Effect of RECK in Posterior Spinal Fusion

July 28, 2025 updated by: Steven Ludwig, University of Maryland, Baltimore

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

"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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (RECK)

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.
Drug: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail
Please refer to description for interventional group.
Other Names:
  • RECK
Placebo Comparator: Control Group (Placebo)

The arm of patients who will be administered a placebo injection:

100 mL Normal Saline

Given through paraspinal muscle injection once intraoperatively.
Other: Placebo
100mL paraspinal normal saline injection intraoperatively, once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative VAS Pain Scores
Time Frame: 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.
2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00109268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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