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CTRI Number  CTRI/2024/11/076909 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   An Observational study to detect the effect of Interscalene block on the pressures of the eyes in Patients undergoing arm, forearm and hand elective surgeries. 
Scientific Title of Study   Effect of Interscalene Block on Intraocular Pressure and Ocular Perfusion Pressure in Upper Limb Surgeries: An Observational 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 Ashwini A 
Designation  Professor 
Affiliation  Kempegowda Institute of Medical Sciences , Bangalore, Karnataka, India 
Address  Dr Ashwini A, Professor, Department of Anaesthesiology , Kempegowda Institute of Medical Sciences , Bangalore, Karnataka, India

Bangalore
KARNATAKA
560004
India 
Phone  9880490917  
Fax    
Email  ashvj30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrisha Hiremath 
Designation  Postgraduate student 
Affiliation  Kempegowda Institute of Medical Sciences , Bangalore Karnataka, India 
Address  Dr Shrisha Hiremath , Postgraduate student, Department of Anaesthesiology, Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India

Bangalore
KARNATAKA
560004
India 
Phone  8792472917  
Fax    
Email  shri_hir@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shrisha Hiremath 
Designation  Postgraduate student 
Affiliation  Kempegowda Institute of Medical Sciences , Bangalore, Karnataka, India 
Address  Dr Shrisha Hiremath , Postgraduate student , Department of Anaesthesiology, Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India

Bangalore
KARNATAKA
560004
India 
Phone  8792472917  
Fax    
Email  shri_hir@yahoo.com  
 
Source of Monetary or Material Support  
Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India-560004 
 
Primary Sponsor  
Name  Dr Shrisha Hiremath 
Address  Dr Shrisha Hiremath, Postgraduate, Department of Anaesthesiology, Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India-560004 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrisha Hiremath  Kempegowda Institute of Medical Sciences, Bangalore  Room No. 1, Department of Anaesthesiology, 4th Floor,OT Complex, A Block , Kempegowda Institute of Medical Sciences, V V Puram, Bangalore, Karnataka, India 560004
Bangalore
KARNATAKA 		 8792472917

shri_hir@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Kempegowda Institute of Medical Sciences, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients posted for elective upper limb surgeries. Also, Patients belonging to ASA 1 and 2 according to American Society of Anaesthesiologists Physical status classification  
 
ExclusionCriteria 
Details  1. Patients already diagnosed to have glaucoma, cataract.
2. Patients with contraindications to brachial plexus blocks (coagulopathies, severe respiratory disease, contralateral phrenic nerve paralysis).
3. Patients diagnosed to have Horner’s syndrome in the past or bell’s palsy or diagnosed to have stroke or head injury in the past.
4. Patients proved to have allergic/ hypersensitivity to local anaesthetics.
5. Pre-existing acute or chronic eye disease or had eye injury /penetrating ocular injury in the past or had history of eye surgery
6. Use of ß blockers, Ca channel blockers, statins and nitrates which influence IOP
7. Pregnant females .
8. Patients who refuse to take part in study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intraocular Pressure  0,5,10,15,20,25,30,35,40,45,50,55,60th Minute 
 
Secondary Outcome  
Outcome  TimePoints 
Ocular Perfusion Pressure   0,5,10,15,20,25,30,35,40,45,50,55,60th Minute 
 
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)   28/11/2024 
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="2"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

TITLE :EFFECT OF INTERSCALENE BLOCK ON INTRAOCULAR PRESSURE AND OCULAR PERFUSION PRESSURE IN UPPER LIMB SURGERIES: AN OBSERVATIONAL STUDY.

Keywords: Interscalene Block, Ocular Perfusion Pressure, Intraocular pressure, Mean arterial pressure.

Introduction:. Interscalene block(ISB) causes changes in Intraocular pressure(IOP) and Ocular perfusion pressure(OPP) as it blocks cervical sympathetic ganglia innervating ciliary blood vessels which are major source of  Aqueous humour production.

Methods: After Institutional Ethical Clearance(KIMS/IEC/A152/M/2024), Prospective observational study for period of 6 months, with sample size 80 (80 eyes=40 patients) will be started.  ASA I, II patients aged 18-60 posted for elective upper limb surgeries will be included after excluding glaucoma, cataract and patients contraindicated for ISB. 

Under USG guidance, ISB will be performed and Local anaesthetic=10ml Lignocaine(21.3mg/ml)+Adrenaline(0.005mg/ml)+10ml 0.5% Bupivacaine(5mg/ml) would be administered.

Post ISB Intraocular pressure (IOP) will be measured periodically using Easyton Trans-palpebral tonometer, on blocked side(case) and unblocked side(control eye) along with mean arterial pressure(MAP). 

OPP will be calculated using equation ,OPP=(95/140*MAP)-IOP. 

Repeated measures ANOVA will be used to test IOP and OPP difference in the blocked and unblocked eye at every 5 minutes after ISB (this will be done as per the planned time periods ).

 
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