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临床试验/NCT03968146
NCT03968146已完成2 期

Ultrasound Guided Erector Spinae Plane Block in Scoliotic Adolescents Undergoing Posterior Spine Instrumentation . A Randomized Controlled Trial

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

For scoliotic surgeries, Erector Spinae Plane Block (ESPB) can add to the multimodal approach for perioperative pain management with decreasing the opioids requirement, improving recovery and decreasing ICU stay.

详细描述

All patients will be assessed clinically and investigated for Pulmonary function test and Echocardiography. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) and liver function tests.

an online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the two study groups. Random allocation numbers will be concealed in opaque closed envelops.participants and those assessing/analyzing the outcome(s) will be blind to group assignment.

Eutectic Mixture of Local Anesthetics (EMLA) cream will be applied to the site of venous puncture. After insertion of venous access, all children will receive midazolam at a dose of 0.1 mg/Kg. Intraoperative monitoring will include continuous electrocardiogram (ECG), pulse oximetry, invasive arterial blood pressure, end-tidal carbon dioxide (CO2), inhaled gas analyzer and temperature monitoring.

General anesthesia will be induced in both groups (Erector Spinae group and control group) using propofol 2.5 mg/kg over 20-30 seconds, atracurium 0.5 mg/kg to facilitate endotracheal intubation and fentanyl 1 µg/kg. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium infused as 0.5 mg/kg/hr. All patients will receive IV ranitidine 2 mg/kg, ondansetron 0.1 mg/kg, cefotaxime 50 mg/kg and acetaminophen 15 mg/kg. An arterial catheter and a urinary catheter will be placed. Then patients will be turned to the prone position.

In group E: will receive Erector Spinae Plane Block (ESPB) In group C: control group will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision. After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • American society of Anesthesia classification (ASA) I-II
  • Patients undergoing dorsal spine instrumentation for scoliosis.

排除标准

  • Refusal of block.
  • Bleeding tendency with prothrombin concentration PC less than 75 % or platelet count less than 150,000/µL.
  • Skin lesion, wounds or infection at the puncture site.
  • Known allergy to local anaesthetic drugs.

研究组 & 干预措施

Group E

Active Comparator

patients will receive Erector Spinae plane block in addition to intravenous fentanyl

干预措施: Erector Spinae Plane Block (Procedure)

Group E

Active Comparator

patients will receive Erector Spinae plane block in addition to intravenous fentanyl

干预措施: Fentanyl (Drug)

Group E

Active Comparator

patients will receive Erector Spinae plane block in addition to intravenous fentanyl

干预措施: rescue Morphine (Drug)

Group E

Active Comparator

patients will receive Erector Spinae plane block in addition to intravenous fentanyl

干预措施: pethidine (Drug)

Group E

Active Comparator

patients will receive Erector Spinae plane block in addition to intravenous fentanyl

干预措施: Ketorolac (Drug)

Group E

Active Comparator

patients will receive Erector Spinae plane block in addition to intravenous fentanyl

干预措施: Acetaminophen (Drug)

Group C

Other

Control group will receive only intravenous fentanyl.

干预措施: Fentanyl (Drug)

Group C

Other

Control group will receive only intravenous fentanyl.

干预措施: additional Fentanyl (Drug)

Group C

Other

Control group will receive only intravenous fentanyl.

干预措施: Morphine (Drug)

Group C

Other

Control group will receive only intravenous fentanyl.

干预措施: rescue Morphine (Drug)

Group C

Other

Control group will receive only intravenous fentanyl.

干预措施: pethidine (Drug)

Group C

Other

Control group will receive only intravenous fentanyl.

干预措施: Ketorolac (Drug)

Group C

Other

Control group will receive only intravenous fentanyl.

干预措施: Acetaminophen (Drug)

结局指标

主要结局

Total morphine consumption

时间窗: the first 24 hours post-operative period.

Total postoperative rescue morphine consumption in mg/kg for each group in the first 24 hours post-operative period.

次要结局

  • Total fentanyl consumption(intraoperative period)
  • Visual Analogue Scale(the first 24 hours post-operative period.)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

maged gamal

anethesia demonstrator

Kasr El Aini Hospital

研究点 (1)

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