was associated with decreased postoperative pain levels, inpatient opioid utilization, LOS, and chronic opioid ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37263493/

Ropivacaine-Epinephrine-Clonidine-Ketorolac Cocktail as ... Conclusions: The RECK cocktail has potential to be an effective therapeutic option for the postoperative management of lumbar decompression surgeries. Keywords: ...

8. consultant360.com consultant360.com/exclusive/reck-cocktail-reduces-pain-opioid-use-and-hospital-stay-after-posterior-spinal-fusion

RECK Cocktail Reduces Pain, Opioid Use, and Hospital ... The study results showed that RECK use was significantly associated with lower pain scores at 2, 4, 6, and 12 hours postoperatively (P ≤ .001–.01). It was also ...