| CTRI Number |
CTRI/2024/08/072068 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the safety and effectiveness of two anesthetic mixtures for cataract surgery. |
|
Scientific Title of Study
|
A Comparative Study of Safety and Efficacy between 0.75% Ropivacaine and 1:1 Mixture of 2% Lidocaine with 0.5% Bupivacaine in Peribulbar Blocks for Cataract Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K JAI PAVAN SIDDHARTH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRI DEVARAJA URS MEDICAL COLLEGE |
| Address |
OPD No 22, R L JALAPPA HOSPITAL KOLAR KARNATAKA DEPT OF OPHTHALMOLOGY, SRI DEVARAJ URS MEDICAL COLLEGE ,KOLAR KARNATAKA Kolar KARNATAKA 563101 India |
| Phone |
8500592021 |
| Fax |
|
| Email |
kjpsiddharth@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Manjula. T R |
| Designation |
Professor |
| Affiliation |
SRI DEVARAJA URS MEDICAL COLLEGE |
| Address |
OPD NO 22, R L JALAPPA HOSPITAL KOLAR KARNATAKA DEPT OF OPHTHALMOLOGY, SRI DEVARAJ URS MEDICAL COLLEGE ,KOLAR KARNATAKA Kolar KARNATAKA 563101 India |
| Phone |
9886591772 |
| Fax |
|
| Email |
drmanjulamims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
K JAI PAVAN SIDDHARTH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRI DEVARAJA URS MEDICAL COLLEGE |
| Address |
OPD NO 22, R L JALAPPA HOSPITAL KOLAR KARNATAKA DEPT OF OPHTHALMOLOGY, SRI DEVARAJ URS MEDICAL COLLEGE ,KOLAR KARNATAKA
KARNATAKA 563101 India |
| Phone |
8500592021 |
| Fax |
|
| Email |
kjpsiddharth@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
Dr Jai Pavan Siddharth |
| Address |
OPD NO 22 R L JALAPPA HOSPITAL KOLAR KARNATAKA
Dept of Ophthalmology
SRI DEVARAJ URS MEDICAL COLLEGE KOLAR KARNATAKA |
| 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 K Jai Pavan Siddharth |
R L JALLAPPA HOSPITAL |
NO 22, DEPARTMENT OF OPHTHALMOLOGY, SRI DEVARAJ URS MEDICAL COLLEGE, KOLAR KARNATAKA Kolar KARNATAKA |
8500592021
kjpsiddharth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DEVARAJ URS CENTRAL ETHICS COMMITTTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with both genders of age between (40 to 75) who are diagnosed with cataract and are eligible for cataract surgery. |
|
| ExclusionCriteria |
| Details |
1. Patients with previous history of ophthalmic surgery such as buckling surgery.
2. Patients with allergy to the Drug
3. Patients who are unwilling for the regional block.
4. Pre-existing ocular muscle paresis, neurological deficit.
5. Co-existing inflammatory conditions of eye.
6. History of trauma to the eye
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the time of onset & duration of anesthesia, Akinesia & Analgesia after peribulbar anesthesia in cataract surgery |
after 5 and 10- and 15-minutes administration of local anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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 Yet Recruiting |
| 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
|
Anesthesia for ophthalmic surgery requires a
careful approach. Majority of the patients presenting belong to the geriatric
age group. Surgery in this population group is always challenging and is
associated with various risks, whether it is performed under general anesthesia
or regional anesthesia.
As general anesthesia can be hazardous in the elderly population
and not advisable in view of a short procedure (15–20 min), needle blocks
especially peribulbar blocks are
the most preferred for anesthesia in cataract surgeries.
Peribulbar anesthesia is routinely performed with a
mixture of local anesthetics, most commonly bupivacaine and lidocaine. Although
Bupivacaine is commonly used due to its longer duration of action, it became
apparent that accidental overdose was often fatal due to severe cardiac
arrhythmias and neurotoxic effects.1
The aminoamide, Ropivacaine, a derivative of
mepivacaine, was introduced in 1996 as the safer alternative to bupivacaine.
It has a significantly higher threshold for cardiac and CNS toxicity than
bupivacaine due to its less lipophilic and stereoselective properties.2
Hence we intend to take up this study in out set up to compare
the safety and efficacy between 0.75%
Ropivacaine and 1:1 mixture of 2% Lidocaine and 0.5% Bupivacaine in peribulbar
blocks in patients undergoing cataract surgery.
Another comparative study on 80 patients showed that Ropivacaine
0.5% and lidocaine 2% as a 1:1 mixture in a volume of 8 ml with 100 IU of
hyaluronidase was as effective as a 1:1 mixture of bupivacaine 0.5% and
lidocaine 2% in a volume of 8 ml with 100 IU of hyaluronidase with regards to
onset and total duration of the block and side effects and hemodynamic changes.1 A case control study compared 2 local anaesthetics
(lignocaine + Bupivacaine with Ropivacaine) in patients undergoing cataract
surgery and concluded that Ropivacine as a local anaesthetic drug has slightly
higher efficacy and faster onset than that of traditional lignocaine with
bupivacaine combination.3 Ropivacaine is found to be a suitable choice for local anesthesia showing
a short and predictable onset of surgical anesthesia with better control of
post-operative pain relief. 4 A study comparing Ropivacaine & mixture of
bupivacaine/lignocaine revealed that ropivacaine represents an effective
alternative to mixture of bupivacaine/lignocaine in peribulbar anaesthesia, due
to the similar characteristics in motor and sensitive blockade, intraocular
dynamics and its lower systemic toxicity. Therefore, 0.75% ropivacaine alone is
a suitable option for performing peribulbar block in cataract surgery.5
In
ophthalmic surgeries, ropivacaine in peribulbar anesthesia is associated with
lower rate of block failure when compared to bupivacaine.6
|