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CTRI Number  CTRI/2025/02/081468 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparing Bolus vs Fractionated Dose Spinal Anesthesia for Lower Limb Surgery 
Scientific Title of Study   A prospective study to compare the efficacy of bolus dose versus fractionated dose injection of hyperbaric bupivacaine with dexmedetomidine in spinal anaesthesia among adult patients undergoing lower limb surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aayushi Godara 
Designation  Resident doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department,2nd Floor,General ot Complex, Dhiraj Hospital,Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Wagodhiya,Piparia, Vadodara, GUJARAT 391760. India

Vadodara
GUJARAT
391760
India 
Phone  9737666774  
Fax    
Email  aayushigodara1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SARA MARY THOMAS 
Designation  Head Of Department and professor  
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department,2nd Floor,General ot Complex Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Wagodhiya,Piparia, Vadodara GUJARAT 391760. India

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SARA MARY THOMAS 
Designation  Head Of Department and professor  
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department,2nd Floor,General ot Complex Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Wagodhiya,Piparia, Vadodara GUJARAT 391760. India

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Source of Monetary or Material Support  
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode 391760 
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen 
Address  Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode 391760. 
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 
DrAayushi Godara   Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre  2nd floor,General Ot Complex,Anaesthesia Department,Dhiraj hospital,Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Sumandeep Vidyapeeth Waghodia,Pipariya Vadodara GUJARAT 391760
Vadodara
GUJARAT 		 9737666774

aayushigodara1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  fractionated dose Of 3.8ml TWO THIRD of total dose 2.5ml will be given initially and after 90sec remaining 1/3rd of total dose i.e. 1.3ml will be given.  Patients will be positioned in the sitting position. Painting of patients back will be done with povidone iodine solution followed by draping. Under all aseptic precautions 25 G Quincke needle will be inserted in the midline at L3 L4 interspace. After free flow of cerebrospinal fluid spinal fractionated dose of 3.8ml TWO THIRD of total volume 2.5ml will be given initially the syringe will be kept attached to the spinal needle for 90sec after which remaining TWO THIRD of total volume 1.3ml will be administered. Both bolus and fractional dose will be administered at a rate of 0.2ml PER SEC The patient will be placed supine immediately after injection.  
Intervention  single bolus dose of 3.8ml Of spinal drug.  Patients will be positioned in the sitting position. Painting of patients back will be done with povidone iodine solution followed by draping. 25 G Quincke needle will be inserted in the midline at L3 L4 interspace. After free flow of cerebrospinal fluid single bolus dose of 3.8 ml of spinal drug will be administered The patient will be placed supine immediately after injection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient willing to sign the written informed consent.
Patients belonging to American Society of Anaesthesiologists (ASA) Grade I or II.
•Male or female patients between age range of 18- 60 years.
Patients undergoing elective lower limb surgeries under spinal anaesthesia
 
 
ExclusionCriteria 
Details  •Patients unwilling to participate in the study.
•Patient having arryhthmia or heart block.
•Patients with renal, hepatic, cardiovascular and respiratory diseases.
•Patients belonging to ASA Grade III or more.
•Pregnant or lactating women.
•History of known allergy to study drug.
•Patients who needs supplementation of general anaesthesia.
•Any contraindication to spinal anaesthesia (local site infection , coagulation disorder, raised intracranial pressure , hemodynamic instability, neurological disorders).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The study will help us to know which group provides longer duration of sensory and motor blockade and also which provides better hemodynamic stability  sensory and motor block will be assessed every 2 minutes interval and onset of sensory and motor blockade will be noted and highest level of sensory block will be assessed
sensory will be assessed every 30 min till regression to L1
motor blockade will be assessed till modified bromage score is 0

HR,SBP,DBP,MAP,SPO2 will be assessed at 0 min,3 min, 5 min, 10 min, 15 min, 30 min, 45min,60min,75min,90min, 120min, 150min, 180min  
 
