| CTRI Number |
CTRI/2024/07/070752 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Epidural labour analgesia- comparison between fentanyl and dexamethasone as adjuvant |
|
Scientific Title of Study
|
Comparison of epidural dexamethasone-ropivacaine and fentanyl-ropivacaine for ambulatory labour analgesia- A triple blind prospective randomized 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 Asma Anjum |
| Designation |
Junior resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College, Kangra at Tanda, H.P |
| Address |
2nd floor,Department of Anaesthesiology, Dr RPGMC Tanda at kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8010399995 |
| Fax |
|
| Email |
asma.anjum96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Gupta |
| Designation |
Associate Professor |
| Affiliation |
Dr rajendra prasad government medical college, kangra at tanda |
| Address |
2nd floor, Department of Anaesthesiology, Dr Rajendra Prasad Government medical college, kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418044928 |
| Fax |
|
| Email |
drbharti203@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asma Anjum |
| Designation |
Junior resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College, Kangra at Tanda, H.P |
| Address |
2nd floor, Department of Anaesthesiology, Dr RPGMC, Tanda at Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8010399995 |
| Fax |
|
| Email |
asma.anjum96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr RPGMC, Tanda at Kangra, Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 Asma Anjum |
Dr RPGMC, Tanda at Kangra, Himachal pradesh |
2nd floor, Department of Anaesthesiology
Kangra
HIMACHAL PRADESH |
8010399995
asma.anjum96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Dr Rajendra Prasad Government medical college, kangra at tanda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural labour analgesia |
COMPARING EFFECT OF TWO DRUG
COMBINATION FOR
AMBULATORY LABOUR
ANALGESIA |
| Comparator Agent |
Ropivacaine +fentanyl v/s Ropivacaine + dexamethasone |
Comparison between the effects of drug combination in each group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy with cephalic presentation in established labor with contractions that occur at regular intervals and become stronger with passage of time (NICE guidelines).
Term pregnancy with POG ranging from 37-41 weeks
Reassuring cardiotocographic finding
Patients requesting for ambulatory labor analgesia
|
|
| ExclusionCriteria |
| Details |
Patient refusal for the procedure.
Local infection at site of epidural catheter placement.
Thrombocytopenia.
Coagulopathies.
HELLP syndrome.
PROM
Sepsis.
Deafness.
Spinal column deformities and spine surgery.
Patient having hypersensitivity to the study drug.
In case of Intrathecal catheter placement.
In case of accidental dural puncture.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the total amount of ropivacaine when used with dexamethasone in one group and when used with fentanyl in the other group in laboring parturients with ambulatory epidural labor analgesia |
To check the vitals, drug consumption, ambulation at 0 minute, 15 minutes,30 minutes and then every hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
blood pressure, heart rate, respiratory rate, oxygen saturation throughout the obstetrical variables including duration of labour, mode of delivery, intrapartum & postpartum complications.
duration of ambulation in both groups.
perinatal outcome including live birth/still birth, APGAR score at 1 & 5 mins, & NICU admissions
effect of ambulation on duration of first & second stage of labour.
incidence of maternal fever in both groups upto 12 hrs .
incidence of maternal hyperglycemia in both groups upto 12 hrs.
patients’ satisfaction.
Obstetrician satisfaction
|
0 MIN
5 MIN
15MIN
EVERY 15 MIN TILL ONE HOUR
EVERY 30 MIN UNTIL DELIVERY |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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 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
|
Continuous research for balanced labour analgesia that provides relief
from pain while prserving motor functions has lead to development of
ambulatory labour analgesia techniques. Ambulatory labour analgesia is a
popular choice for labour analgesia because ambulation reportedly
incrteases increases maternal comfort, increases the intensity of uterine
contractions and eventually shorten labour. Various studies have
concluded that epidural tramadol is a safe and effective method for
labour pain relief better than iv tramadol. Studies that compare different
combinations of epidural drug delivery for ambulatory labour analgesia
from indian clinical scenario are few. thus, we are planning to study
effect of intermittent bolus of ropivacaine 0.1% with comination of
fentanyl 2 microgram/ml and ropivacaine 0.1% with combination of tramadol
2mg/ml in parturients with ambulatory labour analgesia.
|