FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/09/003968 [Registered on: 11/09/2013] Trial Registered Retrospectively
Last Modified On: 28/01/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess the effect of intravenous paracetamol on reduction of hourly average consumption of epidural levobupivacaine and fentanyl mixture in labouring parturients 
Scientific Title of Study   Intravenous paracetamol as an adjunct to patient-controlled epidural analgesia with levobupivacaine and fentanyl in labour: a randomized controlled study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanika Gupta 
Designation  Junior Resident 
Affiliation  Government medical college and hospital  
Address  Deptt of Anaestheia and Intensive care Government medical college and hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  9646060628  
Fax    
Email  guptakanika.hp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Sukanya Mitra 
Designation  Professor 
Affiliation  Government medical college and hospital 
Address  Deptt of Anaestheia and Intensive care Government medical college and hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121521  
Fax  91-172-2609360  
Email  drsmitra12@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof Sukanya Mitra 
Designation  Professor 
Affiliation  Government medical college and hospital 
Address  Deptt of Anaestheia and Intensive care Government medical college and hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121521  
Fax  91-172-2609360  
Email  drsmitra12@yahoo.com  
 
Source of Monetary or Material Support  
Government medical college and hospital Sector 32 Chandigarh 
 
Primary Sponsor  
Name  Department of anaesthesia and intensive care 
Address  Government medical college and hospital Sector 32 Chandigarh 
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 
Dr Kanika Gupta  Department of Anaesthesia and intensive care  Level 5 , D block Government Medical college and hospital Sector 32
Chandigarh
CHANDIGARH 		 9646060628

guptakanika.hp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethical committee. Government medical college and hospital sector 32 Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pregnant Parturient ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  intavenous saline ioo ml as placebo followed by epidural analgesia using levobupivacaine and fentanyl mixture.  intravenous saline infusion 100 ml followed by identification of epidural space using touhys needle 18G by loss of resistance to saline technique. epidural catheter is inserted and fixed. after giving 10 ml mixture of 0.1% levobupivacaine with 2mcg/ml fentanyl, PCEA pump started at 6 ml/hr with patient controlled bolus of 5 ml 
Intervention  intravenous paracetamol followed by epidural analgesia using levobupivacaine and fentanyl  intravenous paracetamol 1000 mg (100 ml) infusion followed by identification of epidural space using touhys needle 18G by loss of resistance to saline technique. epidural catheter is inserted and fixed. after giving 10 ml mixture of 0.1% levobupivacaine with 2mcg/ml fentanyl, PCEA pump started at 6 ml/hr with patient controlled bolus of 5 ml. the infusion will continue till the patient delievers. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  • American Society of Anesthesiologists (ASA) grade I and II
• Age >18 years
• Primigravida
• Single gestation
• Cephalic presentation at ≥ 36 wk of gestation
• In early spontaneous labour (cervical dilation ≤ 5 cm)
• Baseline pain score > 30 (on a 0-100 VAS)
• Able to use PCEA pump
• Requesting epidural analgesia for labour
 
 
ExclusionCriteria 
Details  • Refusal by parturient
• Parturients who had received parenteral opioids in the last 4 hours
• Systemic and local sepsis
• Deranged coagulation profile
• Parturients having multiple pregnancies and premature labour
• Obstetric complications (e.g., premature rupture of amniotic membranes)
• Noncephalic presentations
• Allergy to study drugs, i.e., paracetamol, levobupivacaine and fentanyl
 
 
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 
Hourly average consumption of levobupivacaine and fentanyl mixture, including both continuous background infusion plus bolus doses (in ml)  starting from 1 hour after administration of paracetamol or saline, till delivery. 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal satisfaction (VAS)
Pain score (VAS)
Sensory and motor block characteristics
Haemodynamic parameters of mother
Foetal heart rate
Duration of second stage of labour
Mode of delivery
Apgar scores
Adverse effects
 		 starting from 1 hour after administration of paracetamol or saline, till delivery. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/06/2013 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Labour is reported to be one of the most painful experiences for many women. Epidural analgesia is the most effective treatment available for pain control during labour and delivery, and it is a preferable method because it can provide more effective pain relief compared with other form of pharmacological analgesia. .The review of literature in the area of labour analgesia indicates that significant progress has been made with the advent of PCEA using a combination of low-concentration long-acting local anaesthetics (bupivacaine, levobupivacaine) and low-dose lipid soluble potent opioids (e.g., fentanyl). However, there is still scope of further improving the scenario by studying whether addition of a long-established safe and well-tolerated analgesic like paracetamol by the intravenous route to the intrapartum labour analgesia regime as above can reduce the total hourly consumption of the anaesthetic-opioid combination by the epidural route. If demonstrated to have PCEA drug-sparing effect, then this new regime could enhance the safety of the entire procedure for both mother and child without compromising analgesic efficacy.Therefore the aim of present study is to evaluate the efficacy of intravenous infusion of 1000 mg of paracetamol as an adjunct and its sparing effect on total consumption of levobupivacaine and fentanyl combination given as patient controlled epidural analgesia in labouring parturients

 

 
Close