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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ülkü Sabuncu, Assoc prof
- Numéro de téléphone: 905337085212
- E-mail: sabuncuulku@gmail.com
Lieux d'étude
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Ankara
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Ankara, Ankara, Turquie (Türkiye), 06680
- Ankara Bilkent City Hospital
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Contact:
- Ülkü Sabuncu, Assoc prof
- Numéro de téléphone: 905337085212
- E-mail: sabuncuulku@gmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Cervical Medial Branch Block
Ultrasound-guided cervical medial branch block will be performed at the clinically suspected symptomatic cervical facet levels.
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Ultrasound-guided cervical medial branch block performed at clinically suspected symptomatic cervical facet levels using local anesthetic for diagnostic and analgesic purposes.
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Expérimental: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Meaningful Pain Response
Délai: Time Frame: 1 hour after the procedure
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Proportion of patients achieving at least 50% reduction in Numeric Rating Scale (NRS) pain score during the early post-procedural period.
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Time Frame: 1 hour after the procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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NRS24
Délai: at 24 Hours
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Change in pain intensity measured using the 11-point Numeric Rating Scale (0=no pain, 10=worst imaginable pain).
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at 24 Hours
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NRS1
Délai: 1 week after the procedure
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Change in pain intensity measured using the 11-point Numeric Rating Scale.(
0=no pain, 10=worst imaginable pain)
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1 week after the procedure
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NDI
Délai: Baseline and 1 week after the procedure
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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
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GPE
Délai: 1 week after the procedure
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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
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Analgesic Consumption
Délai: 24 hours and 1 week after the procedure
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Need for rescue analgesic medication after the procedure.
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24 hours and 1 week after the procedure
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Patient Satisfaction
Délai: 1 week after the procedure
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Patient satisfaction regarding the procedure.
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1 week after the procedure
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Complications
Délai: Perioperative/Periprocedural
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Procedure-related adverse events and complications.
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Perioperative/Periprocedural
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Collaborateurs et enquêteurs
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Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 123456 (Innovate UK)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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