A Randomized Comparative study on Ultrasound guided Parasacral Ischial plane block versus Lateral approach of Proximal Sciatic Nerve block in patients undergoing below knee surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare Sensory and motor block characteristic (onset & duration) in both the groups.
研究概览
简要总结
After getting approval from College research committee (CRC) and Institutional Ethical Committee (IEC), Patients fulfilling inclusion criteria will be included in our study.
This prospective randomized study will be carried out in the Department of Anaesthesiology at Teerthanker Mahaveer Medical College and Research Centre.
Pre- anesthetic evaluation will be done prior to surgery.
Written informed consent for the procedure and anaesthesia will be taken from all the patients and participation-information sheet will be filled out.
Each patient will be explained the entire procedure, use of Visual Analogue Scale (VAS) and possible complications.(bleeding, hematoma, bradycardia, tachycardia, hypertension, hypotension, peripheral nerve injury or systemic toxicity to local anaesthetic drug.).
Two groups will be created
Group P (n=40)- PIP (20ml 0.5% ropivacaine)[2]+ Adductor canal block (10ml 0.5% ropivacaine)[3]
Group S (n=40)- Lateral approach for proximal sciatic nerve block(20ml 0.5% ropivacaine) +Adductor canal block.(10ml 0.5% ropivacaine each
Duration of motor block will be bromage – 1.
(0 min,15min,30min,45min,60min, 2hrs 4hrs, 8hrs,12 hrs,
16hrs,18hrs,
and 24hrs.)
Duration of sensory block will be regain of pin prick.
(0 min, 15min, 30min, 45min, 60min, 2hrs 4hrs, 8hrs,12 hrs,
16hrs,18hrs, and 24hrs.)
Post Op the patient will be shifted to PACU and1 gm PCM 8 hrly i/v
will be given as per standard institute protocol. Post OP vitals will be
monitored at 0 min, 15min,30min,45min,60min, 2hrs 4hrs, 8hrs,12 hrs,
16hrs,18hrs, and 24hrs
Pain will be evaluated using visual analogue scale (VAS) that
characterizes and measure pain between 0-10. (0
min,15min,30min,45min,60min, 2hrs 4hrs, 8hrs,12 hrs, 16hrs,18hrs,
and 24hrs.).
Number of patients requiring rescue analgesia will be noted.
Time of first rescue analgesia(I/V tramadol 1.5mg/kg) VAS >4 .
Total rescue analgesic consumption in milligrams over 24 hrs.
The patients will be observed for first 24 hours for bleeding,
hematoma,bradycardia,tachycardia,hypertension,hypotension
, peripheral nerve injury or systemic toxicity to local anaesthetic drug
Data will be analyzed using the appropriate statistical method
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age group 18-70 years Under American Society of Anaesthesiologists physivcal status II to IV, scheduled for lower limb surgeries, Informed and Written consent.
排除标准
- •Infection at site of injection, Allergy to Local Anaesthetics, Duration of the surgery morethan 3 hours.
结局指标
主要结局
To compare Sensory and motor block characteristic (onset & duration) in both the groups.
时间窗: Duration of motor block will be bromage – 1.(0 min,15min,30min,45min,60min, 2hrs 4hrs, 8hrs,12 hrs, 16hrs,18hrs, and 24hrs.) | Duration of sensory block will be regain of pin prick.(0 min, 15min, 30min, 45min, 60min, 2hrs 4hrs, 8hrs,12 hrs, 16hrs,18hrs, and 24hrs.)
次要结局
- To compare VAS score, time for first rescue analgesia, block performance time, total analgesic consumption in 24hrs,haemodynamic parameters, number of patients requiring rescue analgesia, complications in both the groups.(To compare VAS score in both the groups.)
研究者
Dr Prashant Kumar
TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER