Analgesic Efficacy of Ultrasound-guided Inter-semispinal Fascial Plane Block (ISPB) Versus Erector Spinae Plane Block (ESPB) in Posterior Cervical Spine Surgery: A Prospective Randomized Double-Blinded Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The total perioperative opioid consumption
研究概览
简要总结
Recent advances in regional anesthesia techniques have aimed to provide more targeted and effective pain relief. Among these, the erector spinae plane (ESPB) block, the multifidus cervicis plane (MCP) block, and the paraspinal interfascial plane block (PIP) is rapidly expanding in cervical spine surgery. Of these, the inter-semispinal fascial plane block (ISPB) has gained popularity as an analgesic technique for posterior cervical spine surgery also, (ESPB) have been tried successfully for posterior cervical spine surgery in few recent trials. But to our knowledge, no study compared the efficacy of both blocks. So, the current study aimed to compare the analgesic efficacy of inter-semispinal fascial plane block versus erector spinae plane block in patients undergoing elective posterior cervical spine surgery.
详细描述
After approval of the institutional ethics committee, clinicaltrials.gov registration and written informed consent, (102) patients scheduled for elective Posterior Cervical Spine Surgery at Fayoum university hospital from November 2025 until the sample size is fulfilled will be enrolled in this study. This randomized double-blinded clinical trial will be reported following the tenets of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) 2025-updated statement.
Patients will be randomized into two equal groups (1:1 allocation) using a computer-generated random number that will be sealed in a separate opaque envelope opened by an anaesthesiologist, who is responsible for performing the block and will not be involved in patient management or data collection.
For Group (A); an ultrasound-guided bilateral inter-semispinal fascial plane block (ISPB) will be performed.
For Group (B); an ultrasound-guided bilateral erector spinae plane block (ESPB) will be performed.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age or older.
- •Patients Scheduled for Elective Posterior Cervical Spine Surgery.
- •American Society of Anesthesiologists (ASA) physical status I-III.
排除标准
- •Patients with traumatic or emergency surgeries.
- •Renal or hepatic impairment
- •Allergy to drug used.
- •Re-do surgery.
- •Coagulopathy.
- •Neuromuscular disease.
- •Preoperative poor left ventricular function (EF < 35%).
- •Systemic infections or infections at site of injection.
- •Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
- •Narcotic dependency.
- •Exclusion Criteria:
研究组 & 干预措施
Group (A)
an ultrasound-guided bilateral inter-semispinal fascial plane block (ISPB) will be performed and injection of 15 mL Bupivacaine 0.25% on each side
干预措施: Bupivacaine (Drug)
Group (B)
an ultrasound-guided bilateral erector spinae plane block (ESPB) will be performed and injection of 15 mL Bupivacaine 0.25% on each side
干预措施: Bupivacaine (Drug)
结局指标
主要结局
The total perioperative opioid consumption
时间窗: during the first 24 hours postoperatively
the total perioperative opioid consumption through two co-primary outcomes, i.e. total amount of fentanyl administered intraoperatively and total fentanyl consumption during the first 24 hours postoperatively.
次要结局
未报告次要终点
研究者
Mina Mahrous, MD
lecturer of Anesthesiology
Fayoum University