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CTRI Number  CTRI/2025/06/088821 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 13/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TO COMPARE FRACTIONATED WITH SINGLE DOSE OF SPINAL ANAESTHESIA IN PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES  
Scientific Title of Study   COMPARISON OF FRACTIONATED WITH BOLUS DOSE OF ZERO POINT FIVE PERCENT HYPERBARIC BUPIVACAINE IN SPINAL ANAESTHESIA FOR PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sakshi Dhingra 
Designation  Post Graduate Junior Resident 
Affiliation  SGT UNIVERSITY 
Address  Department of Anaesthesia and Critical Care,SGT University Budhera, Gurugram , Haryana Gurgaon HARYANA 122505 India

Gurgaon
HARYANA
122505
India 
Phone  9711355379  
Fax    
Email  dhingrasakshi2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Savita Saini 
Designation  Professor Anaesthesia Department 
Affiliation  SGT UNIVERSITY 
Address  Department Of Anaesthesia and Critical Care Budhera, Gurugram, Haryana Gurgaon HARYANA 122505 India

Gurgaon
HARYANA
122505
India 
Phone  9416262343  
Fax    
Email  dr_savitasaini@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Sakshi Dhingra 
Designation  Post Graduate Junior Resident 
Affiliation  SGT UNIVERSITY 
Address  Department Of Anaesthesia and Critical Care Budhera, Gurugram, Haryana Gurgaon HARYANA 122505 India

Gurgaon
HARYANA
122505
India 
Phone  9711355379  
Fax    
Email  dhingrasakshi2@gmail.com  
 
Source of Monetary or Material Support  
SGT University, Chandu budhera, Gurugram , Haryana India Pincode- 122505 
 
Primary Sponsor  
Name  Sakshi Dhingra 
Address  Department of Anaesthesia and Critical Care , SGT University Budhera, Gurugram,Haryana India Pincode- 122505 Haryana 
Type of Sponsor  Other [Self] 
 
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 Sakshi Dhingra  SGT HOSPITAL  Anaesthesia department 1st floor SGT hospital Sgt university Budhera
Gurgaon
HARYANA 		 9711355379

dhingrasakshi2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Faculty of Medicine and Health Sciences , SGT university,INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% Hyperbaric Bupivacaine with 25 mcgs Fentanyl as bolus  3ml of 0.5% Hyperbaric Bupivacaine with 25 mcgs Fentanyl to be given as single bolus dose 
Comparator Agent  0.5% Hyperbaric Bupivacaine with 25 mcgs Fentanyl as fractionated dose  3ml of 0.5% Hyperbaric Bupivacaine with 25 mcgs Fentanyl to be given as fractionated dose 1/2 of drug followed by 1/2 of drug after waiting for 45 seconds  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Physical status I-III according to American Society of Anesthesiologists
2) Willing for spinal anaesthesia
3) Patients undergoing lower limb orthopaedic surgeries
4) BMI less than 35 
 
ExclusionCriteria 
Details  1) Absolute contraindications of spinal anaesthesia such as localized infection at injection site, patient’s inability to position during the procedure , patient’s refusal, allergy to anaesthetic drugs, increased intracranial pressure
2) Relative contraindication to spinal anaesthesia such as myelopathy or peripheral neuropathy, spinal stenosis, history of spinal surgery, spinal deformities, multiple sclerosis, spina bifida, aortic stenosis , altered mental status & coagulopathies.
3) BMI equal to or more than 35
4) Ineffective block with conversion to general anaesthesia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic changes [Mean Arterial Pressure (MAP), Non Invasive Blood Pressure
(NIBP) & Heart Rate (HR)] at different time intervals. 		 The heart rate and blood pressure will be monitored at base line, just before subarachnoid block then at 5,10,15,20,40,60,80,100,120 mins and thereafter every
20 mins till the duration of surgery after giving spinal anaesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
1)Onset and duration of sensory and motor block using pinprick test and modified Bromage scale
2)Duration of analgesia till the first request for rescue analgesic using VAS pain score  		 1)For sensory and motor blockade assessment tests will be performed every 3 mins till the achievement of maximum sensory and motor block(Bromage scale 3) and every 30 minutes later on postoperatively until complete recovery from sensory and motor blockade will be achieved . 2)Pain will be assessed every 30 min initially for the first 2 hours and then 2 hourly for 6 hours and then every 6 hourly for 24 hours or when the patient demands rescue analgesic. 
 
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)   25/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/06/2025 
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  
This study is a comparative randomised double blind study of fractionated with bolus dose of 0.5% hyperbaric bupivacaine with 25 mcgs Fentanyl in spinal anaesthesia for patients undergoing lower limb orthopaedic surgeries. The objective of the study is to compare the haemodynamic changes at different time intervals , onset and duration of sensory and motor block , duration of analgesia till the first request for rescue analgesics and side effects seen among the two groups . Total 60 patients will be randomly selected which belongs to ASA I-III . 60 patients will be divided into two groups 30 in each group by using sealed envelope technique . One group will recieve drug as bolus and other will recieve drug in fractionated manner. The drug will be given to all patients using 25 G Quincke’s spinal needle in sitting position.
 
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