| CTRI Number |
CTRI/2022/10/046882 [Registered on: 28/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of intercostal nerve block and patient controlled analgesia on post thoracotomy pain in cardiac surgery patients |
|
Scientific Title of Study
|
To Comparison of intercostal nerve block v/s patient controlled intravenous Analgesia for post thoracotomy pain in cardiac surgery:a randomized interventional study at SMS medical college,jaipur-during 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drreema meena |
| Designation |
Senior professor |
| Affiliation |
Sms Hospital |
| Address |
Department of anaesthesiology,sawai man singh medical college and attached hospitals,adarsh nagar,jaipur
Department of anaesthesiology,sawai man singh medical college and attached hospitals,adarsh nagar,jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8619143319 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drreema meena |
| Designation |
Senior professor |
| Affiliation |
Sms Hospital |
| Address |
Department of anaesthesiology,sawai man singh medical college and attached hospitals,adarsh nagar,jaipur
Department of anaesthesiology,sawai man singh medical college and attached hospitals,adarsh nagar,jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8619143319 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr renu garg |
| Designation |
Junior resident |
| Affiliation |
Sawai man Singh medical College and attached hospital,jaipur |
| Address |
Department of anaesthesiology,Sawai man Singh medical College and attached hospital,adarsh nagar,jaipur
Department of anaesthesiology,Sawai man Singh medical College and attached hospital,adarsh nagar,jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
09571521632 |
| Fax |
|
| Email |
renugarg199593.rg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,Sawai man Singh medical College and attached hospitals |
|
|
Primary Sponsor
|
| Name |
Sawai man singh medical college and hospital |
| Address |
Department of anaesthesiology, sawai man singh medical college and attached hospitals jaipur |
| 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 reema meena |
Sawai man Singh medical college |
Department of anaesthesia,sms medical college,adarsh nagar,jaiput
Jaipur
RAJASTHAN |
9413237117
reemadrrn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committee Sms medical college and attached hospitals jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intercostal nerve block |
Group-A post operative analgesia in patient undergoing thoracotomy by intercostal nerve block technique(by using 2.5mg/kg of 0.5% ropivacaine + PCIA using normal saline and rescue analgesia provided in the form of 0.5-1mcg/ml iv fentanyl |
| Comparator Agent |
Patient controlled intravenous analgesia |
Group-B post operative analgesia in patient undergoing thoracotomy by patient controlled intravenous analgesia (by using fentanyl mcg/ml at a basal infusion rate of 1ml/hour and a bolus of 1ml(fentanyl 25mcg) with a lockout interval of 15 minutes) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) patients posted for thoracotomy of age group 30-60 years
2) ASA grade 2-3 |
|
| ExclusionCriteria |
| Details |
1) patients unable to perform visual analogue scale(VAS)
2) patients who had previous thoracic surgeries
3) patients having ropivacaine allergy
4) failure of the patient to properly use the PCA pump |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total consumption of injection fentanyl within 24hrs post operatively |
24hrs post operativel |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean sedation score
Mean vas score
Hemodynamic variables:-
Mean SBP
Mean SBP
Mean HR
Mean MAP
Side effects
|
24hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
15/11/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomised interventional study is conducted to find out which method of post operative analgesia is better in achieving better analgesic effect,stable post extubation hemodynamic,less side effects |