| CTRI Number |
CTRI/2024/12/078534 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To Assess The efficacy of 2 different for peribulbar block in cataract surgery |
|
Scientific Title of Study
|
To Assess The efficacy of bupivacaine Vs levobupivacaine when combined with lignocaine and hyluronidase for peribulbar block in 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 |
Dr arvind sahu |
| Designation |
Junior Resident |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department Of Anaesthesiology,Gandhi Medical College,Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8989795546 |
| Fax |
|
| Email |
sahuarvind0007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R P kaushal |
| Designation |
HOD and Professor |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department Of Anaesthesiology,Gandhi Medical College,Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9617377131 |
| Fax |
|
| Email |
Rpkaushal1@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr surendra raikwar |
| Designation |
Professor |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department Of Anaesthesiology,Gandhi Medical College,Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8989118989 |
| Fax |
|
| Email |
drskraikwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| A block hamidia Hospital Department of Anaesthesiology Gandhi Medical College, Bhopal
462001 |
|
|
Primary Sponsor
|
| Name |
Hamidia hospital and gandhi medical college bhopal |
| Address |
Gandhi Medical College, Bhopal |
| 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 arvind sahu |
Hamidia hospital gandhi medical college bhopal |
Department Of Anaesthesiology,Gandhi Medical College,Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
8989795546
sahuarvind0007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional lethics commitee Gandhi Medical College Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H28||Cataract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
prior informed consent
schduled for cataract surgery |
|
| ExclusionCriteria |
| Details |
patient refusal
highly uncooperative patient
history of allergy for local anesthetic agents
ASA III and IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To study the onset of sensory and motor block by
Bupivacaine v/s Levobupivacaine with
lignocaine and hyaluronidase.
•To study the duration of analgesia and akinesia achieved with these drugs.
|
will be assessed at baseline 2 mins,5 mins 10 mins 20 mins and 30 mins
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To study the occurrence of complications related to Bupivacaine and Levobupivacaine with lignocaine and hyaluronidase |
will be assessed at baseline 2 mins,5 mins 10 mins 20 mins and 30 mins
|
|
|
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)
|
15/01/2025 |
| 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="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 - NO
|
|
Brief Summary
|
| For a perfect and uneventful cataract surgeries, atleast 1 to 1.5 hours time duration is needed for complete akinesia and analgesia to the patients. In cataract surgery, Peribulbar and Retrobulbar block has gained popularity over general anaesthesia as there is less hemodynamic instability,lessrespiratory depression, better post operative analgesia and less nausea & vomiting with regional anaesthesia, hence safer and more popular than general anaesthesia. | Peribulbar block is a rapid, simple & safe technique but requires larger volume of local anaesthetic solution to produce desired akinesia. The duration of the block depends on type and composition of local anaesthetic mixture injected. Hence, the present study will be carried out on local anaesthetic solution in peribulbar block to find out efficacy, duration, quality of block and side effect if any. The isomer of drugs might prolong the duration of block. So it could be better for cataract surgeries and with a better outcome. |