| CTRI Number |
CTRI/2022/12/048591 [Registered on: 29/12/2022] Trial Registered Prospectively |
| Last Modified On: |
28/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF THREE TECHNIQUE FOR LABOUR PAIN RELIEF |
|
Scientific Title of Study
|
COMPARISON OF EPIDURAL, COMBINED SPINAL EPIDURAL AND DURAL PUNCTURE EPIDURAL TECHNIQUES 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 Ranjana Khetarpal |
| Designation |
Professor |
| Affiliation |
GMC , AMRITSAR |
| Address |
Room - Anesthesia professor office
Department of anesthesia and critical care
GMC,AMRITSAR.
Room - Department of anesthesia and critical care office
GMC,AMRITSAR.
Amritsar
PUNJAB
143001
India |
| Phone |
9815654332 |
| Fax |
|
| Email |
rkhetarpal9@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjana Khetarpal |
| Designation |
Professor |
| Affiliation |
GMC , AMRITSAR |
| Address |
Room - Anesthesia professor office
Department of anesthesia and critical care
GMC,AMRITSAR.
Room - Department of anesthesia and critical care
GMC,AMRITSAR.
Amritsar
PUNJAB
143001
India |
| Phone |
9815654332 |
| Fax |
|
| Email |
rkhetarpal9@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjana Khetarpal |
| Designation |
Professor |
| Affiliation |
GMC , AMRITSAR |
| Address |
Room - Anesthesia professor office
Department of anesthesia and critical care
GMC,AMRITSAR.
Room - Anesthesia professor office
Department of anesthesia and critical care
GMC,AMRITSAR.
PUNJAB
143001
India |
| Phone |
9815654332 |
| Fax |
|
| Email |
rkhetarpal9@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ranjana khetarpal
Anesthesia Department, GMC , Amritsar. |
| Dr Veena Chatrath
Anesthesia Department, GMC , Amritsar. |
|
|
Primary Sponsor
|
| Name |
Government Medical College Amritsar |
| Address |
circular road,AMRITSAR. |
| 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 Aishwarya Madaan |
GYNAE OT, BEBE NANKI HOSPITAL |
ROOM -GYNAE OT
BEBE NANKI HOSPITAL, MAJITHA ROAD.
GMC AMRITSAR
Amritsar
PUNJAB |
09569794261
aishwarya.madaan.md@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 |
ASA GRADE 1 AND 2 WERE SELECTED |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMPARISON OF EPIDURAL, COMBINED SPINAL EPIDURAL AND DURAL PUNCTURE EPIDURAL TECHNIQUES FOR LABOR ANALGESIA |
LABOUR ANALGESIA IN EPIDURAL ( 0.125% isobaric levobupivacaine along with 30µg fentanyl ) VS COMBINED SPINAL EPIDURAL (1.2ml of 0.25% isobaric levobupivacaine with 25µg fentanyl for sub–arachnoid block followed by epidural top-ups of 15ml of 0.125% levobupivacaine with 30µg fentanyl) VS DURAL PUNCTURE EPIDURAL (0.125% isobaric levobupivacaine along with 30µg fentanyl in the epidural top-up) |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women with Singleton pregnancy, at term, cephalic
presentation and in active stage of labour, with full term live fetus.
2. Primigravida (without any obstetric complications) requesting labour
analgesia
3. ASA Physical Status 1 and 2
4. Having regular contractions at least once every 5 minutes
5. Parturient belonging to age group 20-35years
6. Height> 145cm
7. BMI 18-25(weight/height2)
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patient with gestational hypertension, preeclampsia, gestational
diabetes mellitus
3. Any contraindication for neuraxial procedures
4. Cephalopelvic disproportion
5. Coagulation disorders and bleeding disorder
6. Hypersensitivity to the drug under study
7. Any spine deformity
8. Any obstetric complications
9. History of any drug abuse
10. History of any cardiac arrhythmias or labile hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Aims:-
• Onset of sensory & motor block
• Duration of sensory and motor block
Quality of analgesia
|
All these parameters are recorded at 2 minutes interval for first 10 minutes, at 5 minute interval from 10 to 30 minutes and at 15 minutes interval from 30 minutes to 300 minutes or until the end of delivery, whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Aims:-
• Maternal Hemodynamic
• Maternal satisfaction score
• Side effects and complications
• Surgeon satisfaction score
 
|
All hemodynamic parameters were recorded at 2 minutes interval for first 10 minutes, at 5 minute interval from 10 to 30 minutes and at 15 minutes interval from 30 minutes to 300 minutes or until the end of delivery, whichever was earlier.
Maternal satisfaction score was calculated 24 hours after the 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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/12/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Various method of labour analgesia are now available which are safe and
effective; beneficial to both the mother and the fetus. Lumbar epidural has been
the mainstay since many years. Combined Spinal Epidural analgesia has
emerged as newer and safe alternative technique. A recent technique of Dural
Puncture Epidural is now a days becoming popular. The aim of the present
study is to compare Epidural, Combined Spinal Epidural and Dural Puncture
Epidural techniques for labour analgesia using levobupivacaine along with
fentanyl as adjuvant. Aim will be accomplished by carrying out a study in 60
parturients of ASA grade 1 and 2 in age group of 20-35 years. The parturients
will be randomly divided into 3 groups of 20 each. Group E (Epidural Group)
will receive 15ml of 0.125% isobaric Levobupivacaine with 30µg fentanyl in the
epidural space. Group CSE (Combined Spinal Epidural group) will receive
1.2ml (3mg) of intrathecal 0.25% isobaric Levobupivacaine with 25µg fentanyl
and epidural top up of 15ml of 0.125% Levobupivacaine with 30µg fentanyl.
Group DPE (Dural Puncture Epidural group) will receive 15ml of 0.125%
isobaric Levobupivacaine with 30µg fentanyl in epidural space while intrathecal
medication will be withheld. Epidural top up dose will be given according to
assessment of pain while Visual Analogue Scale (VAS). All the vitals will be
monitored till the end of delivery. Analgesic efficacy extent of sensory and motor
block, maternal and fetal outcome, duration of analgesia and maternal
satisfaction score will be compared and analyzed statistically. |