Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease

December 15, 2021 updated by: Ghada Mohammed AboelFadl, Assiut University

Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease: a Randomized Controlled Trial

Disc degeneration is a natural part of growing older. Up to 60% of asymptomatic people have MRI findings that are positive. As a result, MRI only provides morphological information and may not be able to determine the clinical significance of the findings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many authors believe that patients who suffer from cervical radiculopathy as a result of degenerative disease and have multilevel pathology on imaging studies still have moderate surgical outcomes. This occurs due to a misdiagnosis or the need to perform surgery on multiple levels despite a single painful lesion.

Although the complication rate for 1- and 2-level ACDF is so low that it is considered one of the safest procedures in spine surgery. There is concern that increasing levels of fusion will lead to more complications, such as a higher incidence of persistent axial neck pain, dysphagia, and vertebral artery injury, as well as more postoperative pain and higher narcotic dosages.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 715715
        • Assiut governorate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients presented with unilateral brachialgia due to multilevel cervical disc disease

Exclusion Criteria:

  • multilevel cervical disc disease who had bilateral brachialgia,
  • myelopathy, double crush syndrome,
  • ossified posterior longitudinal ligament (OPLL),
  • combined anterior and posterior pathology requiring posterior decompression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group C
selective anterior cervical discectomy and fusion (ACDF)
Procedure: selective anterior cervical discectomy and fusion (ACDF)
selective anterior cervical discectomy and fusion (ACDF)
Experimental: Group SNRB
US-guided selective nerve root block (SNRB) then selective anterior cervical discectomy and fusion (ACDF)
Procedure: SNRB+ selective anterior cervical discectomy and fusion (ACDF)
US-guided selective nerve root block (SNRB) + selective anterior cervical discectomy and fusion (ACDF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: 24 hours postoperative
Visual analogue score (VAS): 0= no pain, 10= worst pain
24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 17300111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Selective Nerve Root Block

Clinical Trials on selective anterior cervical discectomy and fusion (ACDF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe