| CTRI Number |
CTRI/2025/04/085896 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial to check if breathing techniques helps pain killing effects of epidural analgesia or not |
|
Scientific Title of Study
|
Comparative Study of epidural analgesia using ropivacaine and fentanyl VS epidural analgesia using ropivacaine and fentanyl with Breathing Technique during Labour |
| 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 shivangi Patel |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
Room no 310, Department of Anaesthesia Third floor, GMERS medical college junagadh, majewadi gate, junagadh.
Junagadh
GUJARAT
362001
India |
| Phone |
919408575739 |
| Fax |
|
| Email |
shivangipatel133@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shivangi Patel |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
Room no 310, Department of Anaesthesia,Third floor, GMERS medical college junagadh, majewadi gate, junagadh.
Junagadh
GUJARAT
362001
India |
| Phone |
919408575739 |
| Fax |
|
| Email |
shivangipatel133@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shivangi Patel |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
Room no 310, Department of Anaesthesia Third floor, GMERS medical college junagadh, majewadi gate, junagadh.
Junagadh
GUJARAT
362001
India |
| Phone |
919408575739 |
| Fax |
|
| Email |
shivangipatel133@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS medical college junagadh |
|
|
Primary Sponsor
|
| Name |
Dr Shivangi Patel |
| Address |
310, third floor, GMERS medical college junagadh |
| Type of Sponsor |
Other [self] |
|
|
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 Shivangi Patel |
GMERS medical college and hospital junagadh |
407, fourth floor, GMERS medical college junagadh.
Junagadh
GUJARAT |
94085 75739
shivangipatel133@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, GMERS Medical College,Junagadh. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breathing techniques |
This group will receive epidural analgesia using a combination of 12ml of Ropivacaine 0.125% and Fentanyl 25mcg along with Lamaze breathing technique. |
| Comparator Agent |
conventional epidural analgesia |
This group will receive epidural analgesia using a combination of 12ml of Ropivacaine 0.125% and Fentanyl 25mcg. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
single pregnancy
cephalic position
primi gravida
37-42 weeks of pregnancy |
|
| ExclusionCriteria |
| Details |
contraindications to epidural analgesia
maternal complications of pregnancy
maternal medical condition
allergy yo local anaesthetic agent
inability to communicate
refusal of epidural analgesia
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of epidural analgesia alone versus epidural analgesia combined with breathing techniques in reducing pain intensity during active labor, as assessed by Visual Analog Scale |
at 15 minutes, 30 minutes 1 hour and every hourly till delivery happens. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess maternal satisfaction with pain relief & overall childbirth experience between the two groups |
maternal mean arterial pressure & heart rate at 15 minutes, 30 minutes 1 hour & then every hourly till delivery happens |
| comparison of neonatal apgar score between both the groups |
Apgar score at 1 and 5 minutes |
| to assess the number of top up dose needed in both the groups |
this observation dose not need time frame as it counts number of doses given till startpoint till delivery of child happens |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/05/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Epidural analgesia fulfills the objective of decreasing the pains of Labor without affecting other sensations such as a desire to push and to allow normal walking while preserving the tone of pelvic floor muscles as well as retaining the sensation of the baby’s head in the vagina; thus, allowing labor to proceed unhindered. Adding opioids improves the analgesic quality and reduces the side effects as it allows reduction of the concentration of the local anesthetic.
Non-Pharmacological methods to relieve pain are effective, affordable, accessible and less hazardous. Therefore, we used breathing technique on pain intensity, physiological response to labor pain, labor type and the outcomes. |