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

NCT06999993 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2022/0098
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Keywords

Sodium hyaluronate jell; Epidural fibrosis; Sodium bicarbonate; Failed Back Surgery Syndrome (FBSS)

Outcome Measures

Primary Outcomes (1)

• Grade of postoperative epidural fibrosis

  ● Grade of epidural fibrosis: as measured by lumbar MRI with contrast at 3 and 6 months after surgery compared with the preoperative lumber MRI.

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

Secondary Outcomes (3)

• Chronic postoperative pain

  Measured at 3 and 6 months after surgery

• Risk of complications from this technique

  From time of surgery to end of 6 months after surgery

• Patient and doctor satisfaction with surgical results

  From time of surgery till 6 months after surgery

Study Arms (3)

Group A (SH): (Sodium Hyaluronate Gel and Sodium Bicarbonate) (n=20)

EXPERIMENTAL

The surgeon will spray the surgical field with 10ml syringe containing 2 ml Sodium Bicarbonate (8.4%), 4 ml Bupivacaine 0.5% and 4ml lidocaine 2%. After that the surgeon will inject Sodium Hyaluronate Gel prefilled syringe (Orthovisc 15mg/ml, 2ml syringe. Anika therapeutics, Inc. 32Wiggins Avenue. Bedford, MA 01730 USA) on the surface of the Dura and the nerve roots before wound closure.

Drug: Sodium hyaluronate jell; Drug: Sodium Bicarbonate

Group B (SB): (Sodium Bicarbonate) (n=20)

ACTIVE COMPARATOR

The surgeon will spray the surgical field with 10 ml syringe containing 2ml Sodium Bicarbonate (8.4%), 4ml Bupivacaine 0.5% and 4ml lidocaine 2% on the surface of the Dura and the nerve roots before wound closure.

Drug: Sodium Bicarbonate

Group C (control) (n=20)

PLACEBO COMPARATOR

The surgeon will spray the surgical field with 10ml syringe containing 4ml Bupivacaine 0.5%, 4ml lidocaine 2% and 2ml of saline 0.9% on the surface of the Dura and the nerve roots before wound closure.

Drug: Saline

Interventions

Sodium hyaluronate jell DRUG

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

Also known as: Orthovisc

Group A (SH): (Sodium Hyaluronate Gel and Sodium Bicarbonate) (n=20)

Sodium Bicarbonate DRUG

sodium bicarbonate decreases tissue acidosis and so it decreases fibrosis

Also known as: Sodium bicarbonate 8.4% Solution for Injection

Group A (SH): (Sodium Hyaluronate Gel and Sodium Bicarbonate) (n=20); Group B (SB): (Sodium Bicarbonate) (n=20)

Saline DRUG

saline 0.9% is a placebo

Also known as: saline 0.9%

Group C (control) (n=20)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Souad Kafafi University Hospital (SKUH), faculty of medicine, Misr University for Science and Technology (MUST)

Giza, Giza Governorate, 15525, Egypt

Location

Related Publications (2)

• 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.

  PMID: 16959891 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.

  PMID: 19305485 BACKGROUND

MeSH Terms

Conditions

Pain; Failed Back Surgery Syndrome

Interventions

orthovisc; Sodium Bicarbonate; Solutions; Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Back Pain

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Mohammed Hany Kamal, prof. of anesthesia

  Misr University for Science and Technology (MUST)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the above selected groups are blind regarding the selected intervention drug for each participant
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthesia & pain

Model Details: Three parallel groups to compare the effects of different drugs on postdiscectomy epidural fibroses and postoperative pain for 6 months period after surgery

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01/06/2025 to 31/05/2026
• Access Criteria: Researchers: Who: Academic researchers, industry scientists, and regulatory agencies. What: Full IPD, including demographic data, treatment assignments, and outcome measures. How: Through data sharing platforms or repositories after submitting a research proposal and obtaining necessary approvals. Regulatory Authorities: Who: Agencies like the FDA or EMA. What: Full IPD and supporting documentation for oversight and review. How: Direct access during the review process of clinical trial applications. Data Sharing Initiatives: Who: Collaborating institutions and consortia. What: Aggregated or anonymized IPD for meta-analyses or systematic reviews. How: Via established partnerships and shared databases. Public and Patient Advocacy Groups: Who: Organizations seeking to promote transparency. What: Summary data and aggregated results, but not individual-level data. How: Through publicly available reports or dashboards.

Locations

EG (1)