Comparative study of analgesic effectiveness in Retrolaminar block with intravenous patient controlled analgesia (PCA) in adult patients undergoing percutaneous nephrolithotomy surgery : A randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To measure perioperative fentanyl consumption in 24 hours
研究概览
简要总结
Comparative study of analgesic effectiveness in Retrolaminar block with intravenous patient controlled analgesia (PCA) in adult patient undergoing percutaneous nephrolithotomy surgery: A randomized controlled trial
INTRODUCTION
- Percutaneous nephrolithotomy is a surgical procedure commonly used to treat large kidney stones. It is usually accompanied by severe pain and discomfort postoperatively.
- Regional blocks have been used to control post operative pain are QLB, subcostal block, paravertebral block and erector spinae block.
- Ultrasounded guided retrolaminar block is recently introduced as a regional analgesia technique for surgeries in thoracolumbar region.
AIM :To evaluate the analgesic effect of US guided RLB in terms of reducing the perioperative (24 hours) opioid consumption in patients with PCNL surgery.
OBJECTIVE
Primary objective: To measure perioperative total fentanyl consumption in 24 hours.
Secondary objective: Time of first rescue analgesia
: NRS score postoperative period 30 min,2 hour,4 hour,8 hour,12 hour,24 hour
METHODOLGY
STUDY DESIGN: double blinded, randomised controlled trial
STUDY POPULATION : All patient undergoing PCNL procedure in AIIMS patna
SAMPLING TECHNIQUE: Patient will be divided by computer generated randomization number into group I and II
Group I: will receive general anesthesia only
Group II: will receive general anesthesia and retrolaminar block.
After taking written consent from the study participants and will explain about the procedure technique and education about numerical rating score (NRS) and PCA pump to patient.
The patient will be nil per oral for 8 hours prior to procedure. standard monitoring pulse oximetry, non invasive blood pressure and ECG will be attached after entering the operation theatre and baseline value will be noted. All patient in both group will receive general anesthesia. Patient will induced with fentanyl 2 mcg/kg, propofol 2 mg/kg and atracurium 0.5mg/kg.
After induction patient will be intubated with endotracheal tube. Anesthesia will be maintained with isoflurane, oxygen and air to maintain minimum alveolar concentration(MAC).
After placing the patient to prone position all patients of group II will receive US guided RLB at T9 level. For this we will place a linear US probe longitudinally in midline to identified spinous process of T9 level vertebra.
Following this the US probe will be slide slightly laterally toward the operating side to identified following structure the lamina ( horse head sign of hyperechoic structure).erector spinae muscle and the hyperechoic dura between two lamina.
The needle will be inserted in plane to the probe in cranial or caudal direction towards the targeted lamina (1 to 1.5 cm lateral to the target spinous process) and needle tip will be contacted with lamina.
After negative aspiration for blood and air 0.25% bupivacaine of total volume 20 ml will be injected. patient of group I will not receive any intervention.At the end of surgery total intraoperative fentanyl consumption will be noted in both group.
Postoperative all patients will receive paracetamol 1 gm iv every 6 hourly. All patient enrolled in study will be provided with PCA fentanyl pump with 0.5mcg/kg fentanyl at each loading but not infusion.
Lockout interval 15 min. The patient will be instructed to use the pump when NRS will be 4 or above. The fentanyl consumption will be recorded during intra and post operative 24 hours by a researcher who is not a member of the surgical team (30 min,2 hours,4 hours,8 hoyrs,12 hours,24 hours).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 18 to 70 (Either sex) ASA I/II BMI <30kg/m2.
排除标准
- •History of focal neurological deficit psychiatric disorder coagulation disorder liver pathology use of any opioid in last 6 month.
结局指标
主要结局
To measure perioperative fentanyl consumption in 24 hours
时间窗: To measure perioperative fentanyl consumption in 24 hours
次要结局
- Time of first rescue analgesia(NRS score at post operative period)
