| CTRI Number |
CTRI/2017/08/009542 [Registered on: 29/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the minimum effective dose of epidural levobupivacaine with fentanyl for pain relief in labour after combined spinal epidural labour analgesia |
|
Scientific Title of Study
|
To evaluate and compare epidural minimum local analgesic concentration of levobupivacaine with fentanyl in patients receiving intrathecal fentanyl with and without levobupivacaine for labour analgesia |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr L H Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Dr L H Hiranandani Hospital,
Hillside Avenue,
Hiranandani Gardens,
Powai, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr L H Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Dr L H Hiranandani Hospital,
Hillside Avenue,
Hiranandani Gardens,
Powai, Mumbai
Department of Anaesthesia,
Dr L H Hiranandani Hospital,
Hillside Avenue,
Hiranandani Gardens,
Powai, Mumbai
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Hema Solanki |
| Designation |
Resident Anaesthesiologist |
| Affiliation |
Dr L H Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Dr L H Hiranandani Hospital,
Hillside Avenue,
Hiranandani Gardens,
Powai, Mumbai
Same as above
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9820122203 |
| Fax |
|
| Email |
drhema.29s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr L H Hiranandani Hospital |
|
|
Primary Sponsor
|
| Name |
Dr L H Hiranandani Hospital |
| Address |
Dr L H Hiranandani Hospital,
Hillside Avenue,
Hiranandani Gardens,
Powai, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Meenoti Potdar |
Dr L H Hiranadani Hospital |
Labour room
Department of Obstetrics and Gynaecology
Hillside Avenue
Hiranandani Gardens
Powai Mumbai-400076
Mumbai (Suburban)
MAHARASHTRA |
9920627839
meenoti@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr L H Hiranandani Hospital Powai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Primigravida women requesting labour analgesia with full term gestation 36-40 weeks, singleton pregnancy with cephalic presentation having American Society Of Anesthesiologists physical status II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal fentanyl 25 mcg |
Minimum epidural local analgesic concentration of levobupivacaine and fentanyl after intrathecal fentanyl started after intrathecal analgesia till baby delivery |
| Intervention |
Intrathecal levobupivacaine 2.5mg and fentanyl25mcg |
Minimum epidural local analgesic concentration of levobupivacaine and fentanyl after intrathecal levobupivacaine and fentanyl started after intrathecal analgesia till baby delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Primigravida women requesting labour analgesia with full term gestation 36-40 weeks, singleton pregnancy with cephalic presentation having American Society Of Anesthesiologists physical status II
2.Patients giving valid informed consent.
3.Patients in active stage of induced labour with cervical dilatation of 4-5 cm at the time of epidural catheter placement
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Gestational age >36 weeks with malpresentation/ multiple gestation.
3. Patients with PIH / Eclampsia.
4. Patients who have received IV/ IM opioids within 4 hours of epidural insertion.
5. Entered in second stage of labour.
6. Delivery within 30mins of intrathecal analgesia.
7. Delivery without the requirement of epidural top up.
8. Failure to obtain VAS<2 after 15minutes of intrathecal drug injection.
9. Patient with motor block higher than T4 dermatomal level at any time post procedure suspecting intrathecal epidural catheter insertion.
10. Inadvertent dural puncture during epidural space localization.
11. Patients with contraindication to regional analgesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare epidural minimum local analgesic concentration of levobupivacaine with fentanyl in patients receiving intrathecal fentanyl with and without levobupivacaine for labour analgesia |
During labour analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of intrathecal analgesia
quality of analgesia
haemodynamic monitoring
maternal and neonatal outcome |
During labour analgesia |
|
|
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)
|
24/08/2016 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is conducted to evaluate and compare the minimum local analgesia concentration ( MLAC) of epidural levobupivacaine with fentanyl in patients receiving combined spinal epidural labour analgesia with intrathecal fentanyl with and without levobupivacine. We have included primigravida with full term pregnancy with cephalic presentation in active induced labour. We would like to evaluate whether addition of levobupivacaine intrathecally with fentanyl has an synergistic effect on reducing the MLAC of levobupivacaine with fentanyl epidurally and does it affect the course, quality of analgesia and maternal and fetal outcome of labour. |