Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Sodium Hyaluronate Gel Combined With Sodium Bicarbonate Versus Sodium Bicarbonate Alone in Prevention of Failed Back Surgery Syndrome
Lead Sponsor:
Misr University for Science and Technology
Conditions:
Postdiscectomy Epidural Fibrosis
Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief 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 ep...
Detailed Description
Hypothesis: We hypothesize that Sodium Hyaluronate Jell combined with Sodium Bicarbonate provides a safer and more efficient barrier in preventing Postoperative adhesions in spine surgery than sprayi...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06999993
Start Date
June 20 2025
End Date
May 31 2026
Last Update
July 29 2025
Active Locations (1)
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1
Souad Kafafi University Hospital (SKUH), faculty of medicine, Misr University for Science and Technology (MUST)
Giza, Giza Governorate, Egypt, 15525