| CTRI Number |
CTRI/2021/09/036185 [Registered on: 02/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A prospective observational study comparing the effect of thoracic epidural analgesia (through insertion of epidural catheter) with intravenous analgesia in blunt trauma chest patient managed with non invasive ventilation |
|
Scientific Title of Study
|
A prospective observational study comparing the effect of epidural analgesia with intravenous analgesia in blunt trauma chest patients managed by non invasive ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Bhaskar |
| Designation |
Post graduate resident |
| Affiliation |
King George medical university |
| Address |
Department of anaesthesiology
King George medical university
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7348576807 |
| Fax |
|
| Email |
drbhaskar89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Singh |
| Designation |
Professor |
| Affiliation |
King George medical university |
| Address |
Department of anaesthesiology
King George medical university
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415520080 |
| Fax |
|
| Email |
saritacsmmu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Singh |
| Designation |
Professor |
| Affiliation |
King George medical university |
| Address |
Department of anaesthesiology
King George medical university
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415520080 |
| Fax |
|
| Email |
saritacsmmu@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
king george medical University
lucknow
uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Bhaskar |
| Address |
Department of anaesthesiology
King George medical university
Lucknow |
| Type of Sponsor |
Other [self] |
|
|
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 Sarita Singh |
King George Medical University |
Department of anaesthesiology
King George medical university
Lucknow
UTTAR PRADESH |
9415520080
saritacsmmu@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KGMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S224||Multiple fractures of ribs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine and fentanyl infusion will be infused from thoracic epidural for pain. |
Epidural Bupivacaine 0.125% with 100microgram fentanyl(2mcg/ml) will be given as 4ml bolus followed by infusion @ 4ml/hour for 72 hours |
| Comparator Agent |
Fentanyl intravenous infusion
to be given in blunt trauma chest patient for pain |
Fentanyl 2mcg/kg iv infusion will be given for 72 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients giving written consent will be taken
2) patient age 18 to 70 years
3)all blunt trauma chest patient not requiring surgical management |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)severe coagulopathy
3)infections at the site of puncture
4)unconscious patient
5)patient who require invasive mechanical ventilation will be excluded from study
6)facial trauma
7)Severe agitation
8)claustrophobia
9)copious secretions
10)uncontrolled vomting
11)Upper airway obstruction
12) Severe agitation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the effect of thoracic epidural analgesia with intravenous analgesia in blunt trauma chest patient managed with non invasive ventilation |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/09/2021 |
| 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="1"
Months="0"
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
|
Blunt trauma chest is one of the major injuries encountered in trauma victim and also leading cause of death from physical trauma after head injury. epidural analgesia for blunt thoracic injury has been demonstrated to beneficial for pulmonary function , analgesia and subjective pain and intravenous analgesia is also beneficial for blunt trauma chest patient managed with noninvasive ventilation |