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CTRI Number  CTRI/2024/07/071076 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) 
Study Design  Other 
Public Title of Study   A comparative study of ropivacaine with fentanyl in spinal regional anaesthesia in elective lower segment caesarean section surgeries. 
Scientific Title of Study   A comparative of intrathecal isobaric ropivacaine 0.5 percent with fentanyl versus isobaric ropivacaine 0.5 percent in elective lower segment caesarean section 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  Ayush Satishkumar Gupta 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi Medical College and Hospital, Jaipur 
Address  Mahatma Gandhi University of Medical Sciences and Technology RIICO Institutional Area Sitapura, Tonk Road,

Jaipur
RAJASTHAN
302022
India 
Phone  7405224060  
Fax    
Email  drayushgupta05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Isha Bijarnia 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Hospital, Jaipur 
Address  Mahatma Gandhi University of Medical Sciences and Technology RIICO Institutional Area Sitapura, Tonk Road,

Jaipur
RAJASTHAN
302022
India 
Phone  8107324518  
Fax    
Email  Silayachisha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ayush Satishkumar Gupta 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi Medical College and Hospital, Jaipur 
Address  Mahatma Gandhi University of Medical Sciences and Technology RIICO Institutional Area Sitapura, Tonk Road,

Jaipur
RAJASTHAN
302022
India 
Phone  7405224060  
Fax    
Email  drayushgupta05@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area Sitapura, Tonk Road, Jaipur, Rajasthan India -n302022  
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Hospita 
Address  RIICO Institutional Area Sitapura, Tonk Road, Jaipur RAJASTHAN 302022 India  
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 
Dr Ayush Satishkumar Gupta  Mahatma Gandhi Medical college and Hospital  Department of Anaesthesia, Operation Theatre Complex
Jaipur
RAJASTHAN 
7405224060

drayushgupta05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, Mahatma Gandhi University of Medical Sciences and TechnologyJaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Isobaric Ropivacaine  Group R Injection Ropivacaine 0.5% + Normal saline 0.5ml total volume of 2.5 ml will be using in intrathecal subarachnoid block. Intervention time will be less than 10 minutes and will observe patients hemodynamic parameters with pain score for up to 6 hours .  
Comparator Agent  Isobaric Ropivacaine + Fentanyl  Group RF Injection Ropivacaine 0.5% + Injection Fentanyl 25mcg (0.5ml) total volume of 2.5 ml will be using in intrathecal subarachnoid block. Intervention time will be less than 10 minutes and will observe patients hemodynamic parameters with pain score for up to 6 hours .  
Intervention  SUBARCHNOID BLOCK  INTRATHECAL DRUG ADMISNTRATION 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) ASA physical status I-II
2) Pregnant females scheduled for elective lower
segment C section surgeries  
 
ExclusionCriteria 
Details  1)Patient with known psychiatric disorders,
2)Coagulopathy disorders
3)Infection at the site of block placement
4)Morbid obesity
5)Known Drug Allergie
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
A comparassion intrathecal isobaric ropivacaine 0.5% with fentanyl v/s isobaric ropivacaine 0.5% in elective lower segment caesarean section surgeries to study duration of analgesia,  at baseline ,at the time od induction of anaesthesia, after 1minutes of induction, 5minutes, 10minutes, 20 minutes, 30 minutes, 60minutes, 90 minutes, 120 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Time of onset, time to achieve maximum level and duration of sensory block. Time of onset and duration of motor block.Postoperative pain assessment (VAS score) and total analgesic requirement in the first 24 hours in two groups.
To assess the side effects like nausea, vomiting, pruritis etc.
 
post-operatively 15 min, 1hr and 2 hr.
Time of onset sensory and motor
2 Segment regression sensory and motor.

 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   05/08/2024 
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="0"
Months="2"
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  
  • Subarachnoid block is the most widely used regional anaesthetic procedure for lower abdominal and lower limb surgery including lower segment caesarean section (LSCS). It provide rapid onset, consistent sensory and motor blockade with adequate muscle relaxation and for all types of surgery below the level of umbilicus. Regional anaesthesia is safer than general anaesthesia and having advantage of the parturient being awake during the birth process. Intrathecal local anaesthetics (LA) alone are not enough for effective postoperative analgesia and higher dose of LA are also associated with haemodynamic instability, which can lead to unfavourable maternal and foetal outcome. So far, many adjuvants have been used to augment the analgesia produced by intrathecal LA and to reduce their adverse effects. It has been well documented that the combination of fentanyl and LA administered intrathecally has synergistic analgesic effects. Fentanyl is a lipophilic j-receptor opioid agonist. Intrathecally, fentanyl exerts its effect by combining with opioid receptors in the dorsal horn of spinal cord and may have a supra spinal spread and action.Hyperbaric bupivacaine (0.5%), an amide-type of local anaesthetic, has been the gold standard for intrathecal use in spinal anaesthesia for many years but also has been associated with severe hypotension, delayed recovery of motor block, and cardiotoxicity when used in large concentration or when accidentally administered intravascularly. The introduction of ropivacaine has a better margin of safety for local anaesthetic systemic toxicity. Various studies have evaluated the effectiveness of these newer drugs for spinal anaesthesia using hyperbaric and isobaric solutions with a reliable rate of success. The study includes 140 pregnant patients aged, ASA grade I, and II scheduled for surgeries under subarachnoid block enrolled in this study and allocated into two groups of 70 patients each.  After shifted to the operating room, standard ASA monitoring was attached.  Group RF-  received intrathecally 0.5% Isobaric Ropivacaine (2.0 ml) +25mcg(0.5ml) fentanyl Group R- received intrathecally 0.5% Isobaric Ropivacaine (2.0 ml)+ 0.5ml NS 0.9Parameters noted were Hemodynamic parameters were recorded,immediately after administration of intrathecal drugs, 1 min, 3 min, 5 min, 10 min, 15 min, 30 min, 60 min, 90 min and 120 min after administration of intrathecal drugpost-operatively 15 min, 1hr and  2 hr. Time of onset, time to achieve maximum level and duration of sensory block noted &Time of onset and duration of motor block notedPostoperative pain was assessed by the VAS  scale and total analgesic requirement in the first 24 hours in two groups.Rescue Analgesia IV Diclofeneac 75mg IV SoS. 



 
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