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CTRI Number  CTRI/2024/03/064255 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 01/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) [Labor analgesia ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on injection dexamethasone through the vein with 0.1% ropivacaine through dural puncture epidural technique for labour pain relief 
Scientific Title of Study   Efficacy of intravenous dexamethasone as an adjuvant to 0.1% ropivacaine for labour analgesia using dural puncture epidural technique- A randomised double blinded 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  C Gokula varshini  
Designation  Post graduate  
Affiliation  Mahatma Gandhi medic college and research institute  
Address  Department of Anaesthesiology Second floor Mahatma Gandhi medical college and research institute, Pillayarkuppam, Cuddalore Rd, ECR, Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8778911579  
Fax    
Email  varshini97@icloud.com  
 
Details of Contact Person
Scientific Query  
Name  Rani P 
Designation  Professor  
Affiliation  Mahatma Gandhi medic college and research institute  
Address  Department of Anaesthesiology Second floor Mahatma Gandhi medical college and research institute, Pillayarkuppam, Cuddalore Rd, ECR, Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9443116908  
Fax    
Email  anaesrani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rani P 
Designation  Professor  
Affiliation  Mahatma Gandhi medic college and research institute  
Address  Department of Anaesthesiology Second floor Mahatma Gandhi medical college and research institute, Pillayarkuppam, Cuddalore Rd, ECR, Puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9443116908  
Fax    
Email  anaesrani@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi medic college and research institute  
 
Primary Sponsor  
Name  Mahatma Gandhi medical college and research institute 
Address  Mahatma Gandhi medical college and research institute. Pondicherry - Cuddalore Rd, ECR, Pillayarkuppam, Puducherry  
Type of Sponsor  Research institution and hospital 
 
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 C Gokula varshini  Mahatma Gandhi medical college and research institute   Department of Anaesthesiology 2nd floor Mahatma Gandhi medical college and research institute. Pondicherry - Cuddalore Rd, ECR, Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY 		 8778911579

varshini97@icloud.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi medical college and research institute, Institutional human ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 2||Placement, (2) ICD-10 Condition: 3||Administration, (3) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous dexamethasone before dural puncture epidural labour analgesia   Injection dexamethasone 8 mg with 50 ml of Saline is administered 30 minutes before placement of epidural.  
Comparator Agent  Normal saline before dural puncture epidural labour analgesia   50 ml of Saline is administered 30 minutes before placement of epidural.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Primi with singleton pregnancy
ASA 2 
 
ExclusionCriteria 
Details  1.Expectant mothers who have recently received parenteral opioid
2.systemic and local sepsis
3.abnormal coagulation profiles,
4. multiple pregnancies
5. non cephalic presentations, allergies to study drugs like ropivacaine and dexamethasone,
6.history of peptic ulcer disease uncontrolled diabetes. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare the duration of analgesia between control and study group.
 		 Time from patient having good pain relief after administration of the drug till patient complaining of moderate to severe pain.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Heart rate & mean arterial pressure between control & study group.   At 10 minutes intervals from the time of administration of epidural to the time of baby delivery.  
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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
Modification(s)  		 Phase 3 
Date of First Enrollment (India)   31/03/2024 
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 Applicable 
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  

This study involves recruiting primigravida patients through continuous sampling for safe confinement. After pre-anesthetic evaluation, eligible patients will be randomized into two groups (Group D and Group R). Group D receives IV Dexamethasone, while Group R receives a placebo. Patient is shifted to operating room and base line vitals noted. Dural puncture epidural is place at level of L2L3 OR L3L4 space. Epidural analgesia is administered using 0.1% ropivacaine 12ml , and its adequacy is assessed. If analgesia is inadequate, a repeat dose same drug is given. 

Quality of analgesia is evaluated by visual analogue score, verbal scoring system and motor blockade is assessed using a Modified Bromage score. 

Patients with no motor blockade are given a supervised trial walk. Analgesia duration is noted, and top-ups are given as needed if the patient VAS score is >3 during contractions.

Monitoring includes hemodynamic parameters for the mother and fetal heart rate at 15-minute intervals. The study aims to evaluate the effectiveness of Dexamethasone in labor analgesia.

 
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