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CTRI Number  CTRI/2025/09/095099 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of pain relief during labour using Ropivacaine alone or with fentanyl through epidural injection 
Scientific Title of Study   A Comparative study of 0 point 1 percent Ropivacaine with or without Fentanyl for Epidural Labour analgesia A Randomized Controlled study 
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 Devendra Verma 
Designation  Senior Professor 
Affiliation  RNT Medical College & MB Hospital,Udaipur.  
Address  Dept of Anaesthesiology,RNT medical college,Udaipur,Rajasthan,India,313001.

Udaipur
RAJASTHAN
313001
India 
Phone  9829623028  
Fax    
Email  devendraanaes@yahoo.in   
 
Details of Contact Person
Scientific Query  
Name  Dr Devendra Verma 
Designation  Senior Professor 
Affiliation  RNT Medical College & MB Hospital,Udaipur.  
Address  Dept of Anaesthesiology,RNT medical college,Udaipur,Rajasthan,India,313001.


RAJASTHAN
313001
India 
Phone  9829623028  
Fax    
Email  devendraanaes@yahoo.in   
 
Details of Contact Person
Public Query  
Name  Dr Shivaleela Muthyala 
Designation  PG Resident 
Affiliation  RNT Medical College& MB Hospital,Udaipur. 
Address  Dept of Anaesthesiology,RNT Medical College,Udaipur,Rajasthan,India,313001.

Udaipur
RAJASTHAN
313001
India 
Phone  9908030934  
Fax    
Email  leela6123@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesiology,RNT Medical College,Udaipur,Rajasthan,313001. 
 
Primary Sponsor  
Name  RNT Medical College 
Address  Dept of Anaesthesiology,RNT Medical College,Udaipur,Rajasthan,313001 
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 Shivaleela Muthyala  RNT medical college  CLR operation theatre,2nd floor Pannadhay Zanana building,Udaipur,Rajasthan
Udaipur
RAJASTHAN 		 9908030934

leela6123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC RNT MEDICAL COLLEGE RESEARCHER AND CONTROLLR UDAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80-O82||Encounter for delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ropivacaine  0.1% Ropivacaine for epidural labour analgesia for 1 year 
Intervention  Ropivacaine Vs Ropivacaine with Fentanyl  0.1% Ropivacaine with or without Fentanyl for epidural labour analgesia for 1 year 
Comparator Agent  Ropivacaine with fentanyl  0.1% Ropivacaine with fentanyl 2 mcg/ml for epidural labour analgesia for 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Age between 18 and 35 years
2. ASA grade I and II in active stage of labour (greater than or equal to 3 cm dilatation)
3. Primigravida
4. Singleton pregnancy
5. Vertex presentation
6. Uncomplicated pregnancy
7. Parturients requesting labour analgesia 
 
ExclusionCriteria 
Details  1. Patient refusal
2. ASA grade III and IV
3. Age greater than 35 years and less than 18 years
4. Multipara patients(greater than 2 children)
5. Comorbid conditions like Severe cardiac disease, Severe Pregnancy induced Hypertension, Eclampsia, Severe anemia, Psycological/Neurological disease
6. Complicated preganancies like Cephalo Pelvic disproportion, Breech presentation, Cord around neck and Previous Caesarean section.
7. Local sepsis
8. Altered coagulation profile
9. Bleeding disorders, thrombocytopenia
10. Spinal deformities
11. History of allergy to study drug 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the VAS score in both groups  0,5,15,30,45,60,90 minutes,every hourly maximum up to 8hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Time of onset of analgesia,Total dose of analgesia required,Total duration of labour,Neonatal outcome,Patient satisfaction score  0,5,15,30,45,60,90 min,every hourly maximum up to 8hrs, APGAR Score at 1 & 5 min. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   06/10/2025 
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="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   The goal of our present study is a comparative study of 0.1% Ropivacaine alone or with  Fentanyl (2 mcg/ml) for Epidural Labour Analgesia in randomized controlled double blind study with regard to VAS score ( pain intensity score), duration of different stages of labour, time of onset of analgesia,hemodynamic parameters,Neonatal assessment (APGAR Score), patient satisfaction score ,Complications related to drug/epidural catheter. 
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