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CTRI Number  CTRI/2018/12/016640 [Registered on: 12/12/2018] Trial Registered Prospectively
Last Modified On: 27/02/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Patient satisfaction with different types of anesthesia in upper limb surgeries 
Scientific Title of Study   Patient satisfaction with regional anesthesia and general anesthesia in upper limb surgeries:a comparative study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Suresh  
Designation  Assistant Professor  
Affiliation  Kempegowda Institute of Medical Sciences (KIMS), Bangalore 
Address  Staff room of department of anesthesia, 4th floor, A block, Major OT complex, KIMS, KR Rd, Parvathipuram, Vishweshwarapura, Basavanagudi, Bengaluru
#682, 10th a main road, 36th cross road, Jayanagar 4th block, Bangalore Bangalore KARNATAKA 560004 India
Bangalore
KARNATAKA
560004
India 
Phone  9844828926  
Fax    
Email  priya1685@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priyanka Suresh  
Designation  Assistant Professor  
Affiliation  Kempegowda Institute of Medical Sciences (KIMS), Bangalore 
Address  Staff room of department of anesthesia, 4th floor, A block, Major OT complex, KIMS, KR Rd, Parvathipuram, Vishweshwarapura, Basavanagudi, Bengaluru
#682, 10th a main road, 36th cross road, Jayanagar 4th block, Bangalore Bangalore KARNATAKA 560004 India

KARNATAKA
560004
India 
Phone  9844828926  
Fax    
Email  priya1685@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priyanka Suresh  
Designation  Assistant Professor  
Affiliation  Kempegowda Institute of Medical Sciences (KIMS), Bangalore 
Address  Staff room of department of anesthesia, 4th floor, A block, Major OT complex, KIMS, KR Rd, Parvathipuram, Vishweshwarapura, Basavanagudi, Bengaluru
#682, 10th a main road, 36th cross road, Jayanagar 4th block, Bangalore Bangalore KARNATAKA 560004 India

KARNATAKA
560004
India 
Phone  9844828926  
Fax    
Email  priya1685@gmail.com  
 
Source of Monetary or Material Support  
Kempegowda Institute of Medical Sciences, Bangalore 
 
Primary Sponsor  
Name  Kempegowda Institute of Medical Sciences 
Address  KR Rd, Parvathipuram, Vishweshwarapura, Basavanagudi, Bengaluru, Karnataka  
Type of Sponsor  Private medical college 
 
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 
Priyanka Suresh  Department of anaesthesia, KIMS, Bangalore  taff room of department of anesthesia, 4th floor, A block, Major OT complex, KIMS, KR Rd, Parvathipuram, Vishweshwarapura, Basavanagudi, Bengaluru
Bangalore
KARNATAKA 
9844828926

priya1685@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee, KIMS, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with ASA physical status 1,2 and 3
2.Scheduled for upper limb surgeries under RA or GA
3.Would stay for at least 48 hours post-operatively
 
 
ExclusionCriteria 
Details  1.Patients other than ASA physical status 1, 2 and 3.
2.Patients on antiplatelet or anticoagulant drugs
3.ICU admitted patients
4.Patients having
a. Local infection at the site of block.
b. Bleeding coagulopathy.
c. Delirium or confusion of any cause.
d. Un co-operative patients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patient satisfaction  After 24 hours of surgery as soon as the patient becomes co-operative 
 
Secondary Outcome  
Outcome  TimePoints 
Total duration of hospital stay  Post operative period 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2019 
Date of Study Completion (India) 31/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

General anesthesia (GA) and regional anesthesia (RA) are the commonly practiced anesthetic procedures.  Two of the important factors in deciding the type of anesthesia to be administered are the involvement of patient or his caregivers in decision-making and the patient satisfaction. Patient satisfaction of the health care received is a multidimensional construct. It includes factors such as ease of the anesthetic procedure, adverse effects of anesthetic agents, emotional and interpersonal factors etc. Pascoe defined patient satisfaction as the patient’s reaction consisting of a “cognitive evaluation” and “emotional response” to the care they receive. Many of the sociodemographic factors, cultural influences and cognition of the patients are known to influence patient satisfaction.

In the upper limb surgeries PNB is the commonly practiced regional anesthesia procedure.  PNBs have been show to have clear edge over GA with respect to the many clinical variables. Advances in the PNBs have made them to be more acceptable among the patients, especially in North American and European countries.  In addition, RA has also been shown to have lesser cost compared with GA.

The more frequent administration of RA is very much required in the developing countries like India. More acceptability of RA by the patients would have significant economic implications on the cost of anesthetic procedures in a developing country like India.. In this context, it is quite essential to study the patient’s satisfaction with RA and GA and compare them. Such a study would also give an answer to the question of whether patient satisfaction differs between regional anesthesia and GA in the Indian population, in view of significant influence of psychosocial and cultural and factors in patient satisfaction. We could not come across any Indian study that has systematically evaluated and compared patient satisfaction between GA and RA

In this study we are assessing and comparing the patient satisfaction between RA and GA in subjects undergoing upper limb surgeries. In addition we would also compare the  length of stay in hospital between these two groups.

 
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