Active — Not RecruitingPhase 2/3

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

Egypt60 participantsStarted 2025-06-20

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: This study will include patients scheduled for Lumbar Spine surgery (L4-5 and/or L5-S1 Laminectomy) for disc prolapse, Patients aged \>18 years old and below 70 years old and Patients with American Society of Anesthesiologists (ASA) classification I or II. Exclusion Criteria: Patients aged \< 18 years old and above 70 years old, Patients who refuse to participate, Patients on Chronic opioid use (addicts, cancer patients receiving palliative treatment), Patients with ASA classification III or more, Patients with coagulopathy or full anticoagulation, Patients with history of aggressive scar formation, Patients with causes of low back pain other than disc prolapse, Patients with previous lumbar spine surgery and Patients with anemia or acid base disturbances or electrolyte disorders will be excluded from this study. \-

What they're measuring

Grade of postoperative epidural fibrosis

Timeframe: one year (20/06/2025 to 31/05/2026)

Trial details

NCT IDNCT06999993

SponsorMisr University for Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31