Selective Nerve Root BlockPhase 2/3NCT05145530
Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease
A Phase 2/3 study testing selective anterior cervical discectomy and fusion (ACDF) and SNRB+ selective anterior cervical discectomy and fusion (ACDF) in people with Selective Nerve Root Block and Selective Discectomy, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Selective Nerve Root Block, Selective Discectomy
- What is being tested?
- selective anterior cervical discectomy and fusion (ACDF) and SNRB+ selective anterior cervical discectomy and fusion (ACDF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2017to 30 Apr 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients presented with unilateral brachialgia due to multilevel cervical disc disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Selective Nerve Root Block, Selective Discectomy
- Being tested
- selective anterior cervical discectomy and fusion (ACDF), SNRB+ selective anterior cervical discectomy and fusion (ACDF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective anterior cervical discectomy and fusion (ACDF)Procedure or surgery
selective anterior cervical discectomy and fusion (ACDF)
SNRB+ selective anterior cervical discectomy and fusion (ACDF)Procedure or surgery
US-guided selective nerve root block (SNRB) + selective anterior cervical discectomy and fusion (ACDF)
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | selective anterior cervical discectomy and fusion (ACDF) Receives: Procedure: selective anterior cervical discectomy and fusion (ACDF) |
| Group SNRB | Experimental | US-guided selective nerve root block (SNRB) then selective anterior cervical discectomy and fusion (ACDF) Receives: Procedure: SNRB+ selective anterior cervical discectomy and fusion (ACDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Visual analogue score (VAS): 0= no pain, 10= worst pain
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start10 Aug 2017
- Primary completion30 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Selective Nerve Root BlockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145530
- Sponsor's protocol ID
- 17300111
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30560028McClure 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.
PubMed 33036003Ross 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.
PubMed 27054454
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05145530
- Acronym / sponsor ID
- 17300111
- Conditions
- Selective Nerve Root Block, Selective Discectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Procedure: selective anterior cervical discectomy and fusion (ACDF)selective anterior cervical discectomy and fusion (ACDF) |
| Group SNRB | Experimental | Procedure: SNRB+ selective anterior cervical discectomy and fusion (ACDF)US-guided selective nerve root block (SNRB) then selective anterior cervical discectomy and fusion (ACDF) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients presented with unilateral brachialgia due to multilevel cervical disc disease
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective anterior cervical discectomy and fusion (ACDF)selective anterior cervical discectomy and fusion (ACDF) | Procedure or surgery | Group C |
| SNRB+ selective anterior cervical discectomy and fusion (ACDF)US-guided selective nerve root block (SNRB) + selective anterior cervical discectomy and fusion (ACDF) | Procedure or surgery | Group SNRB |
Primary outcome
pain intensity
Time frame: 24 hours postoperative
Visual analogue score (VAS): 0= no pain, 10= worst pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Background: PubMed 30560028Kreitz 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.
- Background: PubMed 33036003McClure 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.
- Background: PubMed 27054454Ross 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing selective anterior cervical discectomy and fusion (ACDF) and SNRB+ selective anterior cervical discectomy and fusion (ACDF) in people with Selective Nerve Root Block and Selective Discectomy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05145530, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.