Efficacy of Bolus versus fractionated injection of hyperbaric bupivacaine in spinal anaesthesia among patients undergoing femur fracture surgery: A randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TO COMPARE HEAMODYNAMIC PARAMETERS (HEART RATE AND MEAN ARTERIAL BLOOD PRESSURE) BETWEEN THE TWO STUDY GROUPS.
研究概览
简要总结
Spinal anaesthesia (SA) is routinely used to provide anaesthesia for femur fracture surgeries. Here the entire dose of the local anesthetic is administered all at once as a bolus injection . It has quick onset making it suitable for procedures requiring fast and complete anaesthesia. Bolus injection is straightforward to administer and requires minimal manipulation of syringe.
In recent literature, studies have been conducted especially in Caesarean section patients in which local anaesthetic is injected in fractionated manner for Spinal anaesthesia. In this method two thirds of the total calculated dose of local anaesthetic is initially injected ; and one- third dose after a time-gap of 90 seconds (1). These studies have observed dense spinal blockade with lower maximum sensory level in these patients.
In Spinal anaesthesia there is sensory motor as well as sympathetic blockade. Level of sympathetic blockade is higher than sensory blockade(2). If there is higher sympathetic blockade it leads to severe hypotension. In older population which routinely come for femur fracture surgeries, this hypotension is deleterious considering associated co morbidities.
We will be conducting a prospective study to compare Efficacy of Bolus versus fractionated injection of hyperbaric bupivacaine in spinal anaesthesia among patients undergoing femur fracture surgeries.
Primary outcome of our study will be comparison of hemodynamic parameters. Secondary outcome will be comparison of spinal block characteristics. We hypothesize that giving local anaesthetic in fractionated manner is better method
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Elective Femur fracture surgeries under Spinal Anaesthesia.
- •Patients between age 60-80 years
- •ASA grade I, II and III.
排除标准
- •Subjects with suspected inability to comply with the study procedure.
- •Known allergy to drug study.
- •History of liver Renal and Cardiac disease.
结局指标
主要结局
TO COMPARE HEAMODYNAMIC PARAMETERS (HEART RATE AND MEAN ARTERIAL BLOOD PRESSURE) BETWEEN THE TWO STUDY GROUPS.
时间窗: Intra Op Monitoring of Heart Rate Blood pressure and Mean arterial Pressure every 3 minutes for first 20 minutes. Thereafter every 10 minutes till regression of sensory block to L1 level
次要结局
- Intra Op Monitoring of motor & sensory characteristics(Level of sensory block was checked every 3 minutes till peak sensory level that is two consecutive reading at the same dermatomal level will be achived. Thereafter sensory block will be tested every 20 min till the block regression to L1 level.Motor blockade will be checked every 3 minutes for first 20 minutesfrom start of surgery & every 10 minutes thereafter.)
研究者
Ritesh Bhola
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD