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CTRI Number  CTRI/2025/11/097633 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 18/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare the effect of heavy Ropivacaine with fentanyl versus the effect of heavy bupivaicaine with fentanyl for spinal block in patients undergoing surgeries below the belly button. 
Scientific Title of Study   SAFETY AND EFFICACY OF HYPERBARIC ROPIVACINE WITH FENTANYL VS HYPERBARIC BUPIVACAINE WITH FENTANYL IN INFRAUMBILICAL SURGERIES : A PROSPECTIVE RANDOMIZED CLINICAL 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 Hiral Sanghvi 
Designation  Postgraduate 
Affiliation  Dr D Y Patil School Of Medicine 
Address  A Block , Department of Anesthesia , D Y Patil School Of Medicine , Ayyappa Temple Road , Dr D Y Patil Vidyanagar ,Sector 5,Nerul Navi Mumbai , Thane Maharashtra - 400706

Thane
MAHARASHTRA
400706
India 
Phone  8779642589  
Fax    
Email  hiralsanghvi93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunanda Panigrahi 
Designation  Professor 
Affiliation  Dr D Y Patil School Of Medicine 
Address  A Block , Department of Anesthesia , D Y Patil School Of Medicine , Ayyappa Temple Road , Dr D Y Patil Vidyanagar ,Sector 5,Nerul Navi Mumbai , Thane Maharashtra - 400706

Thane
MAHARASHTRA
400706
India 
Phone  9820637093  
Fax    
Email  drnmishra1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunanda Panigrahi 
Designation  Professor 
Affiliation  Dr D Y Patil School Of Medicine 
Address  A Block , Department of Anesthesia , D Y Patil School Of Medicine , Ayyappa Temple Road , Dr D Y Patil Vidyanagar ,Sector 5,Nerul Navi Mumbai , Thane Maharashtra - 400706


MAHARASHTRA
400706
India 
Phone  9820637093  
Fax    
Email  drnmishra1@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr D Y Patil School Of Medicine 
Address  A Block , Department of Anesthesia , D Y Patil School Of Medicine , Ayyappa Temple Road , Dr D Y Patil Vidyanagar ,Sector 5,Nerul Navi Mumbai , Thane Maharashtra - 400706 
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 Hiral Sanghvi  Dr D Y Patil School Of Medicine  A Block , Department of Anesthesia , D Y Patil School Of Medicine , Ayyappa Temple Road , Dr D Y Patil Vidyanagar ,Sector 5,Nerul Navi Mumbai , Thane Maharashtra - 400706
Thane
MAHARASHTRA 		 8779642589

hiralsanghvi93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee for Biomedical and Health Research (IECBH) of Dr D Y Patil Medical College & Hospital, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hyperbaric Bupivacaine 0.5% 15mg with Fentanyl Citrate 20mcg  Route : Intrathecal Dose : 15mg Bupivacaine + 20mcg Fentanyl Duration : over 10 seconds 
Intervention  Hyperbaric Ropivacaine 0.75% 22.5mg with Fentanyl Citrate 20 mcg  Route : Intrathecal Dose : 22.5mg Ropivacaine + 20mcg Fentanyl Duration : over 10 seconds 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age of 18 to 65 years

ASA Grade I and II

Patients undergoing various infra-umbilical surgeries under spinal anaesthesia 
 
ExclusionCriteria 
Details  Refusal of spinal anaesthesia

Coagulopathies

Head injury and raised ICP

Psychiatric diseases

Known allergy to test drug

Infection at site of injection

Uncorrected Hypovolemia

Fixed cardiac output states

Pregnant patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Ropivacaine with fentanyl and bupivacaine with fentanyl based on onset and duration of motor blockage
 		 base-line , before administration of spinal drug , 2min ,4mins,6 mins,8mins,10min,12mins,14mins,16mins,20mins ,30mins,then hourly till end of surgery , post op upto 4 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare and assess in the two groups:
1) Onset and duration of sensory blockage
2) Hemodynamic stability
3) Adverse effects if any 		 base-line , before administration of spinal drug , 2min ,4mins,6 mins,8mins,10min,12mins,14mins,16mins,20mins ,30mins,then hourly till end of surgery , post op upto 4 hours 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   08/12/2025 
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="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 a widely used and highly effective technique in modern anaesthesia, offering numerous advantages over general anaesthesia, such as reduced stress response, superior post-operative pain relief, and faster recovery times. These benefits make it particularly suitable for lower abdominal and lower limb surgeries.Bupivacaine, an amide local anaesthetic, has become the mainstay for spinal anaesthesia, owing to its potent and long-lasting effects. While it provides excellent sensory and motor block, bupivacaine’s prolonged motor block can delay recovery, making it less ideal for ambulatory surgeries where rapid motor function recovery is essential.Ropivacaine, a newer amide local anaesthetic, has emerged as a promising alternative. It shares many properties with bupivacaine but has a more favourable safety profile. Ropivacaine is less cardiotoxic and produces less motor block, allowing for quicker recovery of motor function, which makes it a suitable choice for day-care and ambulatory procedures.The addition of intrathecal opioids, such as fentanyl, to local anaesthetics has been shown to enhance the quality of spinal anaesthesia by intensifying the sensory block without increasing sympathetic block. This synergy allows for the use of lower doses of local anaesthetic, which further reduces the risk of side effects and facilitates earlier recovery.
Aim of the study is to Compare the efficacy of hyperbaric Ropivacaine plus Fentanyl vs hyperbaric Bupivacaine with Fentanyl.In this prospective clinical study, after approval from Institutional Ethical Committee and obtaining informed written consent, 128 patients of American Society of Anaesthesiologists (ASA) class I or class II of either sex, aged 18 - 65 years undergoing elective infraumbilical surgeries will be recruited. A thorough prospective clinical assessment done pre operatively.
Patients will be randomly allocated into two groups each containing 64 patients by computer generated random numbers.

Group L (n=64) will receive spinal anesthesia with 3ml of 0.5% hyperbaric bupivacaine with 20mcg of Fentanyl.

Group R (n=64) will receive spinal anesthesia with 3ml of 0.75% hyperbaric Ropivacaine with 20mcg of Fentanyl
After ensuring sterile conditions, spinal anaesthesia will be performed, and the patient will receive one of the two study drugs in sitting position, using 25G Quincke’s needle inserted at L3-L4 interspace. Drug will be injected and patient will be asked to lie down.
o The sensory block level evaluation – Pin Prick Method
o The motor block level evaluation – Modified Bromage Scale.

During the tracking of the sensory block in patients maximum sensory block level, time to achieve maximum sensory block, and it’s regression to L1 dermatome will be recorded.
Patients will be observed for any discomfort, nausea, vomiting, shivering, pruritus, bradycardia and any other side effects and the need for additional medications will be recorded.

 
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