Efficacy and Safety of Sodium Hyaluronate Gel Combined With Sodium Bicarbonate Versus Sodium Bicarbonate Alone in Prevention of Failed Back Surgery Syndrome
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.
Timeline
- Start
- 2025-06-20
- Primary completion
- 2026-05-31
- Completion
- 2026-05-31
Publications
- Background Guyer RD, Patterson M, Ohnmeiss DD. Failed back surgery syndrome: diagnostic evaluation. J Am Acad Orthop Surg. 2006 Sep;14(9):534-43. doi: 10.5435/00124635-200609000-00003.
- Background Epter RS, Helm S 2nd, Hayek SM, Benyamin RM, Smith HS, Abdi S. Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome. Pain Physician. 2009 Mar-Apr;12(2):361-78.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Hyaluronate | Other / unclassified | 2 ml | Topical |
| Subject | sodium bicarbonate | Diagnostic / imaging agent | 2 ml | Topical |
Indications
No indication recorded.