Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis

NCT06684821 | Completed

• 1 other identifier: 36264PR903/10/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.

Conditions

Analgesic Efficacy; Epidural; Neuroplasty; Racz Catheter; Lumbar Fixation; Lumbosacral Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Degree of Disability

  Degree of Disability will be assessed using Oswestry Low Back Disability Questionnaire: This questionnaire has been designed to give us information as to how back pain has affected a patient's ability to manage everyday life. It consists of 10 questions for each question, there is a possible 5 points (0 for the first answer, 1 for the second answer, etc). Add up the total for the 10 questions and rate them on the scale (0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability). It will be assisted pre-procedure as a baseline, after 1, 2, 4, 6 month post-procedure

  6 month post-procedure

Secondary Outcomes (3)

• Degree of pain

  6 month post-procedure

• Degree of patient satisfaction

  6 month post-procedure

• Incidence of complications

  6 month post-procedure

Study Arms (2)

Racz catheter group

EXPERIMENTAL

Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation.

Procedure: Racz catheter

Control group

ACTIVE COMPARATOR

Patients will undergo classic lumber fixation.

Procedure: Classic lumber fixation

Interventions

Racz catheter PROCEDURE

Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation.

Racz catheter group

Classic lumber fixation PROCEDURE

Patients will undergo classic lumber fixation.

Control group

Eligibility Criteria

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

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• Patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica.

You may not qualify if:

• Uncooperative patients.
• Patients in need of discectomy for lumber disc prolapse.
• Patients with severe canal stenosis and in need of spinal laminectomy.
• Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
• Body mass index (BMI) ≥35 kg/m2.
• History of allergy to contrast medium.
• Previously operated traditional spine surgeries.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (1)

• Elhamid ASA, Elsharkawy MS, Shaheen MM, Hamama K, Nada A, Abdelraheem TM. Analgesic Efficacy of Epidural Neuroplasty via Racz Catheter During Lumbar Fixation In Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Jan 6;2026:1031307. doi: 10.1155/anrp/1031307. eCollection 2026.

  PMID: 41503144 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: November 14, 2024
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)