Clinical Trial

Efficacy and Safety of Sodium Hyaluronate Gel Combined With Sodium Bicarbonate Versus Sodium Bicarbonate Alone in Prevention of Failed Back Surgery Syndrome

Active, Not Recruiting Phase 2/3
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Record status
This record was last updated July 29, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study investigates the efficacy and safety of Sodium Hyaluronate gel combined with Sodium Bicarbonate compared to Sodium Bicarbonate alone in preventing Failed Back Surgery Syndrome (FBSS) and epidural fibrosis after lumbar spine surgery. Will be conducted at Souad Kafafi University Hospital, this randomized controlled trial will involve 60 patients aged 18-70 years scheduled for lumber laminectomy (L4-5 or L5- S1). 60 Patients will be divided into three groups: Group A (n=20) receiving Sodium Hyaluronate and Sodium Bicarbonate , Group B (n=20) receiving Sodium Bicarbonate alone, and Group C (n=20) will be served as the control with saline and local anesthetic. Outcomes will be measured through MRI assessments of epidural fibrosis, pain scores, and satisfaction ratings at 3 and 6 months post-surgery.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-23; most recent amendment 2025-07-24.
Status change: Recruiting → Active, Not Recruiting 2025-07-24
Trial Details
NCT Number NCT06999993
Lead Sponsor Misr University for Science and Technology
Conditions Postdiscectomy Epidural Fibrosis, Pain
Enrollment 60 participants
Start Date 2025-06-20
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-29