A prospective observational study to assess post operative analgesia following addition of dexmeditomidine or dexamethasone to ropivacaine in erector spinae plane block in children undergoing thoracic surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To study and compare the duration of post operative analgesia following addition of dexamethasone ( 0.15 mg/kg) or dexmedetomidine ( 1mcg/kg) to ropivacaine versus plain ropivacaine in ESPB following thoracic surgeries ( open /VATS)
研究概览
简要总结
Thoracic surgeries like decortications can be done by either open approach or as video assisted thoracoscopic surgeries (VATS). Thoracotomy surgeries which involve stripping of pleura can give rise to significant pain. Adequate analgesia while recovering from thoracic surgeries is essential for providing patient comfort and preventing complications such as pneumonia and respiratory failure.
The erector spinae plane block (ESPB), first described by anaesthesiologist Mauricio Forero in 2016 is a multi-dermatomal sensory block that provides regional anaesthesia to the ipsilateral chest wall. The site of action is the dorsal and ventral rami of the thoracic nerves, typically extending from the level of T3 to T10. It has been tried for analgesia in thoracic, surgical and chest trauma patients, providing excellent pain relief while reducing narcotic requirements. The ESPB does not pose risk of direct neurological injury and can be placed when the patient is anaesthetized.
In this study patients undergoing thoracic surgeries who receive general endotracheal anaesthesia and erector spinae plane block (ESPB) will be observed. Patient is taken inside the operation theatre , all the monitors are attached and general endotracheal anaesthesia is given using injection propofol 3mg/kg or inhalational sevoflurane. Non depolarising muscle relaxant is given . All patients receive injection fentanyl 2mcg/kg.
Patient is given lateral decubitus position and ESPB is given between T5/T6 transverse process and erector spinae muscle using either plain ropivacaine ( group R- 0.4ml/kg of 0.5% ropivacaine or ropivacaine with adjuvants ( group RD 0.15mg/kg or group RDM 1mcg/kg dexmeditomidine ).
Intra operatively the patient is monitored and if there is increase in pain stimuli in the form of increase in heart rate or systolic blood pressure by 20% then rescue analgesic injection fentanyl 0.5 mcg/kg is given and noted
.After extubation the patient is observed in recovery room for 3 hours and if post operative pain score (VAS score or FLACC) is >3 injection fentanyl 0.5mcg/kg is given and noted. After 3 hours the patient is shifted to ward and if the pain still perssits injection paracetamol 15mg/kg is given and any other complications if present are noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •All the children between the age group of 6 months to 18 years who have received general endotracheal anaesthesia plus Erector spinae plane block for open thoracic surgeries or VATS using plain ropivacaine or ropivacaine with adjuvants.
排除标准
- •1.Patients who are in altered sensorium 2.Patients who are already sedated or on ventilatory support since visual analog score (VAS) or FLACC score cannot be checked in them.
结局指标
主要结局
To study and compare the duration of post operative analgesia following addition of dexamethasone ( 0.15 mg/kg) or dexmedetomidine ( 1mcg/kg) to ropivacaine versus plain ropivacaine in ESPB following thoracic surgeries ( open /VATS)
时间窗: The post operative pain score would be assessed 3 hours 12 hours, 24 hours and 36 hours after the procedure
次要结局
- To compare and assess the following in the group R (plain ropivacaine 0.4ml/kg of 0.5% ropivacaine), group RD (0.4ml/kg of 0.5% ropivacaine + 0.15 mg/kg dexamethasone) and group RDM (0.4ml/kg 0f 0.5% ropivacaine + 1 µg/kg dexmedetomidine)(1. The requirement of intra operative analgesic)
研究者
Tarannum Shaikh
LOKMANYA TILAK MUNCIPAL MEDICAL COLLEGE AND HOSPITAL
