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CTRI Number  CTRI/2016/11/007445 [Registered on: 08/11/2016] Trial Registered Retrospectively
Last Modified On: 28/12/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Ropivacaine and Bupivacaine in deep topical Anaesthesia in Patients Undergoing cataract surgery. 
Scientific Title of Study   Comparison between Ropivacaine and Bupivacaine in Deep topical fornix nerve block anaesthesia in patients undergoing cataract surgery by phacoemulsification 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Varshney 
Designation  Post Graduate 
Affiliation  Government Medical College, Haldwani 
Address  Government Medical College, Rampur Road, Haldwani-Nainital

Nainital
UTTARANCHAL
263139
India 
Phone  7060012005  
Fax    
Email  drrahulvarshney@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G S Titiyal  
Designation  Professor, 
Affiliation   
Address  Department of Ophthalmology, Government Medical College, Rampur Road, Haldwani-Nainital

Nainital
UTTARANCHAL
263139
India 
Phone  7060012005  
Fax    
Email  gstitiyal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Rahul Varshney 
Designation  Post Graduate 
Affiliation  Government Medical College, Haldwani 
Address  Government Medical College, Rampur Road, Haldwani-Nainital


UTTARANCHAL
263139
India 
Phone  7060012005  
Fax    
Email  drrahulvarshney@gmail.com  
 
Source of Monetary or Material Support  
Dr Sushila Tiwari Hospital and Government Medical College, Rampur Road, Haldwani-Nainital Uttarakhand 263139 
 
Primary Sponsor  
Name  Dr Sushila Tiwari Memorial Hospital 
Address  Department of Ophthalmology, Rampur Road, Haldwani, Haldwani-Nainital Uttarakhand 263139 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sushila Tiwari Memorial Hospital  Department of Anaesthesia, Rampur Raod, Haldwani, Haldwani-Nainital Uttarakhand 263139 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahul Varshney  Dr. Sushila Tiwari Memorial Hospital  Department of Ophthalmology, Government medical college, Haldwani-Nainital,
Nainital
UTTARANCHAL 		 7060012005

drrahulvarshney@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Deep Topical Fornix Nerve block anaesthesia (DTFNB)   DTFNB would be performed using two sponges (2x3mm) soaked with either 0.5% bupivacaine or 0.75% Ropivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with Paracaine local anaesthetic drops. The sponges are to be removed after 15 minutes. 
Comparator Agent  Group B  Deep Topical Fornix Nerve block anaesthesia DTFNB would be performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with Paracaine local anaesthetic drops. The sponges are to be removed after 15 minutes. 
Comparator Agent  Group R  Deep Topical Fornix Nerve block anaesthesia DTFNB would be performed using two sponges (2x3mm) soaked with 0.75% Ropivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with Paracaine local anaesthetic drops. The sponges are to be removed after 15 minutes. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  ASA grade I and II 
 
ExclusionCriteria 
Details  Younger than 50 years,
had any psychiatric illness (including significant anxiety),
nystagmus,
insufficient pupil dilatation,
very hard cataracts (NS 4-5),
allergy to local anaesthetics,
inability to understand language, or
if the patient refuses the topical anaesthesia technique. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Measure level of pain and discomfort during surgery   various Predefined stages of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Supplemental anaesthesia
 		 various stages of surgery 
Level of surgeon satisfaction  0: Poor,
1. Adequate,
2. Good 
Surgical complications  Various stages of surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract surgeries by phacoemulsification. This deep-topical, nerve-block technique produces a level of anaesthesia previously seen only with injection techniques. In this study we intend to compare Ropivacaine and Bupivacaine in various parameters during phacoemulsification. 
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