| CTRI Number |
CTRI/2018/01/011236 [Registered on: 10/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does local anaesthetic drug 0.08% levobupivacaine reduce the rate of instrumental vaginal delivery compared to another local anaesthetic drug 0.1% ropivacaine |
|
Scientific Title of Study
|
Comparison of Epidural Boluses of 0.08%
Levobupivacaine and 0.1% Ropivacaine
Using 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 |
Surya R |
| Designation |
Postgraduate ( MD Anaestheiology) |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
08489177972 |
| Fax |
|
| Email |
dr.anniej@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Annie Sheeba J |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9655035791 |
| Fax |
|
| Email |
annie.john24@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Annie Sheeba J |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College and research institute
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9655035791 |
| Fax |
|
| Email |
annie.john24@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute
Department of Anaesthesiology
Pillayarkuppam
Pondicherry |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College and Research Institute
Pillayarkuppam
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 |
| surya R |
Mahatma Gandhi Medical College and Research Institute |
Department of Anaesthesiology
Mahatma Gandhi Medical College
Pillayarkuppam
Pondicherry
PONDICHERRY |
08489177972
dr.anniej@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional human ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pregnant patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.08% levobupivacaine with fentanyl |
epidural catheter is inserted in patients with labour pain and analgesia is given by injecting 0.08% levobupivacaine with fentanyl via epidural catheter |
| Comparator Agent |
0.1% ropivacaine with fentanyl |
epidural catheter is inserted in patients with labour pain and analgesia is given by injected 0.1% ropivacaine with fentanyl via epidural catheter |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1) Primigravida with singleton pregnancy
2) Willing to involve in this study
3) Age between 18years to 30years.
4) Categorized under ASA PS I & II |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)High risk pregnancy
3)Primigravida with CPD
4)With fetal anomaly
5)Allergic to local anaesthetics
6)Injection site infection
7)Spine abnormalities
8)Significant coagulopathies. |
|
|
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 |
Mode of delivery
|
time of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic ( SpO2, MAP, PR, FHR)
2. Foetal outcome
3. Maternal satisfaction
4. Side-effects. |
1. every 10 minutes from initiation analgesia to delivery
2. 1 minute and 5 minute after baby delivery
3. 1 hour after baby delivery
4.from the initiation of analgesia to delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2015 |
| Date of Study Completion (India) |
10/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
no publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study was aimed to assess the efficacy of two local anaesthetic agents ( levibupivacaine and ropivacaine) for labour analgesia. We aimed to assess the mode of delivery, analegesia score, patient satisfaction score and complications, if any. it is a double blinded study and randomization was done by computer generated number, ealed envelope technique. epidural catheter was placed at the first stage of labour and epidural activated with the repective study drug. patient was monitored for analgesia, motor blockade and hemodynamics. study ended with delivery of baby. Results Mode Of Delivery: In Levobupivacaine (n=35),
4 parturients underwent Cesarian section (11.4%) and in Ropivacaine group
(n=35), 13 underwent Cesarian section (37.1%) which was statistically
significant (p=0.012)
Instrumentation Among Vaginal Delivery : In Levobupivacaine Group, out of the 31
Vaginal deliveries, two had Instrumentation (6.45%). In Ropivacaine group, out
of the 22 Vaginal deliveries, one underwent Instrumentation (4.54%) which was
statistically not significant (p=0.739)
Hemodynamics , baby apgar, maternal
satisfaction were comparable in both groups with no side effects |