Effect of RECK in Posterior Spinal Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-04-01

Brief Summary

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"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.

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Detailed Description

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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.

Conditions

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Degenerative Lumbar Spinal Stenosis Degenerative Disc Disease Degenerative Spondylolisthesis Degenerative Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blinded by investigational drug service

Study Groups

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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.

Group Type EXPERIMENTAL

Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail

Intervention Type DRUG

Please refer to description for interventional group.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

100mL paraspinal normal saline injection intraoperatively, once.

Interventions

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Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail

Please refer to description for interventional group.

Intervention Type DRUG

Placebo

100mL paraspinal normal saline injection intraoperatively, once.

Intervention Type OTHER

Other Intervention Names

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RECK

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes