| CTRI Number |
CTRI/2024/04/065475 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A compare effectiveness of two modes of anaesthesia in cataract surgery: topical anaesthesia and peribulbar anaesthesia |
|
Scientific Title of Study
|
A comparative study to evaluate effectiveness of topical anaesthesia with peribulbar anaesthesia in patients undergoing manual small incision cataract surgery at tertiary care center Rajnandgaon,chhatisgarh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUNANDA KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Bharat ratna late shri atal bihari vajpayee memorial medical college, rajnandgaon |
| Address |
Department of ophthalmology,
,Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, pendri , Rajnandgaon, chhatisgarh
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8873159746 |
| Fax |
|
| Email |
sunanda1364@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SOMYA DULANI |
| Designation |
HOD |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Department of ophthalmology,
,Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, pendri , Rajnandgaon, chhatisgarh
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9479040709 |
| Fax |
|
| Email |
drsomya1010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUNANDA KUMARI |
| Designation |
PG RESIDENT |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Department of ophthalmology,
,Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, pendri , Rajnandgaon, chhatisgarh
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8873159746 |
| Fax |
|
| Email |
sunanda1364@gmail.com |
|
|
Source of Monetary or Material Support
|
| bharat ratna late shri atal bihari vajpayee memorial medical college,pendri, rajnandgaon, Chhattisgarh,India 491441 |
|
|
Primary Sponsor
|
| Name |
SUNANDA KUMARI |
| Address |
Department of ophthalmology, room no. 115, 1st floor, bharat ratna late shri atal bihari vajpayee memorial medical college, rajnandgaon |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SUNANDA KUMARI |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College and Hospital |
department of ophthalmology, 1st floor, room no. 115, bharat ratna late shri atal bihari vajpayee memorial medical college
Rajnandgaon
CHHATTISGARH |
8873159746
sunanda1364@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BRLSABVM MEDICAL COLLEGE RAJNANDGAON |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
anaesthesia in cataract surgery |
All the patients posted for cataract surgery divided randomly into group A as topical anaesthesia and group B as peribulbar group. The patient and operating surgeon will be given a questionnair to evaluate their experience in terms of pai surgical complication. The surgeon evaluation was based on four parameter, patients cooperation, difficulty due to ocular movements, anterior chamber stability, complicatons adverse events.The patients evaluation based on pain experienced during and after procedure. |
| Comparator Agent |
lignoaine combination with bupivacaine |
peribulbar block- 5-7 ml mixture of 2% xylocain and 0.5% bupivacain given in peribulbar space.
intraoprative and post operative evaluation will be done.
|
| Comparator Agent |
proparacain |
topical anaesthesia-drug used proparacain5%
15 minute before surgery 3 times.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.The patient with significant senile cataract causing impairment of visual functions.
2.Patients who can follow verbal commands
3.Those patients willing to participate and give consent for study
|
|
| ExclusionCriteria |
| Details |
1.Patients with complicated cataract and associated other ocular disease
2.Patients allergic to xylocaine
3.Patients with complex anterior segment pathologies
4.Patients with excessive anxiety
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| topical anaesthesia less invasive than peribulbar anaesthesia |
within 24 hours of cataract surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Block related comolications can be more in peribulbar group than topical group |
within 24 hours of catract surgery |
| advantages and disadvantages of two modes of anaesthesia |
anaesthesia related complications |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
I want to conduct "A Comparative Study of topical anaesthesia with peribulbar anaesthesia in patients undergoing manual small incision Cataract surgery for my MS ophthalmology Thesis. AIM: To compare the effectiveness of topical with peribulbar anaesthesia in patients undergoing manual small incision cataract surgery at tertiary care. OBJECTIVES : Efficacy and safety of anaesthesia in cataract surgery SETTING : Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon , Chhattisgarh STUDY DESIGN : Prospective randomized Interventional study TIME FRAME : April 2024 – july 2024 POPULATION/PARTICIPANTS : Patients undergoing for cataract surgery at B.R.L.S.A.B.V.M. Medical College , Rajnandgaon from April 2024 – July 2024. SAMPLE SIZE : The sample size of the study is taken as 150 with 75 samples in each group.
METHODS : Informed and written consent, pre-operative anaesthesia, intraoperative and post-operative evaluation OUTCOME MEASURES : Effectiveness during surgery Advantages and Disadantages of both modes of anaesthesia. STATISTICAL ANALYSIS: Statistical analysis will be performed by the Statistical Package for ServiceSolutions (SPSS) program for Windows, version 20.0.Continuous variableswill be presented as mean ± SD, and categorical variables will be presented as absolute numbers and percentage .Data will be checked for normality before statistical analysis. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that will not be normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test.
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