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

• Status: ACTIVE_NOT_RECRUITING
• Trial end date: 2026-05-31

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.

• Phase: PHASE2

Details

• Lead Sponsor: Misr University for Science and Technology
• Treatments: Injections; orthovisc; Sodium Bicarbonate; Sodium Chloride; Solutions