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临床试验/NCT03491319
NCT03491319已完成不适用

Cephalic Spread of Block With Head Down Tilt in Spinal Anaesthesia - A Randomised Controlled Study

Nitte University0 个研究点目标入组 60 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Maximum height of block

研究概览

简要总结

Subarachnoid block has become an established and reliable method of providing anaesthesia for lower abdominal and lower limb surgeries. Several factors determine the spread of local anaesthetic solutions in CSF. Among them, patient position is an important determining factor. Anesthesiologists give various degrees of head down tilt which they believe is both safe for the patient and will result in adequate level of block. Often these are arbitrarily done by the operator as most of the operation theatre tables are not equipped with any device to measure the accurate degree of tilt. As there is no agreement on the effect of Trendelenberg position on height of subarachnoid block, the current clinical study will be undertaken to estimate the effect of operation theatre table tilt at the time of lumbar puncture on the height of subarachnoid block.

详细描述

Subarachnoid block has become an established and reliable method of providing anaesthesia for lower abdominal and lower limb surgeries. A definitive advantage that subarachnoid block provides is the profound nerve block that can be produced in a large part of the body by the relatively simple injection of a small amount of local anaesthetic. Twenty-five factors have been invoked as determinants of the spread of local anaesthetic solutions in CSF. Among them, patient position is an important determining factor.

Operation theatre table tilts have been used to influence the spread of hyperbaric solution to ultimately influence the final height of the block. Studies have shown that a 10 degree head down tilt can result in cephalad spread of analgesia when compared to the horizontal group. So, in cases where the spinal block level was not high enough to perform a given surgery, the Trendelenburg position has been used to extend the level of the block. Hence, it is assumed that a higher level of block can be achieved with a smaller volume of the local anaesthetic agent, thus reducing the side effects. But others have noted that there was no statistically significant increase in the level of block even with 15 degree head down tilt.

In spite of this, anesthesiologists give various degrees of head down tilt which they believe is both safe for the patient and will result in adequate level of block. Often these are arbitrarily done by the operator as most of the operation theatre tables are not equipped with any device to measure the accurate degree of tilt.

An application called clinometer that utilizes the gyroscope sensor and determines the plane of the gadget in vertical as well as horizontal directions has been described. This application can be used to measure the exact degree of tilt given after sub arachnoid block.

As there is no agreement on the effect of Trendelenberg position on height of subarachnoid block, the current clinical study will be undertaken to estimate the effect of operation theatre table tilt at the time of lumbar puncture on the height of subarachnoid block.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

First anaesthesiologist performed the spinal anaesthesia, gave table tilt using clinometer according to group allocation and assessed spinal blockade till 10 min after intrathecal injection. Thereafter it was done by the second anaesthesiologist who was blinded to the patient grouping

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients belonging to ASA physical status I and II undergoing lower abdominal and lower limb surgeries under spinal anaesthesia

排除标准

  • Patient refusal
  • contraindicated for spinal anaesthesia
  • allergy to local anaesthetic agents used
  • obesity (body mass index >29 kg/m2)
  • Pregnancy

研究组 & 干预措施

Group C Control

Placebo Comparator

spinal anaesthesia was given with table in neutral positon. Same position was maintained after spinal anaesthesia

干预措施: Group C - neutral (Procedure)

Group X

Active Comparator

spinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal

干预措施: Group X - head low tilt (Procedure)

Group Y

Active Comparator

the table was put in 10 degree head low position before proceeding to give spinal anaesthesia. Head low position was maintained for 10 minutes following spinal

干预措施: Group Y - head low tilt (Procedure)

结局指标

主要结局

Maximum height of block

时间窗: from 5 minutes to 150 minutes after intrathecal injection

Two segment regression time

时间窗: from 5 minutes to 150 minutes after intrathecal injection

time from injection of spinal drug to regression of the sensory block by two segments from the maximum

次要结局

  • Hypotension(every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection)
  • Bradycardia(every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection)
  • Tachycardia(every minute for 5 min after intrathecal drug administration, every 5 min till 30 min and thereafter every 10 minutes till 150 minutes after intrathecal injection.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sara Jaison

Junior Resident

Nitte University

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