| CTRI Number |
CTRI/2023/03/050818 [Registered on: 17/03/2023] Trial Registered Prospectively |
| Last Modified On: |
16/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between intermittent epidural bolus and continuous epidural infusion for labor analgesia. A randomized double blinded study |
|
Scientific Title of Study
|
A comparision between Intermittent Epidural bolus and Continuous Epidural infusion for labor analgesia. Using Levobupivacaine and Fentanyl-A randomized two arm study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Napolean K |
| Designation |
1st year PostGraduate |
| Affiliation |
Aarupadai veedu medical college |
| Address |
A block 1st floor Department of Anesthesiology
Aarupadai veedu medical college Kirumampakkam Pondicherry
A block 1st floor Department of Anesthesiology
Aarupadai veedu medical college Kirumampakkam Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8056458382 |
| Fax |
|
| Email |
nephs007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjith kumar |
| Designation |
Associate professor |
| Affiliation |
Aarupadai veedu medical college |
| Address |
A block 1st floor Department of Anesthesiology Aarupadai veedu medical college Kirumampakkam Pondicherry
A block 1st floor Department of Anesthesiology
Aarupadai veedu medical college Kirumampakkam Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8056289625 |
| Fax |
|
| Email |
Ranjit9124@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjith kumar |
| Designation |
Associate professor |
| Affiliation |
Aarupadai veedu medical college |
| Address |
A block 1st floor Department of Anesthesiology Aarupadai veedu medical college Kirumampakkam Pondicherry
A block 1st floor Department of Anesthesiology
Aarupadai veedu medical college Kirumampakkam Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8056289625 |
| Fax |
|
| Email |
Ranjit9124@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college Hospital |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college and Hospital |
| Address |
Department of Anesthesiology
Aarupadai veedu medical college and Hospital Kirumampakkam Puducherry Pondicherry |
| Type of Sponsor |
Private 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 |
| Napolean K |
Aarupadai veedu medical college and Hospital |
Department of Anaesthesiology
Aarupadai veedu medical college and Hospital kirumampakkam puducherry
Pondicherry
PONDICHERRY |
8056458382
nephs007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC Human ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.0625% levobupivacaine and fentanyl 0.5mcg per ml fentanyl in continuous epidural infusion and intermittent epidural bolus for pain free labor |
One group will receive levobupivacaine and fentanyl as continuous infusion and other group will receive theses drugs as intermittent bolus through epidural |
| Intervention |
Continuous epidural infusion vs intermittent epidural bolus with levobupivacaine and fentanyl for labor analgesia |
Patients from both group will receive 0,0625% levobupivacaine and 1mcg per ml fentanyl as a loading dose and then One group will receive 0.0625% levobupivacaine and 0.5mcg per ml of fentanyl 10ml every hour begins 60 mins after loading dose and another group will receive 0.0625% levobupivacaine and 0.5mcg per ml fentanyl at a rate of 10ml per hour begins immediately after loading dose. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and ASA 2
Primigravida
Cervical dilatation <4 cm |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with Pregnancy induced Hypertension,Heart disease and Anemia
Cervical dilatation >4cm
Breech and multiparous women
Coagulopathy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare total analgesic consumption between continuous epidural infusion and Intermittent epidural bolus group |
Every one hour after loading dose till the end of the labor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare motor blockade and mode of delivery between continuous and intermittent epidural analgesia |
12 hours - 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
27/03/2023 |
| 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="8"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The summary of the study is to provide pain free labor and also to prove that Intermittent Epidural bolus is better than Continuous Epidural infusion for labor analgesia interms of dosage consumption |