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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ülkü Sabuncu, Assoc Prof
- 전화번호: 905337085212
- 이메일: sabuncuulku@gmail.com
연구 장소
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06680
- Ankara Bilkent City Hospital
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연락하다:
- Ülkü Sabuncu, Assoc Prof
- 전화번호: 905337085212
- 이메일: sabuncuulku@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Meaningful Pain Response
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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NRS24
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Perioperative/Periprocedural
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Procedure-related adverse events and complications.
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Perioperative/Periprocedural
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 123456 (Innovate UK)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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