| CTRI Number |
CTRI/2024/04/065448 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two types of anaesthesia given before cataract surgery in terms of pain and eye movements |
|
Scientific Title of Study
|
A comparative study of Subtenons anaesthesia with peribulbar anaesthesia in manual small incision 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 |
Gogineni Mamata |
| Designation |
IOL FELLOW |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of General ophthalmology,first floor,Sankara Eye Hospital ,
Pedakakani,Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9704643753 |
| Fax |
|
| Email |
mamatagogineni95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sailaja P |
| Designation |
Consultant |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room 136, Ground floor,Sankara Eye Hospital ,
Pedakakani,Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9440778499 |
| Fax |
|
| Email |
sailaja.palukuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gogineni Mamata |
| Designation |
IOL FELLOW |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of General Ophthalmology,First floor,Sankara Eye Hospital ,
Pedakakani,Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9704643753 |
| Fax |
|
| Email |
mamatagogineni95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara eye hospital , Guntur,AndhraPradesh, India,522509 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Pedakakani, Guntur 522509 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DRGogineni Mamata |
sankara eye hospital,First floor,Department of general ophthalmology |
Pedakakani
Guntur
522509
Guntur
ANDHRA PRADESH |
9704643753
mamatagogineni95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara eye Hospital, Sri Kanchi Kamakoti Medical Trust Institutional Ethics Committee |
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 |
| Intervention |
Subtenons anaesthesia and Peribulbar anaesthesia |
Drug used in both the procedures- 30 ml of 2% lignocaine mixed with 1500IU of hyaluronidase and 0.3 ml of adrenaline
In subtenons anaesthesia,3 ml of the drug is injected into subtenons space with 27G cannula
In Peribulbar Anaesthesia, 5 ml of drug is injected into peribulbar space
All the cases are operated by single surgeon |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with uncomplicated cataract |
|
| ExclusionCriteria |
| Details |
Patients with Small pupil less than 5mm size
Patients who are sensitive to xylocaine |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Analgesia
Akinesia
|
Analgesia - Immediately after administration of drug, At the end of surgery, 1 hour after surgery
Akinesia- 3 minutes after administration of drug,
1 hour after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any complication |
at the time of administration of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
16/04/2024 |
| 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 - 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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-11-2024 and end date provided 15-11-2026?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A comparative study of Subtenon’s anaesthesia with Peribulbar anaesthesia in manual small incision cataract surgery in terms of Analgesia and Akinesia immediately after administration of anesthesia, at the end of surgery and 1 hour after surgery |