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CTRI Number  CTRI/2026/03/106741 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 22/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized Factorial Trial 
Public Title of Study   COMPARATIVE ANALYSIS OF ANAESTHETIC DRUGS HYPERBARIC ROPIVACAINE AND HYPERBARIC BUPIVACAINE SAFETY IN PATIENTS UNDERGOING INFRA-UMBILICAL SURGERIES 
Scientific Title of Study   COMPARATIVE ANALYSIS OF ANAESTHETIC CHARACTERSTICS AND SAFETY OF INTRATHECAL 0.75% HYPERBARIC ROPIVACAINE AND 0.5% HYPERBARIC BUPIVACAINE IN PATIENTS UNDERGOING INFRA-UMBILICAL SURGERIES - A RANDOMIZED DOUBLE - BLIND 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 MOHAMMED YUNUS KHILJI 
Designation  PROFESSOR 
Affiliation  Sardar Patel Medical College Bikaner Rajasthan India 
Address  Department of Anaesthesia
Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India 
Phone  8587858715  
Fax    
Email  mohammedyunus.khilji@nhs.net  
 
Details of Contact Person
Scientific Query
 
Name  DR RANU 
Designation  PG RESIDENT 
Affiliation  Sardar Patel Medical College Bikaner Rajasthan India 
Address  Department of Anaesthesia
Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India 
Phone  8587858715  
Fax    
Email  drranu1109@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR MOHAMMED YUNUS KHILJI 
Designation  PROFESSOR 
Affiliation  Sardar Patel Medical College Bikaner Rajasthan India 
Address  Department of Anaesthesia
Sardar Patel Medical College

RAJASTHAN
334001
India 
Phone  8587858715  
Fax    
Email  mohammedyunus.khilji@nhs.net  
 
Source of Monetary or Material Support  
DEPT. OF ANAESTHESIA , SARDAR PATEL MEDICAL COLLEGE, BIKANER, RAJASTHAN 
 
Primary Sponsor  
Name  Sardar Patel Medical College Bikaner 
Address  DEPT. OF ANAESTHESIA , SARDAR PATEL MEDICAL COLLEGE, BIKANER, RAJASTHAN 
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 MOHAMMED YUNUS KHILJI  Sardar Patel Medical College Bikaner  Department of Anaesthesia Sardar Patel Medical College Bikaner Rajasthan India
Bikaner
RAJASTHAN 
8587858715

mohammedyunus.khilji@nhs.net 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE , SPMC BIKANER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (2) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (3) ICD-10 Condition: M220||Recurrent dislocation of patella,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% hyperbaric bupivacaine  intrathecal 
Intervention  0.75% hyperbaric ropivacaine   intrathecal 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 and 2
BMI 18.5 TO 30 KG/M2
ELECTIVE INFRA UMBILICAL SUREGRY UNDER SPINAL ANAESTHESIA 
 
ExclusionCriteria 
Details  KNOWN HYPERSENSITIVITY TO AMIDE TYPE LOCAL ANAESTHETICS
ASA 3and ABOVE
BLEEDING DISORDERS
LOCAL INFECTION 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
TO DETERMINE THE CHARACTERISTICS(ONSET AND DURATION) OF SENSORY BLOCK BETWEEN TWO GROUP   Time to T10, 2min, 4min, 6min,8min, 10min.

peak sensory level
max bromage score 
 
Secondary Outcome  
Outcome  TimePoints 
TO DETERMINE THE ONSET AND DURATION OF MOTOR BLOCK,
TO DETERMINE QUALITY OF PERIOPERATIVE ANALGESIA 
FROM SPINAL ANAESTHESIA TO UPTO 10 MIN 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   06/04/2026 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Regional anaesthesia plays a pivotal role in providing effective pain relief and facilitating early recovery in patients undergoing infra-umbilical surgeries.

Spinal Anaesthesia (Intrathecal Anaesthesia) is a widely employed form of central neuraxial blockade.It involves the injection of a local anaesthetic into the cerebrospinal fluid (CSF) present in the subarachnoid space, typically between the L3-L4 or L4-L5 intervertebral space. This leads to reversible blockade of nerve conduction, resulting in loss of sensation and muscle relaxation below the level of the block.

Spinal anaesthesia is often favoured over general anaesthesia for surgical procedures involving the lower abdomen and lower limbs, owing to its numerous advantages such as the simplicity of equipment, cost-effectiveness, provision of profound analgesia, satisfactory muscle relaxation, reduced intra operative blood loss and minimal metabolic disturbances.

Ropivacaine and Bupivacaine are two long-acting local anaesthetics widely used in spinal anaesthesia. Both agents are effective for producing adequate sensory and motor block.

Bupivcaine, introduced in 1956, is an amino acid local anaesthetic comprising a racemic mixture of S- and R-enantiomers. It has become a preferred agent for spinal anaesthesia due to its ability to achieve effective sensory and motor blockade.

Bupivacaine has been associated with several side effects including motor weakness, urinary retention and toxicity affecting the cardiovascular and central nervous system.

Ropivacaine is a newer long-acting amide local anaesthetic and the monohydrate of the hydrochloride salt of 1-propyl-2’,6’-pipecoloxylidide. It is the first clinically used pure      S(-) enantiomeric local anaesthetic.  It came into market in 1996. This contributes to its lower risk of cardiovascular and central nervous system toxicity as compared to bupivacaine.

Although numerous studies have evaluated the use of ropivacaine for local infiltration, epidural and peripheral nerve blocks. Clinical data regarding its characteristics following intrathecal administration remain limited.

 
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