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临床试验/CTRI/2025/02/080326
CTRI/2025/02/080326尚未招募4 期

Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing lower abdominal and lower limb surgery A prospective randomise single-blind study

Chettinad Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月18日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare haemodynamic stability of both groups.

研究概览

简要总结

Introduction :

Spinal anaesthesia is a commonly used and an effective technique which provides rapid and reliable anaesthesia with muscle relaxation for patients undergoing lower abdominal surgery and lower limb surgery Spinal anaesthesia is routinely used to provide anaesthesia for elective and emergency surgeries Intensity and duration of spinal block is influenced by numerous factors like height, weight,dose of local anaesthetics drug and anatomy of spine. There are no studies done comparing the effect of fractionated dose versus bolus dose injection in spinal anaesthesia using 0.5% bupivacaine plus buprenorphine in patients undergoing lower abdominal surgeries.

OBJECTIVES

Primary Objective :

To compare haemodynamic stability between two groups.

Secondary Objective :

To assess time of onset and highest level of motor and sensory block.

STUDY DESIGN

A prospective randomized controlled single blind study.

SAMPLE SIZE

Sample size is calculated for the two independent study group for continuous variables for randomised control trial. 20 samples in each group was taken and total sample size will be 40.

MATERIALS AND METHODS

Inclusion criteria:

American society of anesthesiologist (ASA) I -III

Age 18 - 40yrs

Scheduled for lower abdominal surgeries under spinal anaesthesia

Exclusion criteria :

Patient refusal

History of allergy to study drug

Post spinal surgeries,

Spinal deformities

Skin sepsis in lumbar region

Patients with pre-existing neurological disorders

Coagulopathy

Major hepatic, renal and cardiovascular dysfunction

Weight <60kgs and >110kg .

METHODOLOGY

In the preoperative assessment detailed history and physical examination, baseline data like pulse rate, blood pressure, SpO2  and basic investigations will be collected. Informed and written consent will be obtained. The enrolled subjects will be randomized into the 2 study groups using computer generated randomisation code. Patients will not be informed which group will be receiving the fractionated dose and bolus dose.Single blinding is done to avoid patient bias in assessing the objectives.All the patients will receive Tab Alprazolam 0.5mg HS and Tab Ranitidine 150mg HS at 6Am in the morning of surgery. On arrival in Pre-op area an IV access with 18G IV cannula will be secured and RL will be started.  SA was given in sitting position with the  26 guage Quincke spinal needle in L3  - L4 or L4- L5 interspace after skin infiltration with lignocaine. After aspiration of cerebrospinal fluid, injection bupivacaine 0.5% heavy plus buprenorphine was injected according to respective groups, B and F (group B – bolus dose group F – fractionated dose) Group B patients will receive a single bolus dose of bupivacaine + buprenorphine over 10 s.Group F patients will recieve fractionated dose of bupivacaine  + buprenorphine with two-third of the total calculated dose goven initially followed by one-third dose after 60 sec.Both will be given at the rate of 0 2ml/s.After injection of initial two-third dose , the syringe was kept attached to the spinal needle for remaining 60s , after which remaining one-third dose was administered. The number of hypotensive episodes and the use of Inj.Ephedrine will be recorded and time of onser of motor and sensory block will be recorded. The tests will be performed every 5 minutes till the achievement of maximum sensory and motor block (Bromage scale 3) and every 30 min post-operatively  until the sensory and motor variables were back to normal. The onset of sensory blockade will be considered as loss of cold sensation at T10 level and highest level of sensory blockade will be noted. The onset of motor blockade will be evaluated using modified bromage score of 2.

REFERENCES

  1. Jigisha prahaladray Bandheka, Vrinda pravinbhai oza, Ashutosh Vyas, Deepika baria, Poonam

Nehra, Thomas babu.comparsio fractionated dose versus bolus dose injection in spinal

anaesthesia for patients undergoing elective caesarean section: A randomised double blinded

study.

  1. Vanagondi Siva Kumar, Manjula V ramsali, vankayapati Sarada Devi, Kulkarni Dilip Kumar,Pasapuleti surender. Fractionated d vs conventional method of drug administration in spinal

anaesthesia for pregnant women undergoing caesarean section- a comparative study.

..

  1. Nakul Srivastava , Pallavi Ahluwalia , G S Jheetay , Gurpartap Singh. Bolus dose versus

fractionated dose injection of hyperbaric bupivacaine in spinal anaesthesia among adult

patients undergoing lower limb surgery : A prospective study.

  1. Pooja Derakhshan ,Seyed Hamid Rena Faiz,Poupak Rahimzadeh,Reza Salehi and Ghazaleh

Khaled.A comparison of the effect of Fractionated and Bolus dose injection on Spinal

anaesthesia for lower limb surgery : A randomised clinical trial

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1.American society of anaesthesiologist (ASA) grade I.
  • III 2.Age
  • 40yrs 3.Scheduled for lower abdominal surgeries under spinal anaesthesia.

排除标准

  • 1.Patient Refusal 2.History of allergy to study drug
  • Post spinal surgeries 4.spinal deformities 5.skin sepsis in lumbar region.
  • 6.Patients with pre-existing neurological disorders 7.Coagulopathy 8.Major hepatic,renal and cardiovascular malformation 9.Weight less than 60kg and more than 110kgs.

结局指标

主要结局

To compare haemodynamic stability of both groups.

时间窗: 6 Hours

次要结局

  • Assessing the time of onset and highest level of motor and sensory block.(6hours)

研究者

发起方
Chettinad Hospital and Research Institute
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Akalya Jayapal

Chettinad Hospital And Research Institute

研究点 (1)

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