| CTRI Number |
CTRI/2016/04/006860 [Registered on: 22/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
31/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ENSURING CORRECT PLACEMENT OF EPIDURAL CATHETER FOR POST-OPERATIVE PAIN RELIEF |
|
Scientific Title of Study
|
A PROSPECTIVE OBSERVATIONAL STUDY TO ASSESS THE EFFICACY OF THE MENISCUS TEST IN PREDICTING THE CORRECT EPIDURAL CATHETER PLACEMENT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parmanand N Jain |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre Mumbai |
| Address |
Tata Memorial Hospital
DR.E. Borges Marg
PAREL
MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869480429 |
| Fax |
|
| Email |
pnj5@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreyas Bhor |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Centre Mumbai |
| Address |
Tata Memorial Hospital
DR.E. Borges Marg
PAREL
MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09096621721 |
| Fax |
|
| Email |
bhorshreyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parmanand N Jain |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre Mumbai |
| Address |
Tata Memorial Hospital
DR.E. Borges Marg
PAREL
MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869480429 |
| Fax |
|
| Email |
pnj5@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Marg, Parel, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Parmanand N Jain |
Tata Memorial Centre |
MB210
Operation theatre complex
2nd floor,main building
Tata Memorial Centre,Mumbai
Mumbai
MAHARASHTRA |
9869480429
pnj5@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult patients of both sexes of age 18-60 years
ASA I and II patients
Patients undergoing thoracoabdominal surgery
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of both sexes of age 18-60 years,
ASA I and II patients,
Patients undergoing thoracoabdominal surgery requiring postoperative epidural analgesia
|
|
| ExclusionCriteria |
| Details |
Patient refusal to epidural analgesia
Morbidly obese patient
Emergency surgery
Contraindications to central neuraxial blockade
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict correct Epidural catheter placement |
immediately after epidural catheter placement, epidural analgesia is tested. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict a functional epidural analgesia if Meniscus sign is positive |
immediately in postoperative period, when patient is initiated on epidural analgesia. |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
10/03/2015 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Ongoing study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To
assess the efficacy of the ’Meniscus test’ in confirming the correct placement
of epidural catheter in epidural space |