| CTRI Number |
CTRI/2025/04/085580 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing various Anesthetic techniques for cataract surgery at a Tertiary care eye hospital |
|
Scientific Title of Study
|
Comparative study of Sub-Tenons anaesthesia Vs intracameral Vs Peribulbar Anaesthesia for cataract surgery at a Tertiary care eye hospital |
| 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 PSS SOUJANYA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
HOD, Dept of Ophthalmology, ESIC Medical College & Hospital, Hyderabad |
| Address |
Department of Ophthalmology
ESIC Medical College & Hospital
Sanathnagar
Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
7396228294 |
| Fax |
|
| Email |
drsoujanyapss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PSS SOUJANYA |
| Designation |
ASSOCIATE PROFESSOR DEPARTMENT OF OPHTHALMOLOGY |
| Affiliation |
HOD, Dept of Ophthalmology, ESIC Medical College & Hospital, Hyderabad |
| Address |
Department of Ophthalmology
ESIC Medical College & Hospital
Sanathnagar
Hyderabad,Telangana,India.
Hyderabad
TELANGANA
500018
India |
| Phone |
7396228294 |
| Fax |
|
| Email |
drsoujanyapss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYANKA BEJJENKI |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Dept of Ophthalmology, ESIC Medical College & Hospital, Hyderabad |
| Address |
Department of Ophthalmology
ESIC Medical College & Hospital
Sanathnagar
Hyderabad,telangana,India.
Hyderabad
TELANGANA
500018
India |
| Phone |
9885494040 |
| Fax |
|
| Email |
drpriyanka1403@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology
ESIC Medical College and Hospital
Sanathnagar
Hyderabad 500018
Telangana
India |
|
|
Primary Sponsor
|
| Name |
Dr PSS SOUJANYA |
| Address |
Associate Professor
Department of Ophthalmology
ESIC Medical College and Hospital
Sanathnagar
Hyderabad 500018
Telangana
India |
| 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 PSS SOUJANYA |
ESIC MEDICAL COLLEGE AND HOSPITAL |
Department of Ophthalmology
Unit 1
Room No.4
ESIC MEDICAL COLLEGE AND HOPSITAL, SANATH NAGAR, HYDERABAD 500018
India
Hyderabad
TELANGANA |
7396228294
drsoujanyapss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical college & Hospital and ESIC Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intracameral anaesthesia techniques |
Comparing pre-op, intra-op and postoperative parameters of various anesthetic techniques. 24 hours |
| Comparator Agent |
peribulbar anaesthesia |
comparing pre-op, intra-op and postoperative parameters of various anesthetic techniques. 24 hours |
| Intervention |
Sub Tenons anaesthesia |
comparing pre-op, intra-op and postoperative parameters of various anesthetic techniques.
24 hours |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 20- 70 years presenting with cataract |
|
| ExclusionCriteria |
| Details |
patients age below 20 years and above 70 years. patients allergic to anesthetic drugs, poor mydriasis less than 5mm, known
case of epilepsy, anxiety or psychiatric disorder, inability to lie flat, inability to
understand the pain scale or to comply with instructions deafness, mental retardation are excluded
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief to the patient intraoperatively and post operatively with visual analogue scale(1 to 10),anxiety (Amsterdam Preoperative Anxiety and Information Scale), ease of doing surgery to the surgeon |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| anaesthesia related complications during the surgery intraoperatively and post operatively |
24 hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
This study aims to compare the effectiveness and adequacy of three different types of anaesthesia viz., Sub-Tenon’s, intracameral and peribulbar anaesthesia in cataract surgery in providing pain relief to the patient, ease of doing surgery to the surgeon and anaesthesia related complications during the surgery. The objectives of the study are to compare patients’ comfort levels during administration of anaesthesia intraoperatively and post operatively. All patients aged 20 - 70 years coming to ophthalmology OPD of ESIC medical college and hospital with cataract and planned for cataract surgery will be subjected to the study after taking informed consent. Patients will be divided into 3 groups using simple randomization. One group will be given sub-tenon’s anaesthesia, second group will be given peribulbar anaesthesia and the third group will be given intra cameral anaesthesia Patients undergoing the surgery will be questioned immediately after the completion of surgery on parameters such as anxiety (Amsterdam Preoperative Anxiety and Information Scale (APAIS)), pain assessment with visual analogue scale (1 to 10) pre operative, intra operative and post operative, akinesia scored 0 to 2 (0=Total akinesia ,1=Partial akinesia,2= No akinesia) and visual recovery. Patient’s comfort level is scored 1 to 5 (1-Pain/discomfort all the time, 2- Pain/Discomfort many times, 3- Occasional pain but tolerable, 4- Occasional discomfort but no pain and 5 – No pain/discomfort). Patient’s cooperation during the surgery is scored 1 to 5 (1- Repetitive instruction for fixation required [>5], 2- Often has to instruct [3- 5], 3- Few times instruction needed [2], 4- Very less often needed instruction [1], 5- No instruction required after starting surgery). Data on complications associated with type of anaesthetic technique will be noted. |