| CTRI Number |
CTRI/2024/03/064131 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of 0.5% ropivacaine with combination of 0.5% bupivacaine and 2% lidocaine on intraocular pressure before and after peribulbar block in cataract surgery |
|
Scientific Title of Study
|
A comparative study of efficacy and safety of single drug 0.5% Ropivacaine on intraocular pressure before and after peribulbar block in cataract surgery with most commonly used mixture of 0.5% bupivacaine and 2% lidocaine with adrenaline : A randomised clinical 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 Rekha R Mudhol |
| Designation |
Professor and hod department of ophthalmology |
| Affiliation |
BLDE(DU)Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Room number-1, Department of Ophthalmology, BLDE(DU)Shri B M Patil Medical College Hospital and Research Centre, BANGARAMMA SAJJAN Campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9449938997 |
| Fax |
|
| Email |
rekhamudhol@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha |
| Designation |
2nd year PG, department of ophthalmology |
| Affiliation |
SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Room number-13, Department of Ophthalmology, BLDE(DU)Shri B M Patil Medical College Hospital and Research Centre, BANGARAMMA SAJJAN Campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9490941909 |
| Fax |
|
| Email |
snehachowdary972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha R Mudhol |
| Designation |
Professor and hod department of ophthalmology |
| Affiliation |
SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Room number-13, Department of Ophthalmology, BLDE(DU)Shri B.M. Patil Medical College Hospital and Research Centre, BANGARAMMA SAJJAN Campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9449938997 |
| Fax |
|
| Email |
rekhamudhol@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE(DU)Shri B.M. Patil Medical College Hospital and Research Centre, Vijayapura |
|
|
Primary Sponsor
|
| Name |
BLDE |
| Address |
Shri B M Patil Medical College Hospital and Research Centre Bangaramma sajjan campus Vijayapura |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Rekha R Mudhol |
BLDE(DU) Shri B M Patil Medical College Hospital and Research Centre |
Room number -13, Department of Ophthalmology, BANGARAMMA SAJJAN campus, Vijayapura-586103
Bijapur
KARNATAKA |
9449938997
rekhamudhol@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE Deemed to be University Vijayapura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SENILE IMMATURE CATARCT |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection ropivacaine 0.5% |
In one group - 8ml injection ropivacaine 0.5% as local anesthesia in peribulbar block in cataract surgery |
| Comparator Agent |
Mixture of 0.5% bupivacaine and 2% lidocaine injections
|
In one group - mixture of 4ml injection bupivacaine 0.5% and 4ml injection lignocaine 2% as local anesthesia in peribulbar block in cataract surgery |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Uncomplicated cataract.
2)Normal intraocular pressure |
|
| ExclusionCriteria |
| Details |
1)Patients with cognitive impairment.
2)Patients allergic to hyaluronidase, lidocaine, ropivacaine and bupivacaine.
3)Any other surgeries combined with cataract.
4)Patients with hypertension and coronary artery disease in lignocaine group.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)The study will help us to study the adverse effects caused by raised intra ocular pressure post peribulbar block and reduce the side effects caused by prolonged motor blockade by using a low concentrated anesthetic.
2)This study will help us to know an ideal drug for peribulbar block with minimal complications.
|
31 cases in 6months and total 62 cases in 1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will help us to know an ideal drug for peribulbar block with minimal complications.
|
31 cases in 6months and total 62 cases in 1 year
|
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/03/2024 |
| Date of Study Completion (India) |
14/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
In process, Submitting BLDE JOURNAL OF HEALTH SCIENCES |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A comparative study of 0.5% ropivacaine injection with mixture of 0.5% bupivacaine and 2% lignocaine in peribulbar block in cataract surgery to check the efficacy and safety by recording the intraocular pressure before and after peribulbar block. This study helps prevent complications caused by high intraocular pressure and prolonged motor blockade in cataract surgery and also to know the ideal drug with minimal complications in cataract surgery. |