Efficacy of ultrasound Guided Erector Spinae Plane Block in Percutaneous Nephrolithotomy (PCNL)Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post operative Pain by VAS Scores
研究概览
简要总结
A sealed envelope randomization willbe employed to allocate patients intotwo groups either to receive ESP block with local anaesthetic drug bupivacaine and patient receiving ESP blockwith normal saline.
Patient will be premedicated withintravenous inj. glycopyrrolate (5mcg/kg), inj. Midazolam (0.05mg/kg), inj.Fentanyl (2mcg/kg). Induction will be achieved by inj. Propofol (2mg/kg) and intubation will befacilitated with inj. vecuronium (0.08mg/kg). Anaesthesia will be maintainedwith 50% of nitrous oxide in oxygen and isoflurane along with inj.vecuronium(0.02mg/kg) maintenance dose as required. All hemodynamics parameter will be recordedat every 15 min interval until patient will be shifted from the operating room.
Erectorspinae plane block will be performed after completion ofpcnl surgery under ultrasound guidance using a linear transducer.
Group E (n=30): group E will receive Erector Spinae Plane Block with Local Anaesthetic (LA) mixture 10 ml of 0.5% Bupivacaine, 5 ml of Lignocaine2%, 1 ml (50mcg) of fentanyl, 4 ml of NS to make a mixture of 20 ml, which will be injected on the side of surgery.
Group C (n=30): group C willreceive Erector Spinae Plane Block with 20 ml of normal saline injected on the side of surgery.
InGroup E patients, Erector Spinae Plane (ESP) block will be performed in prone position after ensuring skin asepsis, we place high frequency [5-13 MHz] linear ultrasound transducer in sterile sheath 3 cm lateral to the T9 spinous processto visualize the back muscles:trapezius above, rhomboid major in the middle, and erector spinae muscle on the bottom. A 23G 10-cm Touhy needle will be inserted using an in plane superior to inferior approach until the needle touched the TransverseProcess crossing all three muscles. Avolume of 20 ml of LA mixture will be injected.
In GroupC patients, same procedure as above will beperformed, but in place of drug we will inject a volume of 20 ml of normal saline on the surgery side.
After completion of ESP blockprocedure, all the anaesthetic agentwill be stopped and after the onset of spontaneous respiration, residualneuromuscular blockade will be reversed with Inj. Neostigmine (5mcg/kg) andInj. Glycopyrrolate (10 mcg/kg) and extubation will be done. before shifting the pts to postoperative ward we will give injectionparacetamol 15mg/kg body wt as analgesic to all pts.
PTs will be assessed for pain by VASscores (ranging from 0 indicating no pain to 10 indicate extreme pain) will berecorded 30 min and 2,4,6,12,and 24 hr. postoperatively.
When VASScore is more then 4 we will give intravenous tramadol 100 mg (maximum up to400 mg) as postoperative rescue analgesic. . The amount of rescue analgesia require in both groups during first 24h after operation , pts satisfactionscore using Likert Verbal Rating Scaleand complications if any occur will be recorded.
The hemodynamic parameters like Heart rate, Systolic Blood pressure,Diastolic blood pressure , Mean arterial pressure, Saturation(spo2), Etco2will be taken after the block and patients will be monitered upto 24 hrs after the block. Adverse events such as Bradycardia (HR <50 bpm or 20% decrease from the baseline value), Hypotension (fall in blood pressure by 20% from the baseline or an absolute MAP <60 mmHg) , Nausea, Vomiting, Dryness of mouth or any other events during or within the procedure will be noted. Bradycardia will be treated with increment doses of injection Atropine 0.3mg and Hypotension will be managed with a bolus of IV crystalloids or with increments of injection Mephentermine 6 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA I and II
- •Patients between the age of 35-65 years
- •Patients with body mass index between 18-30 kg/m2 [BMI 18-30 kg/m2]
- •Pt. posted for elective PCNL surgery.
- •Duration of surgery between 90-120 minutes.
排除标准
- •Patients refusal.
- •Neuro Psychiatric Disorder or on Chronic use of Psychoactive medications.
- •Hepatic impairment.
- •History of Epilepsy.
- •Pregnant and lactating females.
- •History of alcohol and drug abuse.
- •Coagulation abnormality.
- •9 Allergy to any study drug.
结局指标
主要结局
Post operative Pain by VAS Scores
时间窗: 30 min, 2h, 6h,12h and 24h postoperatively
次要结局
- Total Rescue Analgesic Required(in 24 h)
- Satisfaction level(12 h after surgery)
