| CTRI Number |
CTRI/2024/08/071980 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of Ropivacaine and Bupivacaine for peribulbar anaesthesia in cataract surgery |
|
Scientific Title of Study
|
A Comparative study on efficacy of combination of 0.5 percentage Ropivacaine and 2 percentage lidocaine versus combination of 0.5 percentage Bupivacaine and 2 percentage lidocaine for peribulbar anaesthesia in cataract surgery |
| 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 Rohini Kanagarajan |
| Designation |
Postgraduate student, Department of Ophthalmology |
| Affiliation |
ESIC Medical College and Hospital, Hyderabad |
| Address |
Department of ophthalmology, ESIC medical college, Sanath Nagar, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8056522023 |
| Fax |
|
| Email |
rohinikanagarajan96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soujanya PSS |
| Designation |
Associate Professor, Department of Ophthalmology |
| Affiliation |
ESIC Medical College and Hospital, Hyderabad |
| Address |
Department of ophthalmology, ESIC medical college, Sanath Nagar, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
7396228294 |
| Fax |
|
| Email |
drsoujanyapss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soujanya PSS |
| Designation |
Associate Professor, Department of Ophthalmology |
| Affiliation |
ESIC Medical College and Hospital, Hyderabad |
| Address |
Department of Ophthalmology, ESIC medical college, Sanath Nagar, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
7396228294 |
| Fax |
|
| Email |
drsoujanyapss@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, ESIC Medical College and Hospital, Sanath nagar, Hyderabad. |
|
|
Primary Sponsor
|
| Name |
Dr Rohini Kanagarajan |
| Address |
Department of Ophthalmology, ESIC Medical College and Hospital, Sanath nagar, Hyderabad-500038 |
| 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 |
| Dr Rohini kanagarajan |
ESIC MEDICAL COLLEGE AND HOSPITAL |
Department of Ophthalmology, ESIC medical college and Hospital, sanath nagar, Hyderabad-500038
Hyderabad
TELANGANA |
8056522023
rohinikanagarajan96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College and Hospital and ESIC Super Speciality Hospital |
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 |
| Comparator Agent |
Bupivacaine |
The group B will be given a mixture of 4ml Bupivacaine and
4ml of 2% lidocaine and 100 IU of hyaluronidase for peribulbar anaesthesia in cataract surgery |
| Intervention |
Ropivacaine |
The group R will be given a mixture of 4ml of 0.5% Ropivacaine and 4ml of 2% Lidocaine and 100 IU of
hyaluronidase for peribulbar anesthesia in cataract surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age more than 18 planned for elective cataract surgery and IOL implantation at ESIC with ASA 1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
Any preceeding ocular diseases other than cataract, orbital anomalies, patients with known severe impairment of coagulation, severe systemic diseases and Axial length of eyeball more than 26mm |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of block , onset and total duration of sensory and motor blockade |
10 minutes, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse effects and complications associated with the medication during surgery and first 24 hours postoperative period, surgeon and patient satisfaction with analgesia and technique |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 is a prospective, randomized, double blinded study to compare the effectiveness of block characteristics and side effect profile of a mixture of 0.5% Ropivacaine and 2% Lidocaine with a mixture of 0.5% Bupivacaine and 2% Lidocaine for peribulbar block in cataract surgery. The primary objective of the study is to evaluate the peribulbar block efficacy by assessing the onset of block and total duration of sensory and motor block. The secondary objective is to assess the adverse reactions and immediate systemic complications associated with the medication, to know the patient and surgeon satisfaction with the analgesia and anaesthetic technique. By doing this study, if we establish that efficacy of Ropivacaine is on par with Bupivacaine with better side effect profile, we can implement regular usage of Ropivacaine for peribulbar anesthesia in cataract. Many patients posted for cataract surgery are elderly people with multiple systemic diseases. Through this study, if this novel anesthetic medication, Ropivacaine is proved to have better efficacy and safety profile, it can replace the usage of the traditional anesthetic medication which is associated with cardiovascular and neurological adverse effects.
|