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CTRI Number  CTRI/2014/05/004596 [Registered on: 13/05/2014] Trial Registered Retrospectively
Last Modified On: 01/12/2015
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 compare the pain relief during labour using a epidural local anaesthetic and an opioid versus epidural local anaesthetic and opioid along with intravenous steroid(dexamethasone) 
Scientific Title of Study   Intravenous dexamethasone as an adjunct to patient-controlled epidural analgesia with levobupivacaine and fentanyl in labour: a randomized, double blind, placebo controlled study  
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratibha dube 
Designation  Post graduate junior resident 
Affiliation  GMCH chandigarh 
Address  Department of Anaesthesia and Intensive care, Level 5, Block D GMCH sector 32 Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  9815678146  
Fax    
Email  pratibhadube.dube@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Professor Sukanya Mitra 
Designation  Professor 
Affiliation  GMCH chandigarh 
Address  Department of Anaesthesia and Intensive care, Level 5, Block D GMCH sector 32 Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  9646121521  
Fax    
Email  drsmitra12@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratibha dube 
Designation  Post graduate junior resident 
Affiliation  GMCH chandigarh 
Address  Department of Anaesthesia and Intensive care, Level 5, Block D GMCH sector 32 Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  9815678146  
Fax    
Email  pratibhadube.dube@gmail.com  
 
Source of Monetary or Material Support  
GMCH Chandigarh 
 
Primary Sponsor  
Name  GMCH chandigarh 
Address  Department of Anaesthesia and Intensive care, Level 5, Block D, GMCH 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 Pratibha Dube  GMCH, Chandigarh  Department of Anaesthesia and Intensive care, Level-5, Block-D, GMCH, Sector-32, Chandigarh
Chandigarh
CHANDIGARH 		 9815678146

pratibhadube.dube@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee, GMCH Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  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) ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo group  This group will receive 50ml of normal saline 45 minutes before insertion of epidural catheter and will receive 10 ml of levobupivacaine 1mg/ml (0.1 percent) with 2μg/ml fentanyl epidural bolus followed by continuous background infusion of 5 ml of 0.1 percent of levobupivacaine with 2μg/ml of fentanyl. In addition, there will be a provision of patient-controlled bolus of 5 ml of 0.1 percent of levobupivacaine with 2μg/ml of fentanyl with a lock-out interval of 12min. 
Intervention  Steroid group  This group will receive dexamethasone 8mg intravenously diluted to 50 ml with normal saline 45 minutes before insertion of epidural catheter and will receive 10 ml of levobupivacaine 1mg/ml (0.1 percent) with 2μg/ml fentanyl epidural bolus followed by continuous background infusion of 5 ml of 0.1 percent of levobupivacaine with 2μg/ml of fentanyl. In addition, there will be a provision of patient-controlled bolus of 5 ml of 0.1 percent of levobupivacaine with 2μg/ml of fentanyl with a lock-out interval of 12min. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 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. levobupivacaine and fentanyl.
• H/O peptic ulcer disease.
• Known case of uncontrolled Diabetes Mellitus.
• Patient who have received dexamethasone in last 7 days for foetal lung maturity.
 
 
Method of Generating Random Sequence   Random Number Table 
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) corrected for the duration of labour.  At the end of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal satisfaction and Pain score (VAS)
 		 Every 5 min for the first 20 min and then every 1 h until delivery, on a 0-100 scale. 
Haemodynamic parameters of mother  5 min for the first 20 min and then every 1 h until delivery 
Sensory and motor block characteristics  Sensory block at midline every 5 min for the first 20 min and then every 1 h until delivery.
Lower limb motor block every 5 min using the modified Bromage scale  
Foetal heart rate  Continuous foetal heart rate monitoring. 
Apgar score  1 and 5 minute after delivery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 01/06/2014 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Will be notified 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Labour is the physiological process associated with severe pain, the multidimensional aspects and intensity of which far exceeds that of other conditions.Although severe pain in healthy parturient is not life-threatening, it can have numerous neuropsychological consequences.The goal of labour analgesia is to provide adequate pain relief without causing any maternal or foetal jeopardy. Continuous epidural analgesia is the most versatile and most commonly employed technique since it can be used for pain relief during labour and for subsequent vaginal delivery as well as analgesia and anaesthesia for ceasarean section, if necessary.

 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).studying whether addition of a long-established safe and well-tolerated adjuvant in multimodal postoperative analgesia like dexamethasone by the intravenous route to the intrapartum labour analgesia regime reduces the total hourly consumption of the local anaesthetic-opioid combination by the epidural route.   
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