| CTRI Number |
CTRI/2025/08/093852 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| 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 effect of two different local anaesthetic drugs in anaesthesia for cataract surgery. |
|
Scientific Title of Study
|
Comparison of efficacy of 2% lidocaine and 0.5% bupivacaine with 2% lidocaine and 0.75% ropivacaine in peribulbar block for 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 |
Athira Ajayghosh |
| Designation |
Postgraduate ( MS Ophthalmology) |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of ophthalmology,
Srm medical college and research centre,
Srm university,
Kattankulathur,
Tamil Nadu.
Sakunthala vihar,
Kannamba,
Varkala.p.o,
Thiruvananthapuram,
Kerala
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9071945773 |
| Fax |
|
| Email |
athiraajayghosh15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Venkatesan C |
| Designation |
Head of department of Ophthalmology |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of ophthalmology,
SRM medical college and research centre,
Srm university,
Kattankulathur
Sakunthala vihar,
Kannamba,
Varkala.p.o,
Thiruvananthapuram,
Kerala
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9071945773 |
| Fax |
|
| Email |
athiraajayghosh4777@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
ATHIRA AJAYGHOSH |
| Designation |
Postgraduate ( MS Ophthalmology) |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of ophthalmology,
SRM medical college and research centre,
Srm university,
Kattankulathur
Sakunthala vihar,
Kannamba,
Varkala.p.o,
Thiruvananthapuram,
Kerala
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9071945773 |
| Fax |
|
| Email |
athiraajayghosh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college hospital and research centre,
Srm university,
Kattankulathur,
Chengalpattu district,
Tamil Nadu,
India.
Pincode: 603203
|
|
|
Primary Sponsor
|
| Name |
Athira Ajayghosh |
| Address |
Department of Ophthalmology,
SRM Medical college hospital and research centre, Srm university, Kattankulathur, Chengalpattu district, Tamil Nadu, India. Pincode: 603203 |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 |
| Athira Ajayghosh |
SRM Medical college hospital and research centre |
SRM Medical college hospital and research centre, Srm university, Kattankulathur, Chengalpattu district, Tamil Nadu, India. Pincode: 603203 Kancheepuram TAMIL NADU |
9071945773
athiraajayghosh15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethicscommiteesrmmedicalcollegehospitalandresearchcentre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lidocaine and 0.5% bupivacaine in peribulbar block for cataract surgery |
same procedure as above. |
| Intervention |
2% lidocaine and 0.75% ropivacaine in peribulbar block for cataract surgery |
The peribulbar block was administered while the patients maintained a primary gaze. A needle measuring 26G and 25 mm in length was introduced at the inferotemporal region, specifically at the point where the medial two-thirds and lateral one-third of the lower orbital rim intersect. The needle was guided along the floor of the orbit into the lateral extraconal area. After confirming no blood was aspirated, 5 ml of anaesthetic solution was administered. Subsequently, a second injection of 3 ml was delivered to the superonasal area. This was done by inserting the needle through the upper eyelid above the medial limbus, targeting the medial extraconal space. Gentle massage was applied to facilitate the spread of the anaesthetic.
Sensory block was assessed by loss of corneal sensation with cotton whisp at 2, 4, 6, 8, and 10-minute intervals after injection. Onset of sensory block was taken as time from injection to loss of corneal sensation.
Motor block was evaluated in the four quadrants using a 3-point scoring system.
0- Akinesia (ocular movement lesser than1mm),
1- reduced movement (ocular movement greater than 1mm but lesser than 4mm),
2- normal movements ((ocular movement greater than 4mm).
This scoring system gives a maximal aggregate score of 8 for the four muscles. A total score of less than or equal to 2 indicated a successful block. Once successful block is attained, no further assessment made.
Haemodynamic parameters, including systolic, diastolic, and mean arterial pressures, heart rate, and oxygen saturation, were monitored at 1, 3, 5, 8, 10, and 15 min, and every 10 min thereafter until the surgery was concluded. All patients received supplemental oxygen at 4 L per min via a nasal cannula.
The quality of the surgical anaesthesia was graded as excellent (no pain), good (minimal pain), or poor (failed block).
Postoperatively, pain was assessed using the Visual Analogue Scale (VAS) every 15 min until the score reached greater than or equal to 3, at which point patients received oral paracetamol 650 mg as rescue analgesia. The duration of effective analgesia was recorded from the time of the peribulbar block to the point when the VAS score reached greater than or equal 3. The resolution of motor blockade was not assessed because the patient’s eyes were bandaged postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
44.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with immature or mature cataracts, patients aged above 44 years old and patients experiencing cataract-related symptoms, such as cloudy vision, light sensitivity, or increasing short-sightedness, who have a maximum corrected visual acuity of 6/60 or higher. |
|
| ExclusionCriteria |
| Details |
Local sepsis, glaucoma, serious impairment of coagulation, orbital abnormalities, patient’s refusal, un-cooperative patients and patients are unable to lie supine for a long time. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sample size is calculated and found to be 184, divided into two groups, 82 in each. Sensory and motor blockade onset were assessed at regular intervals, and postoperative analgesia duration was measured. |
Peribulbar block is given. Sensory block is assessed by corneal sensation at 2min intervals till loss of sensation. Motor block is evaluated at 2min interval. Postoperatively pain is assessed using the VAS every 15 min. The duration of effective analgesia is recorded from the time of block to point when VAS score reached more than or equal 3. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="184" Sample Size from India="184"
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 3 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="1" Months="6" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vageeshatmsrm@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Cataract surgery is commonly performed under regional anaesthesia using peribulbar blocks. The combination of local anaesthetic agents significantly affects the onset, duration, and efficacy of anaesthesia. This study aimed to compare the efficacy of peribulbar anaesthesia using 2percent lidocaine with 0.75percent ropivacaine versus 2percent lidocaine with 0.5percent bupivacaine in terms of sensory blockade onset, motor blockade onset, and postoperative analgesia duration. Study to be conducted on 164 patients undergoing cataract surgery, who are divided into two groups. One group receive an 8 ml mixture of 2percent lidocaine and 0.75percent ropivacaine, while the control group receive 2percent lidocaine and 0.5percent bupivacaine. The peribulbar block is administered while the patients maintained a primary gaze. Gentle massage is applied to facilitate the spread of the anaesthetic. Sensory block wis assessed by loss of corneal sensation with cotton whisp at 2, 4, 6, 8, and 10 min intervals after injection. Onset of sensory block is taken as time from injection to loss of corneal sensation. Motor block is evaluated in the four quadrants using a 3-point scoring system [Akinesia (ocular movement lesser than1mm), reduced movement (ocular movement greater than 1mm but lesser than 4mm) and normal movements (ocular movement greater than 4mm)]. A total score of less than or equal to 2 indicates a successful block. Once successful block is attained, no further assessment made. Haemodynamic parameters, including systolic, diastolic, and mean arterial pressures, heart rate, and oxygen saturation to be monitered . The quality of the surgical anaesthesia is graded as excellent (no pain), good (minimal pain), or poor (failed block). Postoperatively, pain is assessed using the Visual Analogue Scale (VAS) every 15 min until the score reached greater than or equal to 3. The duration of effective analgesia is recorded from the time of the peribulbar block to the point when the VAS score reached greater than or equal 3. The resolution of motor blockade cant be assessed because the patient’s eyes bandage postoperatively. |