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临床试验/CTRI/2025/01/079526
CTRI/2025/01/079526尚未招募2 期

A Randomised Controlled study- To Compare The Effect Of High Volume And Low Volume Of Bupivacaine Drug On Intra Cranial Pressure After Giving Caudal Block In Paediatric Population.

Dr Ashneil Kohli1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
2 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 the effect of two different volumes of the same drug given intra operatively after giving caudal block and measuring optic nerve sheath diameter by checking ultrasonographically.

研究概览

简要总结

Caudal block is commonly used technique in all types of surgery below the umbilicus  for postoperative analgesia in paediatric patients because of its safety and efficacy

Unfused sacral hiatus allows for easy and safe access into the epidural space. However, caudal epidural Has its own advantages and disadvantages. The main disadvantages of block include urinary retention , excessive motor blockade especially if higher volume and concentration of local anaesthetic drug  has been used.

Therefore, Different volumes according to surgical procedures has been advocated for caudal epidural analgesia..

The optic nerve sheath diameter (ONSD) is a measure of diameter of the protective sheath surrounding the optic nerve. Studies suggest that ultrasonographic measurements of optic nerve sheath diameter  correlate with signs of raised  intracranial pressure.  Hansen and Helmke showed that intrathecal infusion of lactated ringer’s solution leads to an increase in ONSD measured by ultrasonography.[2]

ONSD  is measured at three millimetres  behind the ocular globe , as the optic nerve is surrounded by fat and  the dural sheath is distensible within its fatty environment, particularly in case of raised  pressure in the cerebrospinal fluid.[3]

A study by Gautam et al. (2019) Conducted a study  wherein  use of caudal block and its effect on ONSD in  children of various age groups were recorded  and compared . He found that there was  high success rate with the technique especially in children younger than 5 years of age

A study by lee et al. found that caudal block with a high volume of local anaesthetic can cause greater increase in Intra Cranial Pressure than caudal block with low volume of local anaesthetic

There has been ultrasonographic evidence of bidirectional movement of CSF, coined  as the “CSF rebound mechanism”. When a considerable volume is shifted from spinal canal  to intracranial space, this volume should increase ICP to such a degree that it affects cerebral perfusion. As CSF is rebounded from intra cranial space to the spinal canal,  the cerebral perfusion should return towards baseline. Thus, helping  us in investigate  whether such changes in cerebral perfusion are associated with high volume caudal block. As ONSD is the direct reflection of intra cranial pressure, we decided  to use it as a marker.

As all these  studies suggest that the use of caudal block can lead to a increase in ONSD in children, but the effect may vary depending on the volume and concentration of local anaesthetic used and the age of child. Therefore, we decided to compare the effect of high volume and low volume Bupivacaine on intra cranial pressure after giving caudal block in paediatric  population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • ASA I AND ASA II Patients scheduled for elective surgeries posted for urological and lower abdominal procedures suitable for caudal anaesthesia.

排除标准

  • 1.Parental / Guardian Refusal 2.Variation In Ultrasonographic Sacral Anatomy 3.Intracranial and Intraocular pathology 4.ACcute Neurological Disease 5.Bleeding diathesis 6.Open Fontanelles
  • SURGERIES IN PRONE/ LITHOTOMY/ LATERAL POSITION.

结局指标

主要结局

To compare the effect of two different volumes of the same drug given intra operatively after giving caudal block and measuring optic nerve sheath diameter by checking ultrasonographically.

时间窗: Time intervals to be measured are as follows: | T0- Baseline - Before Giving Caudal Block | T1- Immediately After Giving Caudal Block | T2- 15 minutes After Giving Caudal Block | t3- 30 minutes After Giving Caudal Block

次要结局

  • Haemodynamic parameter throughout the entirety of operation(intra operatively before caudal (t0), immediately after caudal(t1), 15 mins after caudal(t2), 30 mins after caudal (t3))

研究者

发起方
Dr Ashneil Kohli
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Ashneil Kohli

Bharati Vidyapeeth Deemed To Be University

研究点 (1)

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