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临床试验/NCT05356715
NCT05356715已完成不适用

Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Post-operative Recovery in Cardiac Surgery With Median Sternotomy. Randomized Controlled Trial

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2022年1月1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
发起方
入组人数
239
试验地点
2
主要终点
Time to extubation after cardiac surgery

研究概览

简要总结

This study aim is to measure the time of extubation in patients receiving ultrasound guided bilateral Erector Spinae Plane (ESP) block after cardiac surgery .

详细描述

On arrival to the operating room, an I.V 20 G cannula will be inserted. . and 500 ml of ringer acetate solution will be infused within 30 minutes. .A five-lead electrocardiogram, a pulse oximeter and an noninvasive blood pressure monitor will be applied. Basal readings ( HR,blood pressur) will be recorded . Then arterial cannula will be inserted in the radial artery of the non dominant hand. Sedation with Midazolam 0.02 mg/kg will be administered at the pre- anethesia room. . Induction will be done using titrated doses of propofol (1-2 mg /kg). ,atracurium 0.5 mg /kg and 200 mcg of fentanyl

  • patients will be randomly assigned into two groups :
  • Group A (n=110): will receive Ultrasound guided bilateral ESBP.
  • Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr. Patients in group A will be positioned in the lateral position , ESPB will be done under complete aseptic conditions , using , linear ultrasound probe(Philips HD11XE Ultrasound System) , to locate the ESP at the level of the fifth dorsal vertebrae , 22 G spinal needle will be used to inject 20 ml of 0.25% of bupivacaine in the ESP bilaterally, block will done by an expert anesthesiologist , who will not be included in the data collection.

Patients in group B will be on fentanyl infusion 2 mcg /kg/hr. Blood pressure and heart rate will be recorded every 15 min until we go on CPB. An incremental dose of fentanyl bolus 50 mcg will be given when there is increase in the heart rate or the blood pressure by 20% from the baseline. If more than tow boluses needed, then the block will be considered as failed block .Then patients will go on CPB after heparinization and cannulation of the aorta and the venous system ( single venous or double venous ), after valve replacement or CABG done , weaning from the CPB , and inotropic support will start if needed . Then patient will be transferred to ICU mechanically ventilated on assisted control mode, FiO2 :0.6 , TV: 6ml /kg , RR: 12-16/min , PEEP:5. After fulfilling the criteria for extubation ( such as P/F ratio more than 200 , spontaneous tidal volume greater than 5 mL/kg, vital capacity greater than 15 mL/kg, maximum inspiratory pressure (MIP) greater than 25 cm H2O,, fully conscious patient , stable hemodynamics and accepted valves for the arterial blood gases and chest tube drains, patient will be extubated.

All patients will be observed in the postoperative period at 4, 6, 8, 12,24 hours interval and all hemodynamics will be recorded including heart rate ,blood pressure ,the need for incremental doses of narcotics, pain assessment using the Numerical rating scales (NRS), (use numbers to rate pain), and time of extubation ( the time from the arrival to the ICU until successful extubation).

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patient aged from 18 to 70 years old
  • •Adult congenital heart disease.
  • •patients undergoing valve replacement due to valvular heart disease
  • •Coronary artery bypass grafting( CABG) without great saphenous vein (GSV) harvesting.

排除标准

  • •Emergency surgeries.
  • •Allergy to opioids and local anesthetic
  • •Patients on high inotropic support ( 100 ng/ kg/ min adrenaline or noradrenaline)
  • •Patients with preoperative known chest disease ( pulmonary function tests showing moderate to severe restrictive or obstructive pulmonary disease
  • •Long cardiopulmonary bypass (CPB) time ( more than 2 hours )
  • •Difficult intubation (needs more than 3 attempts bu trained anesthesiologist for a successful endotracheal intubation.)
  • •Skin lesions or infection at site of proposed needle insertion.
  • •Bleeding disorders (INR >1.4 ),( platelet count <100,000/mm3 )

研究组 & 干预措施

Group A

Experimental

● Group A (n=110): will receive Ultrasound guided bilateral ESBP.

干预措施: Ultrasound guided bilateral ESBP (Procedure)

Group B

Active Comparator

● Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr

干预措施: Ultrasound guided bilateral ESBP (Procedure)

结局指标

主要结局

Time to extubation after cardiac surgery

时间窗: 24 hours

Time to extubation after cardiac surgery (from the arrival to ICU till successful extubation)

次要结局

  • Perioperative fentanyl consumption.(24 hours)
  • pain scoring using the Numerical rating scales (NRS)(24 hours)

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

Khaled Abdelfattah Abdallah Sarhan

principal investigator

Kasr El Aini Hospital

研究点 (2)

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