- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07595406
Cervical Medial Branch Block Versus Ipsilateral Cervical Erector Spinae Plane Block (CERVESP)
Ultrasound-Guided Cervical Medial Branch Block Versus Ipsilateral Cervical Erector Spinae Plane Block in Cervical Facetogenic Pain: A Prospective Randomized Controlled Study
This prospective randomized controlled study aims to compare the analgesic effectiveness of ultrasound-guided cervical medial branch block and ipsilateral cervical erector spinae plane block in patients with cervical facetogenic pain.
Patients with chronic cervical facet-mediated pain will be randomized into two intervention groups. Pain intensity, functional status, meaningful pain response rates, analgesic consumption, and patient satisfaction will be evaluated during follow-up.
The primary objective is to determine whether cervical erector spinae plane block provides comparable short-term pain relief to cervical medial branch block.
Study Overview
Status
Detailed Description
Cervical facet joints are an important source of chronic axial neck pain. Diagnostic cervical medial branch block is commonly used to identify facet-mediated pain and may also provide short-term analgesic benefit. However, this procedure requires precise targeting of the cervical medial branches and may be technically demanding in some patients.
The cervical erector spinae plane block is an ultrasound-guided interfascial plane block that may provide analgesia through cranio-caudal spread of local anesthetic along the paraspinal fascial plane. Although it has been increasingly used for perioperative and chronic pain indications, its role in cervical facetogenic pain has not been clearly established.
This study will compare the short-term analgesic effectiveness of ultrasound-guided cervical medial branch block and ipsilateral cervical erector spinae plane block in patients with clinically suspected cervical facetogenic pain. Eligible patients will be randomized to receive one of the two ultrasound-guided interventions. Pain intensity, functional disability, meaningful pain response, analgesic use, patient satisfaction, and procedure-related adverse events will be assessed during follow-up.
The study is designed to determine whether cervical erector spinae plane block can provide clinically meaningful pain relief comparable to cervical medial branch block in this patient population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ülkü Sabuncu, Assoc Prof
- Phone Number: 905337085212
- Email: sabuncuulku@gmail.com
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye), 06680
- Ankara Bilkent City Hospital
-
Contact:
- Ülkü Sabuncu, Assoc Prof
- Phone Number: 905337085212
- Email: sabuncuulku@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 80 years
- Chronic neck pain lasting at least 3 months
- Clinical findings suggestive of cervical facetogenic pain
- Numeric Rating Scale pain score ≥4
- Ability to provide informed consent
Exclusion Criteria:
- Cervical radiculopathy or myelopathy
- Major neurological deficit
- Infection at the injection site
- Coagulopathy or anticoagulant therapy contraindicating intervention
- Allergy to local anesthetics
- Pregnancy
- Previous cervical interventional pain procedure within the last 3 months
- Severe psychiatric disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cervical Medial Branch Block
Ultrasound-guided cervical medial branch block will be performed at the clinically suspected symptomatic cervical facet levels.
|
Ultrasound-guided cervical medial branch block performed at clinically suspected symptomatic cervical facet levels using local anesthetic for diagnostic and analgesic purposes.
|
|
Experimental: Cervical Erector Spinae Plane Block
Ultrasound-guided ipsilateral cervical erector spinae plane block will be performed at the symptomatic cervical level. I |
Ultrasound-guided ipsilateral cervical erector spinae plane block performed at the symptomatic cervical level using local anesthetic for analgesic purposes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Meaningful Pain Response
Time Frame: Time Frame: 1 hour after the procedure
|
Proportion of patients achieving at least 50% reduction in Numeric Rating Scale (NRS) pain score during the early post-procedural period.
|
Time Frame: 1 hour after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NRS24
Time Frame: at 24 Hours
|
Change in pain intensity measured using the 11-point Numeric Rating Scale (0=no pain, 10=worst imaginable pain).
|
at 24 Hours
|
|
NRS1
Time Frame: 1 week after the procedure
|
Change in pain intensity measured using the 11-point Numeric Rating Scale.(
0=no pain, 10=worst imaginable pain)
|
1 week after the procedure
|
|
NDI
Time Frame: Baseline and 1 week after the procedure
|
Functional disability associated with neck pain assessed using the Neck Disability Index.0 = no disability 50 = complete disability Higher scores indicate greater neck-related functional disability (worse outcome). |
Baseline and 1 week after the procedure
|
|
GPE
Time Frame: 1 week after the procedure
|
Patient-reported global improvement evaluated using a 7-point Global Perceived Effect scale. The GPE scale ranges from -5 to +5, where: -5 = vastly worse 0 = no change +5 = completely recovered |
1 week after the procedure
|
|
Analgesic Consumption
Time Frame: 24 hours and 1 week after the procedure
|
Need for rescue analgesic medication after the procedure.
|
24 hours and 1 week after the procedure
|
|
Patient Satisfaction
Time Frame: 1 week after the procedure
|
Patient satisfaction regarding the procedure.
|
1 week after the procedure
|
|
Complications
Time Frame: Perioperative/Periprocedural
|
Procedure-related adverse events and complications.
|
Perioperative/Periprocedural
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 123456 (Innovate UK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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