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CTRI Number  CTRI/2024/09/074075 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 19/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the efficacy of two different drugs in peribulbar block in patients undergoing small incision cataract surgery. 
Scientific Title of Study   Efficacy of peribulbar block with the combination of 2 percent lidocaine and 0.75 percent ropivacaine versus 2 percent lidocaine and 0.5 percent bupivacaine in cataract surgery ; a randomised controlled trial. 
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 Prajakta Mehare 
Designation  Junior Resident 
Affiliation  NKP Salve institute of medical sciences  
Address  Atul Kirana Shop, Main Road, Borgaon Manju, Taluka District Akola

Akola
MAHARASHTRA
444102
India 
Phone  7499036449  
Fax    
Email  mehareprajakta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumita Bhargava 
Designation  Associate professor  
Affiliation  NKP Salve institute of medical sciences  
Address  Department of Anaesthesiology, fourth floor, NKP Salve institute of medical sciences and research centre and LMH hospital, Digdoh hills, Hingna road, Nagpur MAHARASHTRA 440019 India


MAHARASHTRA
440019
India 
Phone  7219105329  
Fax    
Email  bhargavasumita@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Prajakta Mehare 
Designation  junior resident 
Affiliation  NKP Salve institute of medical sciences  
Address  Department of Anaesthesiology, NKP Salve institute of medical sciences and research centre and LMH hospital, Digdoh hills, Hingna road, Nagpur MAHARASHTRA 440019 India

Nagpur
MAHARASHTRA
440019
India 
Phone  7499036449  
Fax    
Email  mehareprajakta@gmail.com  
 
Source of Monetary or Material Support  
NKP SALVE institute of medical sciences and Lata Mangeshkar hospital, Digdoh hills, Hingna road, Nagpur  
 
Primary Sponsor  
Name  NKP Salve institute of medical sciences and research centre and LMH hospital Nagpur  
Address  Digdoh hills, Hingna road, Nagpur, Maharashtra,India 440019  
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 Prajakta Mehare  Lata Mangeshkar hospital Nagpur   Department of Anaesthesiology, NKP Salve institute of medical sciences and research centre Digdoh hills, Hingna road, Nagpur Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 7499036449

mehareprajakta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NKP SALVE institute of medical sciences and RC nd Lata Mangeshkar Hospital , Nagpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H25||Age-related cataract, (2) ICD-10 Condition: H28||Cataract in diseases classified elsewhere, (3) ICD-10 Condition: H26||Other cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  lidocaine with bupivacaine and hyaluronidase  2% lidocaine 4ml with 0.5% bupivacaine 4ml and 15IU/ml of Hyaluronidase will be administered as an anaesthetic agent in the peribulbar block given to patients undergoing small incision cataract surgery. 
Intervention  lidocaine with ropivacine and Hyaluronidase  2 % lidocaine with 0.75% ropivacine and 15 IU/ml of Hyaluronidase will be administered as an anaesthetic agent in the peribulbar block given to patients undergoing small incision cataract surgery.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1} patients of ASA 1 and 2
2} patients posted for small incision cataract surgery 
 
ExclusionCriteria 
Details  1} patients having local sepsis, glaucoma, coagulation abnormality.
2} patient refusal
3} uncooperative patient 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare efficacy of combination of 2% lidocaine with 0.75% ropivacaine and 2% lidocaine with 0.5% bupivacaine for peribulbar block in patients undergoing cataract surgery with respect to :
1} onset of sensory blockade {in minutes}
2}onset of motor blockade {in minutes}
3} duration of post operative analgesia {in minutes} 		 1)Post operative pain assessment will be done every half hour for 2 hours and hourly for 6 hours.
2)24 hrs analgesic requirement will be noted 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the combination of 2% lidocaine with 0.75% ropivacaine & 2% lidocaine with 0.5% bupivacaine in patients undergoing cataract surgery under peribulbar block with respect to :
1} hemodynamic stability
2} side effects- nausea, vomiting 		 1} hemodynamic stability - systolic blood pressure
diastolic blood pressure
mean arterial blood pressure
heart rate
oxygen saturation
electrocardiogram
will be observed from the application of peribulbar block till the end of procedure.

2}side effects- nausea, vomiting will be observed from the application of peribulbar block till the end of procedure.
Time of block will be taken as 0 min & patient will be observered at 5 min intervals till end of procedure. 
 
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   Phase 3 
Date of First Enrollment (India)   30/09/2024 
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="2"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This study is a randomised, double blind  study to compare the effectiveness of two different drug combinations - 2% lidocaine with 0.75% ropivacaine and 2% lidocaine with 0.5% bupivacaine - in terms of duration of sensory blockade, motor blockade and post operative analgesia  in patients undergoing small incision cataract surgery. Either of the drug  combinatons depending on the study group, will be used as an anaesthetic agent of induction for peribulbar block in a total of 80 patients, divided into groups of 40 each and suffering from various types of cataract. This study will be conducted in the department of Anaesthesia at a tertiary care centre in Nagpur. 
The hemodynamic stability in terms of heart rate, systolic ,diastolic and mean arterial blood pressure , oxygen saturation along with side effects like nausea and vomitiing will be monitored from the time of application of the block till the end of procedure.
 
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