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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
Sponsor: Misr University for Science and Technology
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.
Official title: Efficacy and Safety of Sodium Hyaluronate Gel Combined With Sodium Bicarbonate Versus Sodium Bicarbonate Alone in Prevention of Failed Back Surgery Syndrome (FBSS)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-06-20
Completion Date
2026-05-31
Last Updated
2025-07-29
Healthy Volunteers
No
Conditions
Interventions
Sodium hyaluronate jell
sodium hyaluronate gel was used to decrease or prevent tissue lyres adhesion after surgery
Sodium Bicarbonate
sodium bicarbonate decreases tissue acidosis and so it decreases fibrosis
Saline
saline 0.9% is a placebo
Locations (1)
Souad Kafafi University Hospital (SKUH), faculty of medicine, Misr University for Science and Technology (MUST)
Giza, Giza Governorate, Egypt