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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ülkü Sabuncu, Assoc prof
- Telefonnummer: 905337085212
- E-post: sabuncuulku@gmail.com
Studieorter
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Ankara
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Ankara, Ankara, Turkiet (Türkiye), 06680
- Ankara Bilkent City Hospital
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Kontakt:
- Ülkü Sabuncu, Assoc prof
- Telefonnummer: 905337085212
- E-post: sabuncuulku@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Meaningful Pain Response
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
NRS24
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Perioperative/Periprocedural
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Procedure-related adverse events and complications.
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Perioperative/Periprocedural
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 123456 (Innovate UK)
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