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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
Intervention / Comparator Agent
|
|
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. |