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

Launched by MISR UNIVERSITY FOR SCIENCE AND TECHNOLOGY · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment that combines Sodium Hyaluronate gel with Sodium Bicarbonate, compared to Sodium Bicarbonate alone, in preventing a condition called Failed Back Surgery Syndrome (FBSS) after lumbar spine surgery. FBSS can occur when scar tissue forms after surgery, leading to pain and other issues. The trial will take place at Souad Kafafi University Hospital and involve 60 patients aged between 18 and 70 who are scheduled for a specific type of back surgery called lumbar laminectomy.

To participate in the trial, candidates must be adults scheduled for lumbar spine surgery due to a bulging disc and must be in good health (classified as ASA I or II). Those who are younger than 18 or older than 70, have certain health conditions, or have had previous spine surgeries will not be eligible. Participants will be randomly placed in one of three groups: one will receive the combination treatment, another will receive only Sodium Bicarbonate, and the third will receive a saline solution with a local anesthetic. Throughout the study, doctors will monitor outcomes like pain levels and patient satisfaction through MRI scans and surveys at 3 and 6 months after surgery. This trial aims to find a better way to prevent pain and complications after back surgery, which could improve recovery for many patients.

Gender

ALL

Eligibility criteria

• 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.
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