| CTRI Number |
CTRI/2021/07/034773 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
11/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of pain relieving effects of Dural Puncture Epidural and Traditional Epidural in pregnant women who are in labour |
|
Scientific Title of Study
|
A study of Efficacy of Dural Puncture Epidural v/s Conventional Epidural Analgesia for Onset of Analgesia during Labour Analgesia among Parturients: A Randomized Controlled Trial |
| Trial Acronym |
EDPECELA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aarthy Kumaraguru |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Armed forces medical college
Dept of anaesthesiology
Wanwadi
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9791868822 |
| Fax |
|
| Email |
draarthykguru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikahat Jahan |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Anaesthesiology
Armed Forces Medical College
Wanwadi
Pune
MAHARASHTRA
411040
India |
| Phone |
9717270732 |
| Fax |
|
| Email |
nikahat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarthy Kumaraguru |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Armed forces medical college
Dept of anaesthesiology
Wanwadi
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9791868822 |
| Fax |
|
| Email |
draarthykguru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of anaesthesiology
Armed Forces Medical College
Wanwadi
Pune 411040 |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesiology |
| Address |
Armed Forces Medical College
Wanwadi Pune |
| Type of Sponsor |
Government medical college |
|
|
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 aarthy kumaraguru |
New Command hospital southern command |
Labour room
2nd floor block 02
Pune cantonment
Kondhwa Road
Pune 411001
Pune
MAHARASHTRA |
9791868822
draarthykguru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional epidural |
Only epidural catheter is placed without dural puncture |
| Intervention |
Dural puncture epidural |
Dura is punctured with spinal needle along with epidural catheter placement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Parturients presenting for normal vaginal delivery in active labour
Uncomplicated pregnancy
Vertex presentation
Cervical dilatation < 5 cm |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to drugs used for labour analgesia
Patients contraindicated for neuraxial analgesia
Bleeding disorders
Local or systemic sepsis
Blood/CSF in epidural catheter
Accidental dural puncture with epidural needle |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time of onset of analgesia following dural puncture epidural analgesia with that of conventional epidural analgesia given for labour analgesia to parturients in the labour room of tertiary care hospital using the VAS score |
After 5 minutes of the first bolus, the adequacy of analgesia will be assessed every 2 minutes till adequate analgesia is achieved ie. VAS less than 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia after the first dose |
At the time when the patient asks for first epidural top up |
| Incidence of side effects like hypotension |
Anytime after drug instillation |
| Incidence of post dural puncture headache |
After 24 to 48 hrs after the neuraxial analgesia |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
18/07/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Planning to publish in anaesthesia related journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Labour pains are considered to be the most painful events in the life of a woman. Neuraxial techniques have become the effective form of labour analgesia.labour epidural is considered the traditional technique for providing labour analgesia. Dural puncture epidural is a novel technique which enhances the onset and adequacy of analgesia. This study will be comparison of dural puncture epidural and conventional epidural analgesia for labour analgesia.Parturients will be Randomized into two groups A and B. Pt will be kept unaware of the technique used. The same drug of same concentration will be administered to both the groups. After administration of first bolus ,the adequacy of analgesia will be assessed every 2 minutes till adequate analgesia is achieved. Analgesia is considered to be adequate if the VAS score is less than 3. First time to top up will be recorded as duration of analgesia. The incidence of hypotension and post dural puncture headache will also be noted. |