Inter-semispinal Plane (ISP) Block for Postoperative Analgesia Following Cervical Spine Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- postoperative rescue pethidine consumption
研究概览
简要总结
The inter-semispinal plane (ISP) block is a novel ultrasound-guided technique that involves local anesthetic injection into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles with subsequent block of the dorsal rami of the cervical spinal nerves and hence can get adequate postoperative analgesia.
The authors hypothesized that ISP block can reduce the postoperative analgesic consumption in patients undergoing posterior cervical spine surgeries.
The aim of this study is to evaluate the analgesic efficacy of ISP block in patients undergoing posterior cervical spine surgery.
详细描述
This study will be performed in the in the Fayoum University hospital after the local Institutional Ethics Committee and local institutional review board approval. The study design will be double-blind randomized controlled study . A detailed informed consent will be signed by the eligible patients before recruitment and randomization.
Patients were randomly allocated into two groups using computer generated sequence and concealed in sealed opaque envelopes.
Control group (C): patients received general anesthesia only. Inter-semispinal plane (ISP) block group: patients received bilateral ultrasound guided ISP block at the level of C5.
All patients will be assessed Preoperative VAS score then premedicated orally with midazolam 0.5 mg/kg 30 min prior to surgery. All patients were monitored by 5 lead ECG, pulse oximetry, non-invasive blood pressure and capnography and an intravenous (IV) access will be established.
The technique of general anesthesia will be standardized for all patients. General anesthesia will be induced by intravenous (IV) 2 mg/kg propofol and 1 μg/kg fentanyl induction. After IV atracurium 0.5 mg/kg, orotracheal intubation was performed. Anesthesia will be maintained with isoflurane (1.2%-1.5%) in oxygen-air mixture (50%-50%). Muscle relaxation will be maintained during the procedure with atracurium in increments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-II undergoing elective posterior cervical spine surgery
排除标准
- •Patient refusal
- •Patients with any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality)
- •Known allergy to local anesthetics
- •Previous cervical disc surgery or fixation
- •Mental disorders
- •Drug or alcohol abuse.
研究组 & 干预措施
ISP group
patients received bilateral ultrasound guided inter-semispinal plane (ISP) block at the level of C5 using 10 ml of 0.25% bupivacaine and 10ml xylocaine on each side to reduce the toxicity
干预措施: Bupivacaine Hydrochloride (Drug)
ISP group
patients received bilateral ultrasound guided inter-semispinal plane (ISP) block at the level of C5 using 10 ml of 0.25% bupivacaine and 10ml xylocaine on each side to reduce the toxicity
干预措施: Lidocaine Hydrochloride (Drug)
ISP group
patients received bilateral ultrasound guided inter-semispinal plane (ISP) block at the level of C5 using 10 ml of 0.25% bupivacaine and 10ml xylocaine on each side to reduce the toxicity
干预措施: Ultrasound (Device)
ISP group
patients received bilateral ultrasound guided inter-semispinal plane (ISP) block at the level of C5 using 10 ml of 0.25% bupivacaine and 10ml xylocaine on each side to reduce the toxicity
干预措施: Needle (Device)
结局指标
主要结局
postoperative rescue pethidine consumption
时间窗: 48 hours after operation
in milligram
次要结局
- Postoperative visual analog pain score (VAS score)(48 hours postoperatively)
- Intraoperative fentanyl consumption(1 minute after surgery.)
- Occurrence of postoperative vomiting(2 hours after operation)
- time to first rescue analgesic request(1 minute after requiring analgesics)
- Occurrence of postoperative pruritis(2 hours after operation)
- Occurrence of postoperative nausea(2 hours after operation)
研究者
Yasser S Mostafa, MD
Lecturer of anesthesia
Fayoum University Hospital