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CTRI Number  CTRI/2024/08/072068 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 03/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing the safety and effectiveness of two anesthetic mixtures for cataract surgery. 
Scientific Title of Study   A Comparative Study of Safety and Efficacy between 0.75% Ropivacaine and 1:1 Mixture of 2% Lidocaine with 0.5% Bupivacaine in Peribulbar Blocks for Cataract Surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K JAI PAVAN SIDDHARTH 
Designation  JUNIOR RESIDENT 
Affiliation  SRI DEVARAJA URS MEDICAL COLLEGE 
Address  OPD No 22, R L JALAPPA HOSPITAL KOLAR KARNATAKA
DEPT OF OPHTHALMOLOGY, SRI DEVARAJ URS MEDICAL COLLEGE ,KOLAR KARNATAKA
Kolar
KARNATAKA
563101
India 
Phone  8500592021  
Fax    
Email  kjpsiddharth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Manjula. T R 
Designation  Professor 
Affiliation  SRI DEVARAJA URS MEDICAL COLLEGE 
Address  OPD NO 22, R L JALAPPA HOSPITAL KOLAR KARNATAKA
DEPT OF OPHTHALMOLOGY, SRI DEVARAJ URS MEDICAL COLLEGE ,KOLAR KARNATAKA
Kolar
KARNATAKA
563101
India 
Phone  9886591772  
Fax    
Email  drmanjulamims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  K JAI PAVAN SIDDHARTH 
Designation  JUNIOR RESIDENT 
Affiliation  SRI DEVARAJA URS MEDICAL COLLEGE 
Address  OPD NO 22, R L JALAPPA HOSPITAL KOLAR KARNATAKA
DEPT OF OPHTHALMOLOGY, SRI DEVARAJ URS MEDICAL COLLEGE ,KOLAR KARNATAKA

KARNATAKA
563101
India 
Phone  8500592021  
Fax    
Email  kjpsiddharth@gmail.com  
 
Source of Monetary or Material Support  
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
 
Primary Sponsor  
Name  Dr Jai Pavan Siddharth 
Address  OPD NO 22 R L JALAPPA HOSPITAL KOLAR KARNATAKA Dept of Ophthalmology SRI DEVARAJ URS MEDICAL COLLEGE KOLAR KARNATAKA 
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 K Jai Pavan Siddharth  R L JALLAPPA HOSPITAL  NO 22, DEPARTMENT OF OPHTHALMOLOGY, SRI DEVARAJ URS MEDICAL COLLEGE, KOLAR KARNATAKA
Kolar
KARNATAKA 
8500592021

kjpsiddharth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI DEVARAJ URS CENTRAL ETHICS COMMITTTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with both genders of age between (40 to 75) who are diagnosed with cataract and are eligible for cataract surgery. 
 
ExclusionCriteria 
Details  1. Patients with previous history of ophthalmic surgery such as buckling surgery.
2. Patients with allergy to the Drug
3. Patients who are unwilling for the regional block.
4. Pre-existing ocular muscle paresis, neurological deficit.
5. Co-existing inflammatory conditions of eye.
6. History of trauma to the eye
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the time of onset & duration of anesthesia, Akinesia & Analgesia after peribulbar anesthesia in cataract surgery  after 5 and 10- and 15-minutes administration of local anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
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   N/A 
Date of First Enrollment (India)   15/08/2024 
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 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  

Anesthesia for ophthalmic surgery requires a careful approach. Majority of the patients presenting belong to the geriatric age group. Surgery in this population group is always challenging and is associated with various risks, whether it is performed under general anesthesia or regional anesthesia.

As general anesthesia can be hazardous in the elderly population and not advisable in view of a short procedure (15–20 min), needle blocks especially peribulbar blocks are the most preferred for anesthesia in cataract surgeries.

Peribulbar anesthesia is routinely performed with a mixture of local anesthetics, most commonly bupivacaine and lidocaine. Although Bupivacaine is commonly used due to its longer duration of action, it became apparent that accidental overdose was often fatal due to severe cardiac arrhythmias and neurotoxic effects.1

The aminoamide, Ropivacaine, a derivative of mepivacaine, was introduced in 1996 as the safer alternative to bupivacaine. It has a significantly higher threshold for cardiac and CNS toxicity than bupivacaine due to its less lipophilic and stereoselective properties.2

Hence we intend to take up this study in out set up to compare the safety and efficacy between 0.75% Ropivacaine and 1:1 mixture of 2% Lidocaine and 0.5% Bupivacaine in peribulbar blocks in patients undergoing cataract surgery.


Another comparative study on 80 patients showed that Ropivacaine 0.5% and lidocaine 2% as a 1:1 mixture in a volume of 8 ml with 100 IU of hyaluronidase was as effective as a 1:1 mixture of bupivacaine 0.5% and lidocaine 2% in a volume of 8 ml with 100 IU of hyaluronidase with regards to onset and total duration of the block and side effects and hemodynamic changes.1

A case control study compared 2 local anaesthetics (lignocaine + Bupivacaine with Ropivacaine) in patients undergoing cataract surgery and concluded that Ropivacine as a local anaesthetic drug has slightly higher efficacy and faster onset than that of traditional lignocaine with bupivacaine combination.3

Ropivacaine is found to be a suitable choice for local anesthesia showing a short and predictable onset of surgical anesthesia with better control of post-operative pain relief. 4

A study comparing Ropivacaine & mixture of bupivacaine/lignocaine revealed that ropivacaine represents an effective alternative to mixture of bupivacaine/lignocaine in peribulbar anaesthesia, due to the similar characteristics in motor and sensitive blockade, intraocular dynamics and its lower systemic toxicity. Therefore, 0.75% ropivacaine alone is a suitable option for performing peribulbar block in cataract surgery.5

 In ophthalmic surgeries, ropivacaine in peribulbar anesthesia is associated with lower rate of block failure when compared to bupivacaine.6



 
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