| CTRI Number |
CTRI/2025/04/084238 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to Investigate whether a medication called Hyaluronidase, used to help Local Anesthesia work better, has any effect on eye pressure in patients undergoing Cataract Surgery. |
|
Scientific Title of Study
|
Effect on intraocular pressure of inj hyaluronidase used as an adjuvant to local anaesthesia for peribulbar block in cataract - a prospective randomized double blinded comparative 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 Manisankar Nath |
| Designation |
Assistant Professor |
| Affiliation |
Jalpaiguri Govt Medical College and hospital |
| Address |
Office of the Principal, Jalpaiguri Govt Medical College and Hospital. Hospital Road. Jalpaiguri.
Jalpaiguri
WEST BENGAL
735101
India |
| Phone |
9434875617 |
| Fax |
|
| Email |
manisankarnath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisankar Nath |
| Designation |
Assistant Professor |
| Affiliation |
Jalpaiguri Govt Medical College and hospital |
| Address |
Office of the Principal, Jalpaiguri Govt Medical College and Hospital. Hospital Road. Jalpaiguri.
Jalpaiguri
WEST BENGAL
735101
India |
| Phone |
9434875617 |
| Fax |
|
| Email |
manisankarnath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisankar Nath |
| Designation |
Assistant Professor |
| Affiliation |
Jalpaiguri Govt Medical College and hospital |
| Address |
Office of the Principal, Jalpaiguri Govt Medical College and Hospital. Hospital Road. Jalpaiguri.
Jalpaiguri
WEST BENGAL
735101
India |
| Phone |
9434875617 |
| Fax |
|
| Email |
manisankarnath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of the Principal, Jalpaiguri Govt Medical College & Hospital, Hospital Road, P.O- Jalpaiguri, Dist.- Jalpaiguri, West Bengal, PIN-735101. |
|
|
Primary Sponsor
|
| Name |
Office of the Principal, Jalpaiguri Govt Medical College |
| Address |
Department of Anesthesiology,
Jalpaiguri Govt Medical College & Hospital,
Jalpaiguri, West Bengal -735101. |
| Type of Sponsor |
Government 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 Manisankar Nath |
Jalpaiguri Govt Medical College and Hospital |
Eye Operation Theatre, Department of Ophthalmology, Sadar Hospital Road, P.O-Jalpaiguri, PIN-735101
Jalpaiguri
WEST BENGAL |
9434875617
manisankarnath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jalpaiguri Government Medical College and Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peribulbar block with LA with added inj hyaluronidase. |
60 patients in group 1 will receive peribulbar block with inj hyaluronidase added to local anaesthetic mixture of inj Lignocaine & Bupivacaine. IOP will be measured at four time-points: before block (control), one minute after block, five minutes after block, and 15 minutes after block with a hand held air puff tonometer. |
| Comparator Agent |
Peribulbar block with LA without added Inj hyaluronidase. |
60 patients in group 2 will receive peribulbar block with local anaesthetic mixture of inj Lignocaine & Bupivacaine without adding inj hyaluronidase. IOP will be measured at four time-points: before block (control), one minute after block, five minutes after block, and 15 minutes after block with a hand held air puff tonometer.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
- ASA I,II,III patients
- Normal IOP (10-20 mm Hg)
- Normal baseline ECG
- BP less than 160/90 mm Hg
- CBG less than 200 mg/dl
- Axial length of globe is 22-25 mm and in gonioscopy patient has open angle.
- Cataract Operation under peribulbar block. |
|
| ExclusionCriteria |
| Details |
- hypersensitivity to hyaluronidase
- hypersensitivity to any components of the injection.
- pre existing ocular pathology, trauma or ocular movement restriction
- pre existing glaucoma, high myopia or hypermetropia, eveitis
- previous ocular surgery like vitrectomy, trabeculectomy
- patient at increased risk for thrombosis
- patient receiving salicylates, ACTH, cortisone, estrogen
- patients with profound cognitive impairment, apprehension, requiring sedatives and analgesics,
- unwillingness to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraocular pressure before and after peribulbar block with or without added inj hyaluronidase. |
Pre block and post block 1 min, 5 min,15 mins after block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vital parameters - HR, NIBP, SpO2 |
Pre block and post block every 3 mins. |
| Block quality |
10 mins after block |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/04/2025 |
| 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
|
After getting institutional ethnic committee approval, CTRI registration and written informed consent from all 120 patients, fulfilling inclusion criteria undergoing cataract surgery under peribulbar block will be taken in our study. All patients will be allocated randomly according to the computer generated random numbers into two groups of 60 patients in each group. Group 1 (n= 60) will receive peribulbar block with adjuvant inj hyaluronidase and Group 2 (n= 60) will receive peribulbar block without inj hyaluronidase. For double blinding purpose, all study drug administration will be done by another anesthesiologist who followed opaque sealed envelope technique and will not be part of the study. Another Anesthesiologist will collect data of patients. Patients will also be blinded to the study drug. All patients will have a pre operative full history taking and general physical examination. Vital parameters such as blood pressure, heart rate and random blood sugar level will be measured. Ophthalmic examination will be done by the ophthalmologist. Pre block (control) IOP will be measured by a hand held air puff tonometer. Before the procedure tropicamide 0.8% and Phenylephrine 5% dilating eye drops will be instilled into the eye to be operated as per protocol followed in our institution. The eye to be operated will be painted and draped with 5% povidone iodine soluion. A 24 gauge disposable needle will be used and site of injection will be the point between medial 2/3 and lateral 1/3 of lower orbital margin adjacent to infraorbital notch. After negative aspiration, 6 ml local anaesthetic mixture will be injected over 30-40 seconds Group 1 will receive Local anaesthetic mixture of 1:1 2% Lignocaine plus 0.5% Bupivacaine with added adjuvant inj hyaluronidase (50 IU/ml) . Group 2 will receive local anaesthetic mixture without added hyaluronidase. After injection globe will be massaged and gentle pressure will be applied for 1 min. IOP will be measured at four time points - pre block ( control ), post block after 1 min, 5 min and 15 mins. All the study parameters according to time interval will be documented. |