| CTRI Number |
CTRI/2020/09/027745 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting entry point for epidural catheter insertion in the upper back region - a study |
|
Scientific Title of Study
|
Predicting clinical entry point for thoracic epidural catheter insertion during para-median approach - A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumitra Bakshi |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Mumbai 400012, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhakti Deshmukh |
| Designation |
Junior Resident, Department of Anaesthesia, Critical care and Pain |
| Affiliation |
Department of Anaesthesia, Critical care and Pain |
| Address |
Tata Memorial Hospital, Parel , Mumbai 400012
Tata Memorial Hospital, Parel , Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
dbhakti101@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhakti Deshmukh |
| Designation |
Junior Resident, Department of Anaesthesia, Critical care and Pain |
| Affiliation |
Department of Anaesthesia, Critical care and Pain |
| Address |
Tata Memorial Hospital, Parel, Mumbai 400012
Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
dbhakti101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, critical care and pain, Tata memorial hospital, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
HOMI BHABHA national institute thesis fund |
| Address |
13th floor, Homi Bhabha block academic office |
| 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 |
Tata Memorial Hospital |
Main ot complex,
2nd flood main building,
Parel Mumbai 400012
Mumbai
MAHARASHTRA |
24177058
sumitrabakshi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata memorial hospital, Parel Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients > 18 years of age, undergoing thoracic or abdominal surgeries under general anaesthesia with epidural analgesia attempted at the mid thoracic level T5-T8 |
|
| ExclusionCriteria |
| Details |
Obvious spine deformities (or kypo/ scoliosis)
Previous spine surgeries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find correlation between a successful epidural puncture point to standard anatomical landmark – which includes the distance from midline, distance from upper and lower border of upper and lower spine of the desired space. |
Immediate post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To note the number of passes needed to locate the space from the successful puncture point. 2. total number of attempts taken on an average to locate the epidural space, each fresh skin puncture being defined as an attempt. 3. Incidence of failed epidural (abandoned procedure, negative band on ice test postoperatively) 4. Other factors that affect epidural outcome – age, BMI, gender, ease of palpation of bony landmarks |
Immediate post-operative period |
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
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)
|
10/09/2020 |
| 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="10"
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)?
|
|
Brief Summary
|
This is a prospective observational study to correlate the chances of success of paramedian approach of thoracic epidural catheter insertion with respect to standard landmarks mainly the distance with respect to spinal midline and from upper and lower border of upper and lower spine of the intended epidural space. Primary objective is to find correlation between successful epidural puncture point to standard anatomical landmark – which includes the distance from midline, distance from upper and lower border of upper and lower spine of the desired space. Secondary objectives are to note the number of attempts and number of passes in each attempt for locating epidural space, the failure rate of procedure ,other factors ( age,sex BMI ) affecting it.
Study methodology : For each attempt at the epidural space, an observer will record the number of attempts and passes and the performing anaesthesiologist will convey to the observer the most suitable option with respect to available landmarks choosen. Once the catheter is placed, the observer with the measuring tape will record the distance from midline with the help of measuring tape .The attempt will be marked as successful only after confirmation of anaesthetic band in the postoperative period.
Parameters to be recorded: • Factors that can affect the epidural outcome including age, sex, BMI, the landmarks • The total number of passes for the successful puncture point & total number of attempts taken will be noted. • Final outcome of epidural catheter insertion attempt abandoned / successful/ failure
Statistical Analysis: Primary end point – success will be compared with various end points using Chi square or Fischer exact test . For secondary outcomes, Chi square test will be used for categorical variable and student t test for continuous data |