A Randomized Comparative study for evaluation of diaphragmatic function after USG guided Intermediate cervical plexus bock 10ml of 0.3 percent versus 10ml of 0.5 percent ropivacaine in cases of upper limb surgeries under USG guided Supraclavicular brachial plexus block at SMS medical college, Jaipur
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- from the baseline.
研究概览
简要总结
After obtaining Institutional Ethics Committee approval and written informed consent, 100 patients fulfilling inclusion criteria and exclusion criteria will be included.
In the operation theatre, patient will be identified and received, written and informed consent, PAC, and fasting status will be checked. Routine non-invasive monitors will be attached and vital parameters like pre-operative pulse rate, non-invasive blood pressure, and oxygen saturation will be noted. Peripheral venous access will be established in upper limb with 18G IV cannula and intravenous Ringer Lactate solution will be started.
Patient randomization will be performed using computer generated method.
GROUP A (n= 50): patients will receive 10ml 0.5% ropivacaine in intermediate cervical plexus block with 1ml Iohexol (after test done) dye under the guidance of USG.
GROUP B (n= 50): patients will receive 10ml 0.3% ropivacaine in intermediate cervical plexus block with 1ml Ioxehol dye (after test done) under the guidance of USG.
Spread of dye will be assessed immediately using image intensifier.
Assessment of the diaphragmatic excursion and thickness by ultrasonography will be done at 0, 40 minutes after ICPB.
Both the groups will receive 10ml 0.5% ropivacaine under ultrasound guided Supraclavicular brachial plexus block on the same side.
Assessment of the diaphragmatic excursion and thickness by ultrasonography will be done at 40 minutes after SCBP block.
After achieving adequate sensory block, surgery will be started.
Intraoperative parameters such as Heart Rate, SBP, DBP, MAP and SpO2 will be monitored according to proforma.
At the end of surgery, patients will be shifted to recovery room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing upper limb surgery.
- •Adult patients aged 18-65 years of both sexes.
- •Patients belonging to American Society of Anaesthesiologists (ASA) physical status I, II and III.
- •Patients giving consent for participation.
排除标准
- •Patient should not be part of any other study.
- •History of allergy to local anaesthetics and Iohexol dye.
- •Patients on anticoagulant therapy and/or history of coagulation disorders.
- •Local infection at the proposed site of intermediate cervical plexus block or supraclavicular brachial plexus block.
- •Patients with respiratory illness/compromise.
- •Patients with existing sensorineural deficit in the upper limb to be operated.
- •Patients not able to report assessment of block.
结局指标
主要结局
from the baseline.
时间窗: Mean change in diaphragmatic excursion and thickness from the baseline at 40 minutes after ICPB.
Mean change in diaphragmatic excursion and thickness
时间窗: Mean change in diaphragmatic excursion and thickness from the baseline at 40 minutes after ICPB.
次要结局
- 1) Change in diaphragmatic(excursion after SCBP block)
研究者
Dr Vandana Mangal
Sawai Man Singh medical college, Jaipur