| CTRI Number |
CTRI/2019/05/019271 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
22/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Comparing 0.1% Ropivacaine and 0.0625% Bupivacaine, with fentanyl for labour pain relief" |
|
Scientific Title of Study
|
"Comparison of 0.1% Ropivacaine and 0.0625% Bupivacaine, with fentanyl as an adjuvant for labour analgesia" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Ranganaayaki |
| Designation |
Post Graduate Resident 1st year |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology
Sri Manakula Vinayagar medical college and Hospital, kalitheerthalkuppam, Madagadipet
Pondicherry 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9789709095 |
| Fax |
|
| Email |
rangaganesan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Prabu |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Department of Anaesthesiology
Sri Manakula Vinayagar medical college and Hospital, kalitheerthalkuppam, Madagadipet
Pondicherry 605107
Department of Anaesthesiology
Sri Manakula Vinayagar medical college and Hospital, kalitheerthalkuppam, Madagadipet
Pondicherry 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G Ranganaayaki |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology
Sri Manakula Vinayagar medical college and Hospital, kalitheerthalkuppam, Madagadipet
Pondicherry 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9789709095 |
| Fax |
|
| Email |
rangaganesan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Sri Manakula Vinayagar medical college and Hospital, kalitheerthalkuppam, Madagadipet
Pondicherry |
|
|
Primary Sponsor
|
| Name |
G Ranganaayaki |
| Address |
Department of Anaesthesiology
Sri Manakula Vinayagar medical college and Hospital, kalitheerthalkuppam, Madagadipet
Pondicherry |
| Type of Sponsor |
Other [Self sourcing] |
|
|
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 |
| G Ranganaayaki |
Sri ManakulaVinayagar Medical College and Hospital |
OG OT complex
Department of Anaesthesiology
Sri Manakula Vinayagar medical college and Hospital, kalitheerthalkuppam, Madagadipet
Pondicherry
PONDICHERRY |
9789709095
rangaganesan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.0625% Bupivacaine |
0.0625% Bupivacaine with 2 micrograms/ml fentanyl as an adjuvant for epidural labour analgesia. Loading dose 10ml given after cervical dilatation of 4cm. Epidural top up given with ml after assessing visual analogue scale |
| Intervention |
0.1% of Ropivacaine |
0.1% of Ropivacaine with 2 micrograms/ml fentanyl as an adjuvant for epidural labour analgesia. Loading dose of 10ml after 4cm of cervical dilatation. Epidural top up given with 5ml after assessing visual analogue scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Parturients requesting epidural analgesia in SMVMCH from May 2019 to September 2020
2. Parturients of ASA physical status 1 and 2
3.Parturients in active labour with cervical dilation of more than 3 cm
4. Full term live fetus without any obstetric complication |
|
| ExclusionCriteria |
| Details |
1) Height < 150cm
2) BMI >30
3) Age <18 years
4) Anticipated difficult intubation
5) Contraindications for epidural catheter placement
6) Hyper-sensitivity to study drugs.
7) Administration of IV analgesics within 1hr of epidural request
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief |
Visual analog scale score will be recorded every 5 min for first 30 min, then at every 30 min till the end of labor. VAS at the end of the first stage and second stage is also noted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
maternal sedation
sensory blockade
motor blockade |
Maternal sedation will be assessed using modified Ramsay sedation score. Motor block will be assessed by Bromage scale and peak motor block achieved during study is noted. Sensory block will be assessed by loss of cold sensation in midclavicular line, every 30 min and peak sensory level achieved during the study will be noted down. Fetal heart rate will be recorded throughout the study; neonatal welfare will be assessed by Apgar score. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
23/05/2019 |
| 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 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
|
With the help of this study, we would like to identify the drug which is safe and long acting with less adverse effects to be used as a labour analgesia. I would like to implicate findings of this study so as to provide adequate analgesia during labour. We would like to compare between 0.1% Ropivacaine and 0.0625% Bupivacaine in releiving labour pain with less or no adverse effects, duration of action of each drug. |