| CTRI Number |
CTRI/2014/09/004963 [Registered on: 03/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
28/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
APAD a simpler technique for localization of epidural space for epidural anesthesia. |
|
Scientific Title of Study
|
Comparison of APAD vs Loss of resistance technique for localization of epidural space |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Amit Kumar Mittal |
| Designation |
Consultant |
| Affiliation |
RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE |
| Address |
Department of Anesthesia,RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE,Sector-5 Rohini ;New Delhi -110085
RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE,Sector-5 Rohini ;New Delhi -110085
North West
DELHI
110085
India |
| Phone |
91-11-47022323 |
| Fax |
91-11-27051037 |
| Email |
mittal.amit@rgcirc.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Amit Kumar Mittal |
| Designation |
Consultant |
| Affiliation |
RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE |
| Address |
Department of Anesthesia,RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE,Sector-5 Rohini ;New Delhi -110085
RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE,Sector-5 Rohini ;New Delhi -110085
North West
DELHI
110085
India |
| Phone |
91-11-47022323 |
| Fax |
91-11-27051037 |
| Email |
mittal.amit@rgcirc.org |
|
Details of Contact Person
Public Query
|
| Name |
DR Amit Kumar Mittal |
| Designation |
Consultant |
| Affiliation |
RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE |
| Address |
Department of Anesthesia,RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE,Sector-5 Rohini ;New Delhi -110085
RAJIV GANDHI CANCER INSTITUTE AND RESARCH CENTRE,Sector-5 Rohini ;New Delhi -110085
North West
DELHI
110085
India |
| Phone |
91-11-47022323 |
| Fax |
91-11-27051037 |
| Email |
mittal.amit@rgcirc.org |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute sector-5 rohini delhi 110085 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute |
| Address |
Department of anaesthesiology,Rajiv Gandhi Cancer Institute sector-5 rohini delhi 110085 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nitesh Goel |
Department of anaesthesiology,Rajiv Gandhi Cancer Institute sector-5 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Kumar Mittal |
Department of anaesthesia ,OT complex,Rajiv Gandhi Cancer Institute And Research Centre |
Sector-5 Rohini
North West
DELHI |
9717611416
mittal.amit@rgcirc.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB- RGCI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Physical Status I-III, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
localization of epidural space
|
not applicable |
| Comparator Agent |
Comparator 1 Using APAD device
|
APAD (Acoustic Puncture assist device ) this device was manufactured by Biosensors B.V ,Arnoudstraat, Netherlands.there is pressure monotring kit which sense and display the change in pressure while locating epidural space into both aucoctic and visual ( graphical trace on monitor )pattren
|
| Comparator Agent |
loss of resistance technique |
in this technique there is sudden give way as the epidural space is localized due to negative pressure in the space. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA : I-III
Pelvic, perineal ,lowerlimb or abdominal surgery
|
|
| ExclusionCriteria |
| Details |
Localsite infection
Patient unwillingness
Any coagulopathy
Spine abnormality/ surgery
Obesity (BMI>29)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Successful catheter placement in epidural space is primary outcome confirmed by below mentioned tests 1:Epidural pressure waveform confirmation for proper catheter placement has 100% specificity and positive predictive value and sensitivity of 80%.
2:clinical confirmations using segmental field block by injecting local anesthetic through catheter and assessment using pin prick method after 5 minutes. |
not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Less discomfort to patient while giving position during procedure and lesser expected complications |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/05/2014 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a
prospective randomized single blinded control trial , comparing APAD
localization of epidural space with loss of resistance technique . Primary aim
of this study is to locate epidural
space by using any one of the technique.
Secondary Objectives were to find the correlation
between sonographic depth and procedural depth ,to record the time taken to
perform individual technique and to assess the number of patients developing
adverse event or complications in terms of dural puncture, nerve injury, PDPH .
In this
study randomization was done using computer generated randomization ,and
sequentially numbered sealed envelopes were allocated to patients .then
patients were explained about the
technique with complete explanation about the benefits and drawbacks of technique in their own language, once they
agreed , one of the investigator will perform ultrasound of spine and mark the
space ,and gives its measurement of epidural depth to outcome assessor . now
the other investigator will perform procedure for epidural catheter placement
as per the group allocated in sealed envelop ,now outcome assessor will record the time time
taken to locate the epidural space, number of space tried , redirection of
needle ,success of technique , placement of catheter any complications as per Performa
and finally the VAS score given by patient. |