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CTRI Number  CTRI/2014/12/005335 [Registered on: 30/12/2014] Trial Registered Retrospectively
Last Modified On: 13/12/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare efficacy of two drugs, Bupivacaine hydrochloride & Ropivacaine hydrochloride for extradural labour analgesia.  
Scientific Title of Study   A Double blind comparison of combination of 0.1% Ropivacaine & Fentanyl to combination of 0.1% Bupivacaine & Fentanyl for extradural analgesia in labour. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KISHORI BAWDANE 
Designation  Assistant professor . 
Affiliation  Lokmanya Tilak Municipal Medical college and general hospital 
Address  1105 11th floor Sai orchid Rawal pada near N G park Dahisar east Mumbai
1105 11th floor Sai orchid Rawal pada near N G park Dahisar east Mumbai
Mumbai
MAHARASHTRA
400068
India 
Phone  9833677290  
Fax  02224031202  
Email  kishabaw@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti Magar 
Designation  Associate Professor 
Affiliation  Lokmanya Tilak Municipal Medical college and general hospital 
Address  Guide Associate Professor Dr Jyoti Magar 605,Surbahar Lokpuram hsg society, Lokpuram complex ,off Pokharan Road II,opposite Hiranandani Meadows,Pawarnagar,Thane,400601.
Guide DR Jyoti Magar Associate Professor Department of Anaesthesia College buidling 4th floor Lokmanya Tilak Municipal Medical college and general hospital Sion west Mumbai 400022
Mumbai
MAHARASHTRA
400601
India 
Phone  9833706466  
Fax  02224031202  
Email  Jyotimagr@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  KISHORI BAWDANE 
Designation  Assistant professor . 
Affiliation  Lokmanya Tilak Municipal Medical college and general hospital 
Address  Student Assistant Professor Dr kishori Bawdane 1105 11th floor A wing Sai orchid Rawal pada near N G park Dahisar east Mumbai 400068
Guide Associate Professor Dr Jyoti Magar Department of Anaesthesia 4th floor College building Lokmanya Tilak Municipal Medical college and general hospital Sion west Mumbai 400022
Mumbai
MAHARASHTRA
400068
India 
Phone  9833677290  
Fax  02224031202  
Email  kishabaw@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical college and general hospital Sion Mumbai 400022. 
 
Primary Sponsor  
Name  Lokmanya tilak municipal medical college and general hospital  
Address  Department of Anaesthesia Lokmanya tilak municipal medical college and general hospital Sion Mumbai 400022 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kishori Bawdane  Lokmanya Tilak Munipal general hospital Ward 12 labour ward under department of Anaesthesia   Lokmanya Tilak municipal medical college and general hospital Sion Mumbai 400022
Mumbai
MAHARASHTRA 		 9833677290
02224031202
kishabaw@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital staff and research society (estd.1967) Bombay Public Trust Act Reg.no.F/1669 of 21-9-1968.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Labour pain in ASA grade I and II parturients  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine hydrochloride 0.1%   Bupivacaine hydrochloride 0.1% with Fentanyl 2ug/cc for extradural labour analgesia in intermittent top up. Initial 10 ml dose then 5 ml top up till VAS score less than 4.Then 5 ml top up whenever VAS score more than 3  
Intervention  Epiduarl labour analgesia.  Epidural catheter was inserted under strict aseptic precautions when cervical dilatation reached more than 3 cm with active labour The procedure was performed using 18 G Touhy‘s needle with parturient in sitting position An 18 G multiorifice catheter with micro bacterial filter was placed in L3- L4 or L4-L5 inter vertebral space using loss of resistance technique & advancing the catheter tip 4cm cephald. The parturient was placed in supine position with left uterine displacement. 
Comparator Agent  Ropivacaine hydrochloride 0.1%   Ropivacaine hydrochloride 0.1% with Fentanyl 2ug/cc for extradural labour analgesia in intermittent top up. Initial 10 ml dose then 5 ml top up till VAS score less than 4 Then 5ml top up whenever VAS score is more than 3 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. ASA grade I and II parturients
2. Consent for project
3. More than 36 weeks of gestation
4. Single live term fetus with vertex presentation
5. Uncomplicated active labour with cervical dilatation ≥ 3 cm
 
 
ExclusionCriteria 
Details  1. Unwilling mother
2. ASA > II
3. B.M.I. more than 30
4. Parturient‘s height < 150cm
5. Age <18 years
6. Difficult intubation
7. Contraindication for epidural catheter placement
8. Complicated obstetric history
9. Sensitivity to study drug
10. Administration of IV analgesics within 1 hr of epidural request


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain relief on Visual analogue score 0 to 10
Motor block assesed by Bromage score
Dose requirement of Bupivacaine and Ropivacaine and Fentanyl
Incidence of Instrumental deliveries. 		 Pain score (VAS)and Motor block and requirement of drugs all at the begining of labour and during labour and at the end of labour
Instrumental deliveries at the end of labour.  
 
Secondary Outcome  
Outcome  TimePoints 
Maternal Haemodynamic stability
Neonatal outcome assessed by Virginia Apgar score
Duration of labour
onset of analgesia
Incidence of side effects
cost effectiveness

 		 At the begining of labour and during labour and at the end of labour. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/12/2009 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a randomized double blind parallel group study comparing the efficacy of 0.1% Bupivacaine hydrochloride with fentanyl and 0.1% Ropivacaine hydrochloride with fentanyl in extradural labour analgesia using intermittent top up doses, in 60 ASA grade I and II labouring parturients ,conducted in India.The primary outcome measures are quality of analgesia assesd by VAS score,incidence of motor  blockade assessed by bromage score ,sensory block,requirement of Bupivacaine and Ropivacaine and Fentanyl,obstetric interventions. Secondary  outcome measures are maternal haemodynamic stability,duration of labour,onset of analgesia,incidense of side effects,cost effectiveness.

 
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