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

NCT06999993 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-29

No results posted yet for this 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.

Conditions

  • Postdiscectomy Epidural Fibrosis
  • Pain

Interventions

DRUG

Sodium hyaluronate jell

sodium hyaluronate gel was used to decrease or prevent tissue lyres adhesion after surgery

DRUG

Sodium Bicarbonate

sodium bicarbonate decreases tissue acidosis and so it decreases fibrosis

DRUG

Saline

saline 0.9% is a placebo

Sponsors & Collaborators

  • Misr University for Science and Technology

    lead OTHER

Principal Investigators

  • Mohammed Hany Kamal, prof. of anesthesia · Misr University for Science and Technology (MUST)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06999993 on ClinicalTrials.gov