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临床试验/NCT06970704
NCT06970704已完成不适用

Erector Spinae Plane Block Combined With General Anesthesia Versus General Anesthesia Alone in Spine Surgeries for Postoperative Pain, A Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Postoperative pain severity

研究概览

简要总结

This prospective single-blind randomized controlled study on 50 patients between 18 and 65 years, both sexes, with ASA I-II and undergoing elective lumbar spine surgical procedures. They were equally divided into two groups: Group Erector Spinae Plane Block (ESPB) (Study): (number = 25) received Erector Spinae Plane Block (20 ml bupivacaine 0.25%) combined with general anesthesia. Group General Anesthesia (GA) (Control): (number = 25) received conventional general anesthesia.

详细描述

In both groups, on arrival to the operation room, a multi-channel monitor will be attached to the patient to display continuous electrocardiogram (ECG) monitoring, heart rate (HR), non-invasive blood pressure, pulse oximeter, temperature probe, capnogram, and anesthetic gas analysis. An intravenous line will be secured, then lactated Ringer's solution will be started at 5 ml/kg/h. Ten minutes before induction of anesthesia, all patients will be premedicated with intravenous midazolam 0.02 mg/kg. Patients will be preoxygenated with 100% oxygen for 3 minutes. In both groups, induction of anesthesia will be carried out by intravenous administration of fentanyl 1 µg/kg, lidocaine 1.5 mg/kg, and propofol 2 mg/kg. After loss of verbal communication, 0.5 mg/kg atracurium will be administered. Intermittent positive pressure ventilation will be adjusted to maintain an end-tidal carbon dioxide partial pressure between 30 and 35 mmHg. Anesthesia will be maintained with 1-2% isoflurane, 0.1 mg/kg atracurium bolus doses will be administered every 20 minutes, and 0.5 µg/kg fentanyl will be administered every 30 minutes.

In the Erector Spinae Plane block (ESPB) group, after prone positioning and before surgery, Erector Spinae Plane Block will be performed bilaterally using a low-frequency curved ultrasound transducer placed in a longitudinal orientation 3 cm lateral to the spinous process one vertebral level above a predetermined marked surgical incision. An 8-cm 22-gauge block needle will be inserted in a cephalad to caudad direction until the tip lies in the interfascial plane below the erector spinae muscle; the block will be performed by injection of 20 ml of 0.25% bupivacaine. In both groups, fentanyl 1 µg/kg as rescue analgesia will be given based on hemodynamic parameters.

If the mean arterial blood pressure (MAP) has fallen below 65 mmHg, 5 mg of ephedrine will be administered, and an intravenous bolus of 0.5 mg of atropine will be administered in case of bradycardia if the heart rate ≤50 bpm. The blood pressure will return to the baseline value before surgical field closure. Then at the end of surgery, the isoflurane vaporizer will be turned off, and the muscle relaxant will be reversed with neostigmine 0.04 mg/kg and atropine 0.02 mg/kg. The endotracheal tube will be removed after the patient regains consciousness and full muscle power, breathes spontaneously, and responds to verbal commands. Isoflurane consumption was measured at the end of surgery.

Postoperative pain management:

A standardized analgesic regimen will be prescribed in the postoperative period. All patients will receive 1 gm of paracetamol every 6 h. If the numeric rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered by an investigator blinded to group assignment.

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
否

入选标准

  • •Patients aged from 18 and 65 years, both sexes
  • •The American Society of Anesthesiology (ASA) physical status I-II
  • •Scheduled for elective lumbar spine surgical procedures

排除标准

  • •Coagulation disorders
  • •BMI > 30 or < 18 kg/m2
  • •Patients with surgical site infection
  • •Known sensitivity or contraindication to local anesthetics
  • •History of psychological disorders
  • •Patients with unstable spine integrity like fractures or scoliosis
  • •Hypertensive, cardiac, and diabetic patients,
  • •Known alcohol or substance abuse within the last 6 months and Daily opioid intake

研究组 & 干预措施

Group Erector Spinae Plane Block (ESPB) (Study)

Active Comparator

Patients in this group will receive Erector Spinae Plane Block (20 ml bupivacaine 0.25%) combined with general anesthesia

干预措施: Erector Spinae Plane Block using 0.25 % bupivacaine (Other)

Group General Anesthesia (GA) (Control)

Active Comparator

Patients in this group will receive conventional general anesthesia

干预措施: Erector Spinae Plane Block using 0.25 % bupivacaine (Other)

结局指标

主要结局

Postoperative pain severity

时间窗: Postoperatively Day 1

Using Pain Numeric Rating Scale Scores

Time to the first postoperative rescue analgesic

时间窗: Postoperatively Day 1

Time to first use of morphine

Fentanyl consumption.

时间窗: During Intraoperative period

Intraoperative fentanyl consumption

Isoflurane consumption.

时间窗: During Intraoperative period

Intraoperative fentanyl and isoflurane consumption.

次要结局

  • Postoperative nausea and vomiting(Postoperatively Day 1)
  • Changes in mean arterial pressure(Immediately before the operation till Postoperatively Day 1)
  • Changes in heart rate(Immediately before the operation till Postoperatively Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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