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CTRI Number  CTRI/2024/03/064520 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of two drugs used for giving spinal anaesthesia to perform surgeries below the level of umbilicus. 
Scientific Title of Study   Comparison of clinical efficacy of hyperbaric levo-bupivacaine (0.5%) with hyperbaric ropivacaine(0.75%) in infraumbilical surgeries under spinal anaesthesia. 
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 Manoj Panchal 
Designation  Junior Resident 
Affiliation  Pandit BD Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care Modular OT Complex, 2nd Floor, PGIMS Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9729350835  
Fax    
Email  monupanchal087@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Susheela Taxak 
Designation  Senior Professor 
Affiliation  Pandit BD Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, Modular OT Complex, 2nd Floor, PGIMS Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9896067416  
Fax    
Email  susheelataxak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manoj Panchal 
Designation  Junior Resident 
Affiliation  Pandit BD Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, Modular OT Complex, 2nd Floor, PGIMS Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9729350835  
Fax    
Email  monupanchal087@gmail.com  
 
Source of Monetary or Material Support  
Pandit B. D. Sharma PGIMS District - Rohtak State - Haryana Pin - 124001 Country - India 
 
Primary Sponsor  
Name  Pandit BD Sharma PGIMS Rohtak 
Address  Rohtak Haryana Pin 124001 
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 Manoj Panchal  Pandit BD Sharma PGIMS Rohtak  Department of Anaesthesiology and Critical Care, Modular OT Complex, 2nd Floor, PGIMS Rohtak.
Rohtak
HARYANA 		 9729350835

monupanchal087@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS/UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V039||Pedestrian injured in collision with car, pick-up truck or van, unspecified whether traffic or nontraffic accident,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hyperbaric levo-bupivacaine (0.5%)  3 ml of drug hyperbaric levo-bupivacaine (0.5%) will be administered into subarachnoid space and patient will be assessed for the study parameters intraoperatively and postoperatively till patient complains of pain. 
Comparator Agent  Hyperbaric ropivacaine (0.75%)  3 ml of drug hyperbaric ropivacaine (0.75%) will be administered into subarachnoid space patient will be assessed for the study parameters intraoperatively and postoperatively till patient complains of pain. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade 1 and Grade 2 patients posted for infraumbilical surgeries. 
 
ExclusionCriteria 
Details  Age less than 18 years and more than 60 years.
ASA Grade 3 and above patients.
Patient allergic to the interventional drugs.
Patient not willing to participate in the research.
Patient having any neurological disease linked with brain and spinal cord.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessing the time of onset of sensory blockade and time of onset of motor blockade after subarachnoid injection of the study drugs (hyperbaric levo-bupivacaine and hyperbaric ropivacaine) and comparing the data.  At one minute interval after administation of study drugs till 20 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of the time required for two segments regression & complete regression of sensory blockade & complete regression of motor blockade in the two groups receiving the study drugs & time of first rescue analgesia requirement in the two groups will be done. Haemodynamic variations caused by the study drugs in the two groups will be noted. The quality of post operative analgesia in the two groups will be assessed & any adverse effects caused by the study drugs in the two groups will be noted. Data will be collected & compared.
 		 At baseline , 2 min interval till 10 minutes & then at 15 minutes interval till completion of surgery & postoperative period till patient complains of pain. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/03/2024 
Date of Study Completion (India) 02/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 02/09/2024 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 aimed at comparing the clinical efficacy of two local anaesthetic drugs which have been already marketed in India i.e hyperbaric levobupivacaine (0.5%) and hyperbaric ropivacaine (0.75%) . Study will include two groups of patients with sample size of 30 in each group. Informed and written consent will be taken from each participant. Study will include ASA grade 1 and 2 patients who have been posted for infraumbilical surgeries under spinal anaesthesia. Data will be collected and compared. 
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