Comparison of Epidural Infusion of 0.1% Ropivacaine and 0.2% Ropivacaine for Postoperative Analgesia using Elastomeric Pump in Abdominal Hysterectomies - A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the VAS score at rest, movement and while coughing between the patients getting 0.1% and 0.2% ropivacaine as epidural infusion for pain relief
研究概览
简要总结
Informed written consent will be taken from all the patients.
Patients will be randomly divided into 2 groups, Group R1 (0.1% Ropivacaine) and Group R2 (0.2% Ropivacaine) utilising a computer generated table of random numbers before starting the procedure.
On the day of surgery patients shifted onto the operating table and monitors attached.
In both the groups, General anaesthesia and epidural anaesthesia will be performed by an anaesthesiologist.
Epidural catheterisation is done using 16G,18G or 20G Tuohy’s needle at L2-L2 or L3-L4 space.Position of the catheter is confirmed.
Post surgery patient is sent to Obstetric ICU for pain management and continuous epidural infusion using elastomeric pump at the rate of 5ml/hr is given.
Fentanyl 2mcg/ml is added to the local anaesthetic of all the patients.
Group allocation will be concealed by using coded sealed opaque envelopes which will be opened only by the attending doctor at Obstetric ICU.
If patient complains of pain of VAS more than 3 and less than 5,rescue analgesia of Injection.Paracetamol 1gram iv will be given.
If patient complains of pain of VAS more than 6 Injection.Tramadol 100/50 milligram iv will be given.
Pulse oximeter, non invasive blood pressure and electrocardiogram will be continuously monitored throughout epidural infusion.
Also VAS score at rest ,movement and while coughing will be assessed every 4-5 hourly.Other adverse effects such as motor blockade and hypotension will be assessed.
Epidural infusion will be continuously given during postoperative day 1 and 2 for 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Elective surgeries with ASA Grading 1,2 and 3 2.Patients undergoing abdominal hysterectomy 3.Weight from 50kg to 80kg 4.Height from 145cm to 165cm.
排除标准
- •1.Patient refusal 2.Allergic to Ropivacaine and Fentanyl 3.Local infection at the site of epidural injection 4.Coagulopathy 5.Hypovolemia 6.Patient on anticoagulant therapy 7.Uncooperative patients.
结局指标
主要结局
To compare the VAS score at rest, movement and while coughing between the patients getting 0.1% and 0.2% ropivacaine as epidural infusion for pain relief
时间窗: The time duration taken by the patient to complain of pain with VAS more than 3
次要结局
- To compare the need for rescue analgesia(The time duration taken by the patient to complain pain with VAS more than 5 even after giving rescue analgesia)
- To compare the motor blockade(The time duration taken by the patient to complain of lower limb numbness)
- To compare haemodynamic changes(The time duration taken for mean arterial pressure to fall less than 60)
研究者
Priyadharshini S
SRM Medical College Hospital and Research Institute