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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Grade of postoperative epidural fibrosis — one year (20/06/2025 to 31/05/2026)
  ● Grade of epidural fibrosis: as measured by lumbar MRI with contrast at 3 and 6 months after surgery compared with the preoperative lumber MRI.

Trial sites (1)

More Misr University for Science and Technology trials in Egypt

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