FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071551 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparison of two different spinal techniques in surgeries below umbilicus. 
Scientific Title of Study   A comparison of efficacy and saftey of fractional spinal anaesthesia versus conventional spinal anaesthesia with 0.5 percent hyperbaric bupivacaine and fentanyl in patients undergoing infra umbilical and lower limb surgeries. 
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 SHREYA VEKARIYA 
Designation  ANAESTHESIOLOGY 1ST YEAR PG RESIDENT 
Affiliation  GMERS MEDICAL COLLEGE AND HOSPITAL 
Address  Anesthesia department, Civil hospital, GMERS gandhinagar.

Gandhinagar
GUJARAT
382016
India 
Phone  9429786682  
Fax    
Email  shreyavekaria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR HINA GADANI 
Designation  ANAESTHESIOLOGY ASSOCIATE PROFESSOR 
Affiliation  GMERS MEDICAL COLLEGE AND HOSPITAL 
Address  Anesthesia department, Civil hospital, GMERS gandhinagar.

Gandhinagar
GUJARAT
382016
India 
Phone  8690501339  
Fax    
Email  hinagadani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR HINA GADANI 
Designation  ANAESTHESIOLOGY ASSOCIATE PROFESSOR 
Affiliation  GMERS MEDICAL COLLEGE AND HOSPITAL 
Address  Anesthesia department, Civil hospital, GMERS gandhinagar.

Gandhinagar
GUJARAT
382016
India 
Phone  8690501339  
Fax    
Email  hinagadani@gmail.com  
 
Source of Monetary or Material Support  
GMERS Medical College And Hospital Sector 12 Pathikashram road Gandhinagar, India Pin code- 382016 
 
Primary Sponsor  
Name  GMERS Medical College And Hospital Gandhinagar 
Address  Sector 12 Pathikashram road Gandhinagar - India Pin code - 382016 
Type of Sponsor  Government 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 Shreya Vekariya  GMERS Medical College And Hospital Gandhinagar  1st floor Anaesthesia department 600 Bed hospital building Sector 12 Pathikashram road Gandhinagar, India Pin code- 382016
Gandhinagar
GUJARAT 
9429786682

shreyavekaria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee GMERS Medical College, Gandhinagar  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  Conventional spinal anaesthesia  Conventional spinal anesthesia is a type of regional anesthesia commonly used for surgeries involving the lower half of the body Conventional patients will be administered a single bolus dose of 3.5 ml (3.0 ml i.e. 15 mg hyperbaric bupivacaine + 0.5 ml i.e. 25 mcg fentanyl) Patient will be turned to supine position soon after the completion of spinal anaesthesia injection. This intervention require 6 to 7 months. 
Intervention  Fractional spinal anaesthesia  Fractional spinal patients will be administered a fractionated dose of 3.5 ml (3.0 ml i.e. 15 mg hyperbaric bupivacaine + 0.5 ml i.e. 25 mcg fentanyl) with 2.4 ml of the total dosage given initially, the syringe will be kept attached to the spinal needle for remaining 90 seconds, after which remaining dose, i.e. 1.1 ml will be administered. Patient will be turned to supine position soon after the completion of spinal anaesthesia injection. This intervention require 6 to 7 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiology (ASA) Grade I & II
weight: 50 – 80 Kgs.
height: 150 – 170 cms
Patients posted for infra-umbilical and lower limb surgery 
 
ExclusionCriteria 
Details  Patient refusal for study
Patient with clinically significant Coagulopathy
Patient with spine deformities
Patients with infection at site of Spinal Injection
Patients with associated systemic diseases e.g. hypertension, diabetes mellitus, kidney diseases,
respiratory diseases, cardiovascular diseases, liver disease.
Patients with history of allergy to local anaesthetics and opioids
Pregnant and lactating females
Patients who have history of drug abuse
Psychologically challenged patients
Non cooperative patient 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To compare the intra-operative hemodynamic changes in fractional spinal anaesthesia and
conventional spinal anaesthesia (Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean
Arterial Blood Pressure, SpO2%).
2. To compare the sensory blockade parameters (time of onset of sensory blockade, time of peak
level of sensory blockage and duration of sensory blockade) between fractional spinal anaesthesia and
conventional spinal anaesthesia.
3. To compare the motor blockade parameters (time of onset of motor blockade, duration of motor
blockade) between fractional spinal anaesthesia and conventional spinal anaesthesia .
4. To compare the duration of analgesia between fractional spinal anaesthesia and conventional
spinal anaesthesia. 
2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To study side effects in patients undergoing fractional spinal anaesthesia and conventional spinal
anaesthesia. 
2 years 
 
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   Phase 4 
Date of First Enrollment (India)   12/08/2024 
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="2"
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  
Spinal anaesthesia is usually performed anaesthesia technique for infraumbilical and lower limb surgeries. It provides sensory as well as motor blockade. Spinal anaesthesia continues to dominate the field of anaesthesiology because of its rapid onset, simplicity and low complications compared to general anaesthesia. Multiple local anaesthetic agents were used over a period of time. Hyperbaric Bupivacaine 0.5% being the most used one due to its longer duration of action and addition of adjuvant further increased the duration of spinal anaesthesia. Different adjuvants cause different changes in hemodynamic parameters, sensory blockade, motor blockade and analgesia. Fentanyl is a synthetic opioid drug, which is most commonly added as an adjuvant in intrathecal injection because it is more potent, providing better analgesia, hemodynamic stability with better safety profile.

Spinal anaesthesia causes a sympathetic denervation resulting in hypotension because of the rapid sympathetic block.In the conventional technique of spinal anaesthesia bolus dose of drug which many a times gives higher level of anaesthesia than the desired, thus causes more hypotension. In comparison to this, if the drug is administered in two or more divided doses (fractionated doses) in the subarachnoid space rather than entire dose being injected as one dose, occurence of hypotension is reduced. 

Fractional spinal anaesthesia technique has been recently introduced. In fractional technique of spinal anaesthesia, after giving 1st fractionated dose , the drug will settle down as the patient to be kept in sitting position for 30-90 seconds, so desired and predicted sensory and motor blockade to be achieved. Then after 2nd fractionated dose is injected and after giving 2nd fractionated dose the patient to be made supine which leads to slow distribution of the drug which prevents hypotention and provides better hemodynamic stability. Fractional spinal anaesthesia is used for a number of surgical procedures because of more hemodynamic stability, longer duration of sensory and motor blockade and longer duration of analgesia in camparison to conventional spinal anaesthesia.

Few studies have been done and published comparing both of these techniques, fractional v/s conventional spinal anaesthesia. Both of these techniques of spinal anaesthesia are used interchangeably in our institute. But, the data collection on comparing both of these techniques has not been done previously. The data being collected from this study, might be helpful for establishing some beneficial and advanced/recent protocol in the anaesthesia department, thereby to the institute and anaesthesia society also. So, the present study will be conducted to compare the efficacy and safety of fractional spinal anaesthesia v/s conventional spinal anaethesia using hyperbaric bupivacaine 0.5% (3ml–15mg) as a local anaesthetic and fentanyl (0.5ml-25mcg) as an adjuvant in patients of infraumbilical and lower limb surgeries.
 
Close