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CTRI Number  CTRI/2025/02/080326 [Registered on: 11/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare divided dose vs one single dose of drug injected into the spinal area to evaluate haemodynamic stability of patients undergoing lower abdominal surgeries and lower limb surgeries 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akalya Jayapal 
Designation  Postgraduate Resident 
Affiliation  Chettinad Hospital And Research Institute 
Address  Akalya Jayapal, postgraduate Resident, D- block, 1st floor, Department of Anaesthesiology, Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  8056894214  
Fax    
Email  akalyajs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Kulasekhar 
Designation  Professor Head Of Department 
Affiliation  Chettinad Hospital And Research Institute 
Address  Professor , Head of Department,D- block, 1st floor, Department of Anaesthesiology, Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9840498420  
Fax    
Email  ashokk_dr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Akalya Jayapal 
Designation  Postgraduate Resident 
Affiliation  Chettinad Hospital And Research Institute 
Address  Akalya Jayapal , Postgraduate Resident, D- block, 1st floor, Department of Anaesthesiology, Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  8056894214  
Fax    
Email  akalyajs@gmail.com  
 
Source of Monetary or Material Support  
Chettinad hospital and research institute Chettinad health city SH 49 A, Kelambakkam,Tamilnadu ,India -603103 
 
Primary Sponsor  
Name  Chettinad Hospital and Research Institute 
Address  Chettinad Hospital and Research Institute,Chettinad Health City,Rajiv Gandhi Salai,Kelambaakam ,Tamilnadu ,India-603013 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akalya Jayapal  Chettinad Hospital and Research Institute  D-Block, 1st Floor, Department Of Anaesthesiology, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU 
8056894214

akalyajs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE(CARE IHEC -1)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bolus dose injection of bupivacaine and buprenorphine.  Bolus dose injection in spinal anaesthesia for patients undergoing lower abdominal surgeries and lower limb surgeries and compare haemodynamic stability and to assess time of onset and highest level of motor and sensory block. 
Intervention  Fractionate dose injection of bupivacaine and buprenorphine.  Fractionated dose injection in spinal anaesthesia for patients undergoing lower abdominal surgeries and lower limb surgeries and compare haemodynamic stability and to assess time of onset and highest level of motor and sensory block.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.American society of anaesthesiologist (ASA) grade I - III 2.Age 18 - 40yrs 3.Scheduled for lower abdominal surgeries under spinal anaesthesia 
 
ExclusionCriteria 
Details  1.Patient Refusal 2.History of allergy to study drug 3. 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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare haemodynamic stability of both groups.  6 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the time of onset and highest level of motor and sensory block.  6hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   18/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.

2. 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.
..
3. 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.

4. 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
 
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