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

NCT ID: NCT05145530

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Selective Nerve Root Block Selective Discectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Group C

selective anterior cervical discectomy and fusion (ACDF)

Group Type ACTIVE_COMPARATOR

selective anterior cervical discectomy and fusion (ACDF)

Intervention Type PROCEDURE

selective anterior cervical discectomy and fusion (ACDF)

Group SNRB

US-guided selective nerve root block (SNRB) then selective anterior cervical discectomy and fusion (ACDF)

Group Type EXPERIMENTAL

SNRB+ selective anterior cervical discectomy and fusion (ACDF)

Intervention Type PROCEDURE

US-guided selective nerve root block (SNRB) + selective anterior cervical discectomy and fusion (ACDF)

Interventions

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selective anterior cervical discectomy and fusion (ACDF)

selective anterior cervical discectomy and fusion (ACDF)

Intervention Type PROCEDURE

SNRB+ selective anterior cervical discectomy and fusion (ACDF)

US-guided selective nerve root block (SNRB) + selective anterior cervical discectomy and fusion (ACDF)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Kreitz TM, Hollern DA, Padegimas EM, Schroeder GD, Kepler CK, Vaccaro AR, Hilibrand AS. Clinical Outcomes After Four-Level Anterior Cervical Discectomy and Fusion. Global Spine J. 2018 Dec;8(8):776-783. doi: 10.1177/2192568218770763. Epub 2018 Apr 24.

Reference Type BACKGROUND
PMID: 30560028 (View on PubMed)

McClure JJ, Desai BD, Shabo LM, Buell TJ, Yen CP, Smith JS, Shaffrey CI, Shaffrey ME, Buchholz AL. A single-center retrospective analysis of 3- or 4-level anterior cervical discectomy and fusion: surgical outcomes in 66 patients. J Neurosurg Spine. 2020 Oct 9;34(1):45-51. doi: 10.3171/2020.6.SPINE20171. Print 2021 Jan 1.

Reference Type BACKGROUND
PMID: 33036003 (View on PubMed)

Ross DA, Ross MN. Diagnosis and Treatment of C4 Radiculopathy. Spine (Phila Pa 1976). 2016 Dec 1;41(23):1790-1794. doi: 10.1097/BRS.0000000000001620.

Reference Type BACKGROUND
PMID: 27054454 (View on PubMed)

Other Identifiers

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17300111

Identifier Type: -

Identifier Source: org_study_id

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