| CTRI Number |
CTRI/2024/06/069104 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study and compare two drug combinations used in cataract surgery to reduce pain and sensation during surgery. |
|
Scientific Title of Study
|
COMPARISON OF 0.5% ROPIVACAINE- 2% LIDOCAINE COMBINATION VERSUS 0.5% BUPIVACAINE-2% LIDOCAINE COMBINATION FOR PERIBULBAR BLOCK ANAESTHESIA IN MANUAL SMALL INCISION CATARACT SURGERY- AN OBSERVATIONAL STUDY |
| 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 Sanjeev Kumar Yumnam |
| Designation |
Post-graduate (MS Ophthalmology) |
| Affiliation |
Department of Ophthalmology, Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Ophthalmology,
Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
6000252983 |
| Fax |
|
| Email |
sanjeevkryumnam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srikanth K |
| Designation |
Professor |
| Affiliation |
Department of ophthalmology, Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of ophthalmology,
Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
|
| Fax |
|
| Email |
srikanthk@mgmcri.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Kumar Yumnam |
| Designation |
Post-graduate (MS Ophthalmology) |
| Affiliation |
Department of ophthalmology, Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of ophthalmology,
Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
6000252983 |
| Fax |
|
| Email |
sanjeevkryumnam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry, India. PIN- 607402 |
|
|
Primary Sponsor
|
| Name |
Dr Sanjeev Kumar Yumnam |
| Address |
Department of ophthalmology,
Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry, India. PIN- 607402 |
| 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 Sanjeev Kumar Yumnam |
Mahatma Gandhi medical college and research institute |
Department of ophthalmology, first floor room no 118
Pondicherry
PONDICHERRY |
6000252983
sanjeevkryumnam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Dose: 2ml of 0.5% Bupivacaine and 3ml of 2% lidocaine combination (total 5ml)
Frequency: single dose
Route of administration: peribulbar injection into the extraconal space of the orbit
Duration of intervention: 1day |
| Intervention |
Ropivacaine |
Dose: 2ml of 0.5% Ropivacaine and 3ml of 2% lidocaine combination (total 5ml)
Frequency: single dose
Route of administration: peribulbar injection into the extraconal space of the orbit
Duration of intervention: 1day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria: All patients undergoing surgery above 18 years of age and without other co-morbidities. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Patients with allergy to local anesthetics
Post traumatic cataract
Myopic with axial length more than 26mm
Patients on anticoagulant therapy or with bleeding diathesis
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of anesthesia. |
24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine surgeon and patient satisfaction and amount of total analgesics required following surgery in the first 24 hours with 0.5%Ropivacaine-2%Lidocaine combination and 0.5%Bupivacaine-2%Lidocaine combination in peribulbar block anesthesia in manual small incision cataract surgery.
|
Intraoperative assessment.
For analgesics- within 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sanjeevkryumnam@gmail.com].
- For how long will this data be available start date provided 14-06-2024 and end date provided 14-06-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cataract surgery is one of the most commonly performed surgeries in
ophthalmology which is done under regional anesthesia. With the nature of
surgery being one that requires precision it is important to make sure that the
regional anesthesia administered should provide a good blockade and of adequate
duration for which Bupivacaine-Lidocaine combination has been the
quintessential drug combination for providing peribulbar block anesthesia for
cataract surgeries.
However Bupivacaine has been reported to have cardiovascular and
neurological side effects. It can inhibit
cardiac conductivity and contractility and may induce ventricular
fibrillations. Neurological adverse effect may include perioral numbness, CNS
depression, seizures and respiratory depression.
Ropivacaine, a relatively newer
drug on the other hand has a greater margin of safety with lesser
cardiovascular and neurological side effects. Studies have been conducted with
using 0.75% or 1% Ropivacaine without Lidocaine and not much studies have
compared equal concentrations of the two drugs.
With this in consideration this study is designed to compare 0.5%Ropivacaine-2%Lidocaine
combination with 0.5%Bupivacaine-2%Lidocaine combination for peribulbar block
in manual small incision cataract surgery.
|