| CTRI Number |
CTRI/2018/03/012690 [Registered on: 21/03/2018] Trial Registered Prospectively |
| Last Modified On: |
20/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
studying clinical efficacy of ultrasound guided epidural |
|
Scientific Title of Study
|
Ease of lumbar epidural catheter insertion with prepuncture ultrasound as guidance compared with conventional palpatory technique-A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jagadish A |
| Designation |
JR |
| Affiliation |
JIPMER |
| Address |
Department of anaesthesia,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9445920019 |
| Fax |
|
| Email |
jaga2992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SrinivasanS |
| Designation |
Assistant professor |
| Affiliation |
JIPMER |
| Address |
anaesthesia office,old building, Department of anaesthesia,
JIPMER,
dhanvantri nagar,
puducherry.
department of anaesthesia,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9626493045 |
| Fax |
|
| Email |
srinianaes@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jagadish A |
| Designation |
JR |
| Affiliation |
JIPMER |
| Address |
Department of anaesthesia,
JIPMER
PONDICHERRY
605006
India |
| Phone |
9445920019 |
| Fax |
|
| Email |
jaga2992@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri nagar,Gorimedu,puducherry-605006 |
| 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 |
| Jagadish A |
Jipmer |
Dhanvantri nagar,Gorimedu,pondicherry
Pondicherry
PONDICHERRY |
9445920019
jaga2992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Elective surgical patient requring lumbar epidural, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group p |
Placing epidural using normal palpatory method |
| Intervention |
Group u |
Prepuncture ultrasound guided epidural placement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Asa 1-3,
Elective procedure requring lumbar epidural |
|
| ExclusionCriteria |
| Details |
H/o lumbar spine surgery,
Patient refusal,
Coagulation abnormalities,
Local site infection,
Severe hepatic and renal impairment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. insertion attempts |
1. insertion attempts |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. successful epidural catheter insertion
2. dural puncture
3.ease of insertion |
1.time taken
2.frequency
3.ease of insertion acclrding to likerts scale |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/06/2018 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to compare clinical efficacy of the pre-puncture ultrasound and palpatory method 0f securing epidural.
|