Secondary Outcome  
Outcome  TimePoints 
which method of spinal anaesthesia,will provide longer post operative analgesia in patient undergoing lower limb surgery  VAS SCORE:- 0,60,90,120,180 min
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   10/03/2025 
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="6"
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   A PROSPECTIVE STUDY TO COMPARE THE EFFICACY OF BOLUS DOSE VERSUS FRACTIONATED DOSE INJECTION OF HYPERBARIC BUPIVACAINE WITH DEXMEDETOMIDINE IN SPINAL ANAESTHESIA AMONG ADULT PATIENTS UNDERGOING LOWER LIMB SURGERY

Aim
To compare the efficacy of bolus dose versus fractionated dose injection of hyperbaric bupivacaine with dexmedtomidine in spinal anaesthesia among adult patients undergoing lower limb surgery.

OBJECTIVES

1.  To compare the onset of sensory and motor blockade in fractional spinal anaesthesia and conventional spinal anaesthesia and the highest level of sensory block achieved in both groups.

 

2.    To compare the duration of sensory and motor block in both the groups

 

3  .  To compare the changes in Heart Rate,Blood Pressure & Saturation between the groups.

 

4.   To compare duration of analgesia in both the groups


INCLUSION CRITERIA:

·       Patient willing to sign the written informed consent.

·       Patients belonging to American Society of Anaesthesiologists (ASA) Grade I or II.

·       Male or female patients between age range of 18- 60 years.

·       Patients undergoing elective lower limb surgeries under spinal anaesthesia

 

EXCLUSION CRITERIA:

·      Patients unwilling to participate in the study.

·      Patient having arryhthmia or heart block.

·      Patients with renal, hepatic, cardiovascular and respiratory diseases.

·      Patients belonging to ASA Grade III or more.

·      Pregnant or lactating women.

·      History of known allergy to study drug.

·      Patients who needs supplementation of general anaesthesia.

·             Any contraindication  to spinal anaesthesia (local site infection , coagulation disorder , raised intracranial pressure , hemodynamic instability, neurological disorders).


Patients will be randomly allocated using computer generated random numbers into 2 groups ; Group B And Group F of 30 patients each . In both groups the total volume of drug administered during spinal anaesthesia will be 3.8ml [3.7ml (18.5mg) of 0.5% hyperbaric bupivacaine + 0.1ml (10mcg) of dexmedetomidine.]


Group B:- Patients will be administred single bolus dose of 3.8ml Of spinal drug.

Group F:- Patients will be administered fractionated dose Of 3.8ml i.e 2/3 rd of total dose - 2.5ml will be given initially and 

after 90sec remaining 1/3rd of total dose i.e. 1.3ml will be given.

               All patients of both groups will be monitored for:

HR, SBP, DBP, MAP, SPO2, , will be monitored at 1min, 3min, 5 min, 10 min,

15 min and thereafter every 15 minutes upto 90 minutes and then every 30 minutes till the end of surgery.


              Sensory block will be assessed at 2 minute interval until two consecutive levels of sensory block will be identical (i.e fixation of the level); which will be taken as the highest level of sensory block. After this, assessment of sensory block will be 

done every 30 minutes till level regresses to L1.


Onset of motor block of drug (time from intrathecal injection till achievement of Bromage Score 1) and duration of motor block 


(time from intrathecal injection of drug to return of Bromage Score to 0) will be recorded.

 VAS will be assessed every 30min for 2 hours and then every hourly till VAS becomes ≥4

Site of Study: Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Duration- The study will be completed within 18 months after obtaining the approval from institutional ethics committee .

Study Design- Prospective, Observational Study.

 statistical method - data collected will be tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percent. As regard to numerical variables; tests like unpaired student – t test and or ANOVA will be used whenever appropriate for between- groups comparisons, while for categorical variables; chi – square test will be used. p value<0.05 will be considered statistically significant.


LIKELY OUTCOME/BENEFITS OF STUDY The study will help us to know which method of spinal anaesthesia,will provide better hemodynamical stability,longer duration of sensory and motor block and provides longer post operative analgesia in patient undergoing lower limb surgery.

 

 


 
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