NCT04876612

Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection for the Treatment of Lumbar Spinal Stenosis: a Prospective, Double-blind, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Seoul National University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the effects of limaprost(Opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (TFESI) was administered compared to the placebo group.

Detailed description

This study is a prospective, randomized, comparative clinical study that is assigned to a placebo group or a trial group before transforaminal epidural steroid injection (TFESI) is performed. The subjects of the study will receive an explanation of the study and decide to participate voluntarily in patients who have decided to undergo TFESI for neurogenic claudication and low back pain or leg pain due to lumbar spinal canal stenosis (LSS). All study subjects are presented with TFESI at the level appropriate for their symptoms in the operating room and then returned to the recovery room. All participants will be monitored for non-invasive blood pressure, electrocardiography, heart rate, and peripheral oxyven saturation during and after the procedure. Patients assigned to the placebo group will take placebo three times a day and one tablet once from the first day after receiving TFESI. Patients assigned to the trial group will take limaprost (Opalmon®) three times a day, one tablet once from the first day after receiving TFESI. In both groups, the drug was administered for 12 weeks. In both groups, during the first 4 weeks, no drug changes or additional procedures were observed, and only Acetaminophen was allowed as a rescue drug. After TFESI, visits at 4 weeks, 8 weeks and 12 weeks to collect each measurement variable.

Conditions

• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	Transforaminal epidural steroid injection (TFESI)	Well trained pain physician performs all the fluoroscopy-guided transforaminal epidural steroid injection (TFESI), who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For TFESI, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under fluoroscopy guidance at the patient's symptom complaining level. After confirming with a contrast medium, 3 ml of 0.1875% ropivacaine and 5 mg of dexamethasone are administered.

Timeline

• Start date: 2021-11-10
• Primary completion: 2025-06-30
• Completion: 2025-08-31
• First posted: 2021-05-06
• Last updated: 2024-05-29

Locations

1 site across 1 country: South Korea