| CTRI Number |
CTRI/2013/01/003281 [Registered on: 02/01/2013] Trial Registered Prospectively |
| Last Modified On: |
24/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to know whether it is feasible to preoperatively check and confirm placement of an epidural catheter using 3cc of a drug called lignocaine 1% |
|
Scientific Title of Study
|
An observational study to assess the feasibility of pre operative confirmation of epidural catheter placement using 3cc of 1% lignocaine. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumitra Bakshi |
| Designation |
Associate Professor |
| Affiliation |
Department of Anesthesia, Critical Care and Pain,Tata Memorial Hospital, |
| Address |
1102, Gloriosa, Prin N.M.Kale Marg, Agar Bazar, Mumbai
Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial hospital Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400028
India
Borges Road, Parel, Mumbai-12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinayak Vanjari |
| Designation |
P.G. Student |
| Affiliation |
Tata Memorial Hospital |
| Address |
B-3 Kohir CHS, Patel estate road, Jogeshwari(W), Mumbai-400102
Dept. of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400102
India |
| Phone |
9821520950 |
| Fax |
|
| Email |
vinayakvanjari@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitra Bakshi |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
1102, Gloriosa, Prin N.M.Kale Marg, Agar Bazar, Mumbai
Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial hospital Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400028
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Dept of Anesthesia, Critical Care and Pain Tata Memorial Hospital Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr E Borges Road, 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 |
| Dr Sumitra Bakshi |
Main OT complex |
Second floor ,Main Building,OT complex, Tata Memorial Hospital,Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9869334449
sumitrabakshi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cancer patients for elective surgery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent agreed upon
Patients planned for epidural catheter insertion in induction room
ASA physical status I to II patients (hypertensive patients not included),
Aged 18 years or older,
Scheduled to undergo elective surgical procedures requiring epidural catheter placement
|
|
| ExclusionCriteria |
| Details |
All first cases in theatre.
Refusal to consent
Hypertensive patients
ASA physical status III and above
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Time taken for initial loss of temperature sensation
2) Extent of blockade (number of segments blocked; at end of 20 minutes),
3) Incidence of hypotension
|
1)The primary outcomes will be checked at 2,4,6,8,10,15,20 min after administration of local anesthetic. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of hypotension
|
Will be checked at 2,4,6,8,10,15,20 min |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study to assess the feasibility of preoperative confirmation of epidural catheter placement using 3cc of 1% lignocaine that will be conducted at a single centre in India. The primary outcome measures will be the time taken for initial loss of temperature sensation. The secondary outcomes will be the extent
of blockade (number of segments blocked; if less than 4 at end of 20 minutes) and the incidence of hypotension.
|