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CTRI Number  CTRI/2024/11/076389 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 30/01/2026
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   A comparative study of efficacy of two drugs Ropivacaine and Bupivacaine ,both with same additive Fentanyl for perineal surgeries under spinal anesthesia  
Scientific Title of Study   Comparison Of Intrathecal Hyperbaric Bupivacaine with Fentanyl Versus Hyperbaric Ropivacaine with fentanyl for perineal surgeries under Subarachnoid block : A Randomised 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  DrGayathri K V 
Designation  Postgraduate Resident 
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology Bangalore Medical College and Research Institute, K R Road Fort Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  6361763099  
Fax    
Email  gayathrivijay.k@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dayananda V P 
Designation  Professor 
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology Bangalore Medical College and Research Institute K R Road Fort Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  919845161826  
Fax    
Email  Vpd921@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrDayananda V P  
Designation  Professor  
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology Bangalore Medical College and Research Institute K R road Fort Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  919845161826  
Fax    
Email  Vpd921@yahoo.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute Fort Krishna Rajendra Road Kalasipalaya Bengaluru Karnataka 560002 
 
Primary Sponsor  
Name  Bangalore Medical College and Research Institute  
Address  Bangalore Medical College and Research Institute K R Road Fort Bangalore 560002  
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 Gayathri K V  Bangalore Medical College and Research Institute   Department of Anaesthesiology Bangalore Medical College and Research Institute KR Road Fort Bangalore
Bangalore
KARNATAKA 
6361763099

gayathrivijay.k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N476||Balanoposthitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection Bupivacaine heavy 0.5% with Injection Fentanyl 25mcg intrathecally for perineal surgeries   Bupivacaine heavy 0.5% 2cc with Fentanyl 25mcg given intrathecally for subarachnoid block in patients undergoing perineal surgeries , administered once , duration 2 hours 30 minutes 
Intervention  Injection Ropivacaine Heavy 0.75% with Injection Fentanyl 25mcg intrathecally for perineal surgeries   Ropivacaine heavy 0.75% 2cc with Fentanyl 25mcg given intrathecally for subarachnoid block in patients undergoing perineal surgeries , frequency once , duration 2 hours 30 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Societ of Anaesthesiologists (ASA) Grade 1 and 2 patients undergoing perineal surgeries under subarachnoid block 
 
ExclusionCriteria 
Details  Patients refusing to participate in study
Patients with history of hypersensitivity to local anesthetics
Emergency cases and cases with ASA Grade 3 or above
Patients with sepsis in Lumbar region,Patients with pre-existing neurological disorders or spine deformity
Surgeries involving major blood loss 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time for sensory blockade at T10
Time for highest sensory blockade
Time for complete Motor blockade
Hemodynamic parameters 
Every one minute

Every one minute
 
 
Secondary Outcome  
Outcome  TimePoints 
Time for complete Motor regression
Time for complete sensory regression
Time for post operative voluntary micturition  
Every 2 hours until 6 hours
Every 2 hours until 6 hours 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   26/11/2024 
Date of Study Completion (India) 30/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/08/2025 
Estimated Duration of Trial   Years="0"
Months="8"
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   Subarachnoid block is commonly practiced worldwide as a standard of care for perineal, lower abdominal and lower limb surgeries. It has been proven that combination of adjuvants to local anaesthetic prolong duration of analgesia postoperatively.Ropivacaine has high pka, low lipid solubility[3].It is found to block sensory nerves to a greater degree than motor nerves .Ropivacaine and Bupivacaine have similar local anesthetic properties and chemical structure[1][4]. Ropivacaine is expected to be a suitable drug for day care surgeries because of less motor block with great sensory motor dissociation and could be associated with early post-operative mobilization.
                                 The concept of day-care or ambulatory surgery has been well established in developed countries though it is still in its infancy in developing countries such as India. There is an immense opportunity for expansion in day-care surgery in India with it’s huge population of 1.2 billion and expanding private sector .
                              In India, there is lack of studies with proper documentation regarding day-care anaesthesia . 11%–23% of the surgeries in India performed in hospital settings are considered to be on outpatient basis based on available data from unpublished source.
                           The study aims to compare relatively novel drug ropivacaine with bupivacaine in it’s effectiveness in terms of duration of anaesthesia , intraoperative quality of block and post operative recovery in perineal surgeries , a ususal form of ambulatory surgery. The identification of a suitable drug for ambulatory surgeries would help in popularizing the method of surgery and would cut down cost ,easy return to work , lack of dependency on availability of hospital beds, reduced nosocomial infection rates for patients.

 
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