Comparison of lignocaine pretreatment with torniquet and lignocaine admixture with propofol in alleviating pain on propofol injection - A randomised clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- To compare the incidence of pain during propofol injection between pretreatment with lignocaine with tourniquet and lignocaine admixture in alleviating pain on propofol injection using VRS score.
研究概览
简要总结
Patients satisfying eligibility criteria will be enrolled in the study after obtaining written informed consent. Standard pre-operative assessment will be done and will include history of allergies to egg or soya bean. Premedication will be decided by the anaesthesia team managing the patient.
All patients will be explained about the grading of pain using the VRS score.
In the operation theatre, all standard anesthetic monitors will be connected (electrocardiogram, non-invasive blood pressure, pulse -oximetry).
An 18 G intravenous cannula will be secured in the largest dorsal vein of the non-dominant hand and. Intravenous infusion fluid will be connected.
Fentanyl 2mics/kg IV will be given to all patients.
All study drugs will be maintained at room temperature and used within 30 min after preparation. For group A 1ml NS for pretreatment , 10ml Propofol and 1 ml lignocaine 2% will be prepared and used . for group B 1 ml lignocaine 2% for pretreatment , 10 ml propofol and 1 ml NS .
In group A, 2 ml of normal saline will be given through the injection port, while a torniquet is placed 2 cm above wrist to create stasis and the IV fluid flow is stopped. The stasis is released after 1 minute Lignocaine admixture by adding 1 ml of 2% lignocaine to 100mg propofol, as per standard procedure is given. In group B, 2 ml of 1% Lignocaine will be given through the injection port, while a torniquet is placed 2 cm above wrist to create stasis and the IV fluid flow is stopped. The stasis is released after 1 minute. Propofol 100mg will be mixed with 1 ml of normal saline and will be used for induction of anaesthesia.
0.5mg/kg of Propofol will be given over 5 seconds through flowing IV line.
Spontaneous complaints of pain will be noted. If there are none, after 15 seconds following the injection, patients will be questioned about the incidence of pain. Patients will be asked to rate the severity of pain using the Verbal Rating Score for pain. scale. This will be done by another anaesthesiologist who is unaware of the group assignment of the patient.
After the last recording, further induction will be as decided by attending anaesthesiologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-60 years ASA class I, II Patients undergoing elective surgery under general anaesthesia in whom induction with propofol is planned.
排除标准
- •patients with known allergies to Propofol or any of its components patients planned for rapid sequence induction, pregnant patients.
- •patients with difficult venous access or thin caliber veins.
- •Patients on any analgesic medications pre operatively.
结局指标
主要结局
To compare the incidence of pain during propofol injection between pretreatment with lignocaine with tourniquet and lignocaine admixture in alleviating pain on propofol injection using VRS score.
时间窗: after 15s of propofol injection or as soon as patient complains of pain
次要结局
- To compare the Severity of pain on propofol injection between the groups using VRS(after 15s of propofol injection or as soon as patient complains of pain)
研究者
Dr Fathima Amna P
Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry