CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2020/01/022915 [Registered on: 22/01/2020] Trial Registered Prospectively

Last Modified On:

07/01/2020

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison between hourly intermittent Epidural bolus and continuous epidural infusion of 0.1% Levobupivacaine AND Fentanyl for analgesia in labor.

Scientific Title of Study

Comparison between intermittent Epidural bolus and continuous Epidural infusion of 0.1% levobupivacaine and fentanyl combination for labor analgesia.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Surinder kaur
Designation	Junior Resident
Affiliation	Government Medical College and Rajindra hospital
Address	Department of Anaesthesia Government Medical College and Rajindra hospital, Patiala Patiala PUNJAB 144202 India
Phone	9915176132
Fax
Email	dr_surinder18@yahoo.com

Details of Contact Person
Scientific Query

Name	Dr Tripat Kaur Bindra
Designation	Professor
Affiliation	Government Medical College and Rajindra hospital
Address	Department of Anaesthesia Government Medical College and Rajindra hospital, Patiala. Patiala PUNJAB 147001 India
Phone	9501017040
Fax
Email	tripat_noori@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Tripat Kaur Bindra
Designation	Professor
Affiliation	Government Medical College and Rajindra hospital
Address	Department of Anaesthesia Government Medical College and Rajindra hospital, Patiala Patiala PUNJAB 147001 India
Phone	9501017040
Fax
Email	tripat_noori@yahoo.co.in

Source of Monetary or Material Support

Government medical college and rajindra hospital,Patiala(Punjab)

Primary Sponsor

Name	Department of anaesthesiology and intensive care
Address	Government college and rajindra hospital ,patiala
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Surinder kaur	Government Medical college and Rajindra hospital	Department of Anaesthesia and intensive care, Government medical college and Rajindra hospital,Patiala Patiala PUNJAB	9915176132 dr_surinder18@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Government Medical college,Patiala	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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 labor analgesia	Intermittent epidural bolus an hourly versus continuous epidural infusion of 0.1% levobupivacaine and fentanyl 2 mcg/ml combination for labor analgesia till the time of delivery of the baby.
Comparator Agent	not applicable	not applicable

Inclusion Criteria

Age From	20.00 Year(s)
Age To	45.00 Year(s)
Gender	Female
Details	parturient with single pregnancy. Cervical dilatation of 3-5 cm. Cephalic presentation Gestation >37 weeks

ExclusionCriteria

Details

Breech presentation
Antepartum Haemorrhage
Severe Pre eclampsia
Multiple pegnancies
Cephalopelvic disproportion
Bleeding disorders
Decreased platelet counts
Sepsis
Aortic stenosis
Diabetes
Fetal distress
Imminent delivery
spinal column deformity
Spine surgery
Contraindication to epidural analgesia
History of anaphylaxis to local anaeshetics and allergy to drug to be administered.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Level of analgesia	Till the time of delivery of the baby.

Secondary Outcome

Outcome	TimePoints
Total drug requirement ,Mode of delivery, Postpartum complications	48 hours after delivery.

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
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)

27/01/2020

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)

Not Yet Recruiting

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

The present randomized study will be conducted on 80 women in labour, belonging to ASA grade I or II, more than 36 weeks of gestation, at 3- 5 cm cervical dilatation, single pregnancy with cephalic presentation, who requested for labour analgesia at Rajindra Hospital, Patiala. The patients will be allocated randomly to 2 groups. Group A: Parturient will be given 10 ml of 0.1% Levobupivacaine (plain ) with Fentanyl 50 mcg and then 8 ml of 0.1% Levobupivacaine (plain ) and fentanyl 2 mcg / ml solution as epidural bolus every hour. Group B: Parturient will be given 10 ml of 0.1% levobupivacaine (plain ) with fentanyl 50 mcg and then 8 ml /hour of 0.1% Levobupivacaine (plain ) with fentanyl 2 mcg / ml as continuous epidural infusion. After administration of the drug,pain intensity, level of sensory block, degree of motor block, total drug requirement ,hemodynamic variables, mode of delivery, duration of second stage,neonatal outcome and side effects and post partum complications will be compared in both the groups.