Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- pain intensity
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group C
selective anterior cervical discectomy and fusion (ACDF)
Intervention: selective anterior cervical discectomy and fusion (ACDF) (Procedure)
Group SNRB
US-guided selective nerve root block (SNRB) then selective anterior cervical discectomy and fusion (ACDF)
Intervention: SNRB+ selective anterior cervical discectomy and fusion (ACDF) (Procedure)
Outcomes
Primary Outcomes
pain intensity
Time Frame: 24 hours postoperative
Visual analogue score (VAS): 0= no pain, 10= worst pain
Secondary Outcomes
No secondary outcomes reported
Investigators
Ghada Mohammed AboelFadl
Principal investigator
Assiut University