| CTRI Number |
CTRI/2024/04/065518 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Usage of Color flow Doppler for confirming the final position of Epidural Catheter. |
|
Scientific Title of Study
|
Confirmation of epidural catheter placement in epidural space using ultrasound color flow doppler - a prospective observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Mahendra kumar |
| Designation |
DNB resident |
| Affiliation |
Sakra World Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SAKRA WORLD HOSPITAL, DEVARABISANAHALLI, BANGALORE
DEVARABISANAHALLI, VARTHUR HOBLI, BANGALORE
Bangalore
KARNATAKA
560103
India |
| Phone |
9566254266 |
| Fax |
|
| Email |
Mahendra1089462@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DHANANJAY DN |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
SAKRA WORLD HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SAKRA WORLD HOSPITAL, DEVARABISANAHALLI, BANGALORE
Bangalore
KARNATAKA
560103
India |
| Phone |
08073687393 |
| Fax |
|
| Email |
DHANANJAYDN@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR DHANANJAY DN |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
Sakra World Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SAKRA WORLD HOSPITAL, DEVARABISANAHALLI, BANGALORE
Bangalore
KARNATAKA
560103
India |
| Phone |
8073687393 |
| Fax |
|
| Email |
DHANANJAYDN@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY
SAKRA WORLD HOSPITAL, DEVARABISANAHALLI, BANGALORE 560103, KARNATAKA, INDIA |
|
|
Primary Sponsor
|
| Name |
SAKRA WORLD HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SAKRA WORLD HOSPITAL, DEVARABISANAHALLI, BANGALORE 560103, KARNATAKA , INDIA |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 DHANANJAY DN |
SAKRA WORLD HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, 2ND FLOOR, OPERATION THEATRE,
SAKRA WORLD HOSPITAL, DEVARABISANAHALLI, BANGALORE 560103
Bangalore
KARNATAKA |
8073687393
DHANANJAYDN@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SAKRA WORLD HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
undergoing elective surgeries under epidural anaesthesia |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing surgery under combined spinal epidural anaesthesia
belonging to ASA physical status 1,2 |
|
| ExclusionCriteria |
| Details |
patients who deny informed consent
patients with history of lumbar spine surgery
allergy to local anaesthetics
coagulation abnormalities
suspected infection at local site
pregnancy
ASA physical status 3,4,5
covid positive patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Confirmation of Epidural catheter placement in the Epidural space using ULTRASOUND COLOUR DOPPLER. |
AT THE TIME OF PROCEDURE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Catheter tip visualization and
Catheter migration |
AT THE TIME OF THE PROCEDURE |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
20/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
TRADITIONALLY, EPIDURAL SPACE IS IDENTIFIED BY LOSS OF RESISTANCE TECHNIQUE, WHIUCH WAS FIRST DESCRIBED BY SICARD AND FORESTIER IN 1921. INCORRECT PLACEMENT OF EPIDURAL CATHETER IS REPORTED TO OCCUR IN 12-40% OF THE CASES. FAILURE TO CORRECTLY PLACE A EPIDURAL CATHTER LEADS TO INADEQUATE ANALGESIA AND SERIOUS COMPLICATIONS LIKE DURAL PUNCTURE HEADACHE. SINCE, THE SUCCESS OF EPIDURAL ANALGESIA DEPENDS ON THE LOCATION OF THE EPIDURAL CATHETER IN THE EPIDUAL SPACE, A SIMPLE AND NON INVASIVE BEDSIDE METHOD TO CONFIRM ITS LOCATION WOULD BE BENEFICIAL. ULTRASOUND IS NON INVASIVE AND GIVES A SIGNIFICANT AND ACCURATE INFORMATION REGARDING THE FLOW ACROSS ANY AREA. HENCE WE PROPOSE TO UTILISE THE ULTRASOUND TO CONFIRM THE CORRECT PLACEMENT OF THE EPIDURAL CATHETER USING THE COLOUR FLOW DOPPLER. |