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

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  2. Site details revisedv3
  3. Start date: Jun 1, 2025 to Jun 20, 2025v2 Show 4 more changesShow less
    • Interventions: Saline 0.9% (Drug), Sodium Bicarbonate 8.4% Solution for Injection (Drug), Sodium hyaluronate (Drug) to Saline (Drug), Sodium Bicarbonate (Drug), Sodium hyaluronate jell (Drug)
    • Secondary endpoints reordered
    • Study description expanded, about 950 words
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06999993
Lead Sponsor Misr University for Science and Technology
Conditions
(from sponsor)		 Postdiscectomy Epidural Fibrosis, Pain
Related terms Failed Back Surgery Syndrome, Pain
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov