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CTRI Number  CTRI/2024/07/069716 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 29/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of Epidural Fentanyl to Epidural Dexmedetomidine on Requirement of Ropivacaine Dose in Patient Controlled Pain relief with epidural During Delivery  
Scientific Title of Study   Comparison Of Epidural Fentanyl to Epidural Dexmedetomidine on Requirement of Ropivacaine in Patient Controlled Epidural Analgesia During Labour Double Blinded Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sufiya Muskan T 
Designation  Post Graduate Student in Department of Anaesthesiology Vijayanagar Institute of Medical Sciences  
Affiliation  Vijayanagar Institute of Medical Sciences, Rajiv Gandhi University of Health Sciences. 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences Cantonment Ballari India

Bellary
KARNATAKA
583104
India 
Phone  8951987372  
Fax    
Email  muskan.hukrani01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sufiya Muskan T 
Designation  Post Graduate Student in Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences, Rajiv Gandhi University of Health Sciences. 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences Cantonment Ballari India

Bellary
KARNATAKA
583104
India 
Phone  8951987372  
Fax    
Email  muskan.hukrani01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Parimala 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Vijayanagar institute of medical sciences Cantonment Bellary KARNATAKA India

Bellary
KARNATAKA
583104
India 
Phone  9742530338  
Fax    
Email  dr.parimaladu@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences 
Address  Cantonment Ballari 583104 
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 Sufiya Muskan  Vijayanagar institute of medical sciences  Department of Obstetrics and Gynaecology ,Labour Room, MCH Block Cantonment Bellary Karnataka
Bellary
KARNATAKA 
8951987372

muskan.hukrani01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VIMS Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmeditomedine Group  Patient will receive the 10ml loading dose of 0.1% Ropivacaine with Dexmedetomidine 0.4mcg/ml followed by continuous background infusion by patient controlled analgesia pump at rate of 6ml/hr. When the NRS is ≥ 4, rapid bolus injection of 6ml with lockout period of 20minutes will be delivered by a patient controlled analgesia pump. 
Intervention  Fentanyl Group  Patient will receive 10ml loading dose of 0.1% Ropivacaine with fentanyl 2μg/ml followed by continuous background infusion by patient controlled analgesia pump at rate of 6ml/hr . Patients are instructed to use the pump by pressing the button whenever they feel more pain(NRS of ≥ 4).Rapid bolus injection of 6ml with lockout period of 20minutes will be delivered by a patient controlled analgesia pump. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 Full term parturients with 37 weeks or greater period of gestation, both primi and multigravida.
2 Singleton pregnancy with vertex presentation.
3 Inactive phase of labour cervical dialation 3 to 4 cms
4 Age more than 20years
5 ASA-2
6 Willing to give consent for labour epidural analgesia
7 Parturient who can understand and able to use PCA pump
 
 
ExclusionCriteria 
Details  1.Allergy to any of the study drugs
2.Patients with history of significant disorders (Pregnancy induced hypertension, diabetes mellitus, obstetric haemorrhage, other cardiovascular, respiratory, central nervous system or renal system disorders)
3.Significant coagulopathy
4.Other contraindications: localized sepsis, raised ICP etc.
5.Previous LSCS
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Consumption of Total Dose of Ropivacaine 0.1% in Both the Groups by Patient Controlled Epidural Analgesia in Labour  From 4cm Cervical Dilatation till the End of Stage 3 of Labour 
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of Patient Controlled Analgesia demand bolus
2.NRS at various intervals
3.Maternal SBP, DBP, MAP PR,SPO2,ECG,RR, Temperature
4.Continues FHR monitoring (CTG)
5.Duration of stages of labour-stage 1,2 & 3
6.Incidence of spontaneous delivery, assisted delivery & LSCS
7.Maternal satisfaction -1to 5 scale
8.Neonatal outcome (apgar score1and 5 minutes)
9.Complications such as hypotension,Bradycardia,desaturation, nausea vomiting pruritis
 
Number of Patient Controlled Analgesia demand bolus - from 4cm cervical dilatation till end of stage 3 of labour
NRS at various intervals - Prior to Epidural Catheter Placement, After Every 10 minutes Interval For 60 Minutes & Thereafter Hourly Till completion of Labour
Maternal SBP, DBP, MAP PR,SPO2,ECG,RR,Temperature-Prior to Epidural Catheter Placement, After Every 10 minutes Interval For 60 Minutes & Thereafter Hourly Till completion of Labour
Maternal satisfaction- At the end of labour



 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   10/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·       Parturient will be explained about the procedure and informed written consent is obtained. 

·       Thorough pre anaesthetic evaluation is performed  and routine investigations will be  obtained

·       Foetal status, labour status (frequency and duration of labour pain and cervical dilatation)will be assessed and noted both clinically and with Cardiotocography (CTG). A large bore peripheral intravenous catheter 18G/20G will be inserted and standard monitores such as NIBP ,Pulse oximeter, ECG,FHR monitors are connected. Baseline hemodynamic parameters will be recorded

·       Under strict aseptic precautions epidural space is identified with patient in left lateral position by midline approach using 18 G Tuohy’s needle in L3-4 or L4-L5 interspace with loss of resistance to saline technique and catheter is threaded cephalad 3 to 4 cms into epidural space. After negative aspiration for blood and CSF, a test dose of 3ml of lignocaine 2% with 1:2, 00, 000 adrenaline will be administered through the catheter, monitored for 5 min and connected to patient controlled analgesia (PCA) pump.[B BRAUN Perfusor space]

·       Patients are then randomized into two groups of 25 patients each based on randomly generated numbers as obtained from website www.randomizer.org. Allocation concealment is done using serially numbered opaque envelope (SNOSE) method into GROUP A and GroupB.

 

·       Group A will receive the 10ml loading dose of  0.1% Ropivacaine with Dexmedetomidine 0.4mcg/ml followed by continuous background infusion by patient controlled analgesia pump at rate of 6ml/hr. When the NRS is ≥ 4, rapid bolus injection of 6ml with lockout period of 20minutes will be delivered by a patient controlled analgesia pump.

·       GROUP B: will receive 10ml loading dose of 0.1% Ropivacaine with fentanyl 2μg/ml followed by continuous background infusion by patient controlled analgesia pump at rate of 6ml/hr . Patients are instructed to use the pump by pressing the button whenever they feel more pain(NRS of ≥ 4).Rapid bolus injection of 6ml with lockout period of 20minutes will be delivered by a patient controlled analgesia pump. The study drug for epidural analgesia will be prepared by another resident who is not involved in study. Patients and primary investigator both are blinded to study drug.

·       Parturients are monitored for haemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP),Mean arterial pressure(MAP), SpO2 ,Respiratory rate, Temperature every 10min interval for 60 minutes and thereafter hourly till completion of labour along with Fetal heart rate(FHR)

·       NRS Score[8] (numerical pain rating scale)- To assess the intensity of labour pain,0-10(0=no pain,10=worst imaginable pain). It is assessed prior to epidural catheter placement,after every 10minutes interval for 60 minutes and thereafter hourly till completion of labour

Numerical rating Scale (NRS) [14]. | Download Scientific Diagram

 

·       The duration of stages of labour (hrs)

 1ststage(starts from the onset of true labour pain and ends with full dilatation of cervix=10cm), 2nd stage (starts from full dilatation of cervix and ends with delivery of baby), 3rd stage (begins after baby delivery ends with expulsion of placenta)

·       Mode of delivery(spontaneous vaginal delivery/forceps/vacuum)

·       Incidence of caesarean delivery

·       The  sensory block- by pinprickmethod and time noted for block to reach T10 dermatomal level after administering bolus dose

·       The motor block - by modified Bromage scale[4]

Modified Bromage scale

0- No motor block                                                                                                      

1- Inability to raise extended leg: able to move knees and feet

2- Inability to raise extended leg and move knee able to move feet

3- Complete block of motor limb

·       The patients are monitored for the adverse effect such as hypotension, bradycardia, nausea vomiting, pruritis, desaturation, maternal sedation (Ramsay sedation scale)[9]

Score

Level of Sedation

1

Patient Is anxious and agitated or restless, or both

2

Patient is co-operative. Oriented. and tranquil

3

Patient responds to commands only

4

Patient exhibits brisk response to light tactile stimuli or loud auditory stimulus

5

Patient exhibits sluggish response to light tactile stimuli or loud auditory stimulus

6

Patient exhibits no response

 

Hypotension(less than 20% of baseline SBP) is treated with i.v ephedrine 5mg

Bradycardia(HR<60/min) is treated with atropine 0.6mg

Nausea and Vomiting treated with 4mg i.v ondansetron

After the delivery, neonatal APGAR scores at 1 and 5 minutes are assessed and managed as per neonatal resuscitation protocol

Maternal satisfaction will be assessed by using 1-5 verbal score(1=not satisfied at all  5=extremely satisfied)

Desaturation(spo2<92%) will be treated with 5-8l of oxygen by simple face mask.

·       The number of PCA demand boluses ,total consumption of 0.1% Ropivacaine , Dexmedetomidine 0.5mcg/ml and Fentanyl 2mcg/ml, hourly requirement of epidural ropivacaine ( calculated as the total consumed ropivacaine 0.1% volume divided by infusion duration) during study period will be noted and compared in both groups.

 

 
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