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CTRI Number  CTRI/2023/05/052154 [Registered on: 01/05/2023] Trial Registered Prospectively
Last Modified On: 29/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of two drugs given in spine area in patients posted for surgery in lower abdomen and lower limbs 
Scientific Title of Study   Comparative evaluation of intrathecal hyperbaric levobupivacaine and ropivacaine with fentanyl as adjuvant in elective infraumbilical surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Seema Jindal 
Designation  Associate Professor 
Affiliation  Baba Farid university of Health Sciences Faridkot 
Address  Department of Anaesthesiology, Guru Gobind Singh Medical college and Hospital Faridkot

Faridkot
PUNJAB
151203
India 
Phone    
Fax    
Email  jindalseema77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Jindal 
Designation  Associate Professor 
Affiliation  Baba Farid university of Health Sciences Faridkot 
Address  Department of Anaesthesiology, Guru Gobind Singh Medical college and Hospital Faridkot

Faridkot
PUNJAB
151203
India 
Phone    
Fax    
Email  jindalseema77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prerna 
Designation  PG student 
Affiliation  Baba Farid university of Health Sciences Faridkot 
Address  Department of Anaesthesiology, Guru Gobind Singh Medical college and Hospital Faridkot

Faridkot
PUNJAB
151203
India 
Phone    
Fax    
Email  prernasingh6261@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Guru Gobind Singh Medical College and Hospital Faridkot 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Department of Anaesthesiology, Guru Gobind Singh Medical College and Hospital Faridkot 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Seema Jindal  Guru Gobind Singh Medical College and Hospital Faridkot  Department of anaesthesiology main operation theater complex, 2nd floor
Faridkot
PUNJAB 
9646050485

jindalseema77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee GGS Medical college and Hospital Faridkot  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 
Intervention  0.5% hyperbaric levobupivacaine and 0.75 % hyperbaric ropivacaine  3.5 ml of drug containing either levobupivacaine or ropivacaine with fentanyl will be given intrathecal and onset and duration of sensory block will be studied 
Comparator Agent  hyperbaric levobupivacaine with fentanyl versus hyperbaric ropivacaine with fentanyl  in one group patients will receive hyperbaric levobupivacaine and fentanyl. in other group patients will receive hyperbaric ropivacaine with fentanyl in spinal anaesthesia for infraumbilical surgeries 
Comparator Agent  In Group 2:- patients will receive hyperbaric ropivacaine with fentanyl  3.5 ml of drug containing hyperbaric ropivacaine will be given by intrathecal route 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American society of anaesthesiology grade I and II patients scheduled for elective infraumbilical surgeries under spinal anaesthesia 
 
ExclusionCriteria 
Details  1. patients with known allergy to any of the study drugs
2. patients with coagulation disorders and on anticoagulants
3. patients with local skin infection or disease
4. patients with previous spine surgery or spine abnormality 
 
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 
onset and duration of sensory block  from time of injection of drug till loss of sensation at T6 dermatome which will be checked every 2 minutes till 20 min and then every 10 min till highest level attained 
 
Secondary Outcome  
Outcome  TimePoints 
onset and duration of motor block  every 5 minutes for 30 minutes and then every 15 minutes till recovery of motor blockade to modified bromage score of zero 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/05/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The present study will be conducted in department of Anaesthesiology, GGS medical college and hospital Faridkot on 100 patients scheduled for infraumbilical surgeries under spinal anaesthesia. The patients will be divided into two groups as under:-
Group L- patiens will receive 3.5 ml of drug containing o.5% levobupivacaine and 25 mcg of fentanyl.
Group R- patiens will receive 3.5 ml of drug containing o.75% Ropivacaine and 25 mcg of fentanyl.
After administration of study drug onset of sensory and motor blockade will be assessed. Segmental sensory level of anaesthesia will be assessed by patient s response to pin prick every 2 min till 20 min and then every 10 min till highest level is achieved. time of onset of sensory block will be noted. Time of sensory block regression will be assessed from maximum block height attained to regression till L1 dermatome. Duration of sensory block is defined as time from intrathecal injection to regression of pin prick sensation to L1 dermatome. Motor block will be assessed every 5 min for 30 min and then every 15 min till recovery of motor blockade to modified bromage score of zero. Time of regression of motor block will be assessed from modified bromage score of 3 to zero. Duration of motor block is defined as time from intrathecal injection to regression of motor block to bromage score of zero.Intraoperative pulse rate, mean arterial blood pressure and oxygen saturation will be recorded every 2 min till 20 min and then every 5 min till end of surgery. Any side effects like nausea, vomiting, pruritis, bradycardia or hypotension will be recorded. In the post operative period the time to first analghesic demand will be noted and patient will be given rescue analgesia in the form of injection diclofenac sodium 1.5 mg/kg IV (intravenous) if VAS >3 and requirement of same will be noted for 24 hours. After completion of study, observations obtained will be tabulated and analysed using appropriate statistical methods.
 
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