| CTRI Number |
CTRI/2018/02/011711 [Registered on: 05/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomised control trial comparing Ropivacaine, levobupivacaine and bupivacaine for spinal anaesthesia for caesarean section |
|
Scientific Title of Study
|
A randomised control trial comparing intrathecal ropivacaine, levobupivacaine and bupivacaine for caesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Sethi |
| Designation |
Associate Professor |
| Affiliation |
ESI-PGIMSR, New Delhi |
| Address |
A -2B / 118 - B
Paschim Vihar
Department of Anaesthesia
ESIC PGIMSR
Basaidarapur, Ring Road
New Delhi
West
DELHI
110063
India |
| Phone |
|
| Fax |
|
| Email |
divyasth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Sethi |
| Designation |
Associate Professor |
| Affiliation |
ESI-PGIMSR, New Delhi |
| Address |
A -2B / 118 - B
Paschim Vihar
DELHI
110063
India |
| Phone |
|
| Fax |
|
| Email |
divyasth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Sethi |
| Designation |
Associate Professor |
| Affiliation |
ESI-PGIMSR, New Delhi |
| Address |
A -2B / 118 - B
Paschim Vihar
Department of Anaesthesia, ESIC PGIMSR
2nd Floor Operation theatre Complex
Basaidarapur, Ring Road, New Delhi
West
DELHI
110063
India |
| Phone |
|
| Fax |
|
| Email |
divyasth@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI-Post graduate Institute of Medical Sciences and Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
ESICPostgraduate Institute of Medical Sciences and Research |
| Address |
Basaidarapur, Ring Road
New Delhi |
| 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 |
| Divya Sethi |
ESI-Postgraduate Institute of Medical Sciences and Research |
Basaidarapur, Ring Road
West
DELHI |
9891230700
divyasth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESI -PGIMSR Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Term Pregnant Patients with uncomplicated pregnancy scheduled to for Caesarean Section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HYPERBARIC BUPIVIVAINE FOR SPINAL ANESTHESIA |
In control group, hyperbaric bupivicaine will be used as drug for spinal anaesthesia |
| Intervention |
Isobaric levobupivacaine for spinal anaesthesia |
In the test group 1, Isobaric levobupivacaine will be used for spinal anaesthesia |
| Intervention |
Isobaric Ropivacaine for spinal anaesthesia |
In test group 2, Isobaric Ropivacaine will be used for spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Full term patients scheduled for caesarean section of ASA status1 and 2, age group of 18 to 40 years, body weight of 45 to 85 kg and height of 145 to165cm. |
|
| ExclusionCriteria |
| Details |
Parturients with hypersensitivity to local anesthetics, contraindications to neuraxial block, twin pregnancy, obstetric complications or fetal compromise were excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of motor block |
Duration of motor block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensory and Motor block onset times
Sensory and Motor block regression times
First analgesic request time
Hemodynamic Parameters
Apgar Scores
Quality of Anaesthesia and Muscle relaxation
Side-Effects |
Intra and Post operative Period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2015 |
| Date of Study Completion (India) |
16/02/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Accepted for Publication
Sethi D. Randomised Control Trial Comparing Plain Levobupivacaine and Ropivacaine with Hyperbaric Bupivacaine in Caesarean Deliveries. Turk J Anaesthesiol Reanim 2019; DOI: 10.5152/TJAR.2019.50465
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study was to evaluate the spinal block characteristic of isobaric 0.5% levobupivacaine, isobaric 0.75% ropivacaine and its comparison with hyperbaric 0.5% bupivacaine for elective caesarean section. 100 term pregnant women with singleton pregnancy scheduled for elective caesarean section will be enrolled in this prospective double blind randomised trial. Written informed consent will be taken from all patients. Subarachnoid block will be given for caesarean section with 25 g spinal needle in L3-L4 with patients in left lateral position After confirming free flow of CSF, 2ml of test drug will be injected intrathecally. Group B = 2 ml of 0.5% hyperbaric bupivacaine Group R = 2 ml or 0.75 % isobaric ropivacaine Group LB = 2 ml of 0.5 % isobaric levobupicaine The following variables will be measured during intraoperatively: Sensory block and block onset times: modified bromage scale, Maximum sensory and motor block level achieved, Maternal Hemodynamic parameters ( 5 min interval), Neonatal Apgar Scores ( 1 and 5 mins), Quality of Anaesthesia (at the end of surgery), Quality of muscle relaxation, Sensory and motor block regression times, First analgesic request time, Side effects if any. Patients will be followed up on post-operative days 1 and 3 for any headache, backache, tingling or numbness in lower limbs. |