Effect of RECK in Posterior Spinal Fusion

NCT06447194 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: HP-00109268
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Lumbar Spinal Stenosis; Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Disease

Keywords

Spine Surgery; Lumbar Fusion; Pain Control; Opioid Utilization; Local Anesthesia; RECK; R.E.C.K.; Ropivacaine; Epinephrine; Clonidine; Ketorolac; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Opioid Utilization

  Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days)

• Hospital Length of Stay

  Up to 2 weeks (an average of 4 days)

Study Arms (2)

Intervention (RECK)

EXPERIMENTAL

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

Control Group (Placebo)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail DRUG

Please refer to description for interventional group.

Also known as: RECK

Intervention (RECK)

Placebo OTHER

100mL paraspinal normal saline injection intraoperatively, once.

Control Group (Placebo)

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-88 years old
• Undergoing spinal fusion at 1-3 lumbar levels via a posterior approach.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Agnosia

Interventions

Ropivacaine; Epinephrine; Clonidine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded by investigational drug service
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Orthopaedics

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 7, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)