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CTRI Number  CTRI/2025/04/084763 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the analgesic effect of two drugs inj levobupivacaine by epidural method and inj tramadol by intravenous method for labour pain relief. 
Scientific Title of Study   Epidural analgesia verses IV Tramadol in labour analgesia: A Comparative study 
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 Rashi Mandhani 
Designation  PG Resident 
Affiliation  Pt JNM Medical College Raipur CG 
Address  Department of Obstetrics and Gynaecology Pt JNM Medical College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  7089533130  
Fax    
Email  rashimandhani12345@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti Jaiswal 
Designation  Professor and Head Of Department 
Affiliation  Pt JNM Medical College Raipur CG 
Address  Department of Obstetrics and Gynaecology Pt JNM Medical College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  9893231900  
Fax    
Email  dr.jyotijaiswal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyoti Jaiswal 
Designation  Professor and Head Of Department 
Affiliation  Pt JNM Medical College Raipur CG 
Address  Department of Obstetrics and Gynaecology Pt JNM Medical College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  9893231900  
Fax    
Email  dr.jyotijaiswal@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology Pt JNM Medical College Raipur ,CG, India ,pincode 492001 
 
Primary Sponsor  
Name  Pt JNM Medical College Raipur CG 
Address  Department of Obstetrics and Gynaecology Pt JNM Medical College Raipur ,Chhattisgarh, pin code 492001  
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 Rashi Mandhani  Dr Bhim Rao Ambedkar Memorial hospital, Raipur, Chhattisgarh  Obstetrics and Gynaecology OT, Labour Room, Department of Obstetrics and Gynaecology, Raipur, CG
Raipur
CHHATTISGARH 		 07089533130

rashimandhani12345@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The INSTITUTIONAL ETHICS COMMITTEE Pt JNM Medical College Raipur CG  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O749||Complication of anesthesia duringlabor and delivery, unspecified, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Epidural Analgesia  Epidural cathetor inserted as per standard protocol at 4 cm of cervical dilatation 
Comparator Agent  Epidural Levobupivacaine  Inj levobupivacaine 0.1% with Inj Fentanyl 2 mcg/ml,10ml bolus via epidural cathetor followed by infusion at 10ml/hr until delivery of baby 
Comparator Agent  Intravenous Tramadol  Inj Tramadol 1mg/kg IV bolus followed by 100mg Inj Tramadol in 500ml of NS as infusion until dleivery of baby 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women with singleton cephalic pregnancy requesting for labour analgesia at more than or equal to 37 weeks of gestation in active phase of labour . 
 
ExclusionCriteria 
Details  contraindication to vaginal delivery
contraindication to epidural
allergy to the drugs used
preterm pregnancy
medical complications in pregnancy
fetal distress 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Maternal Analgesia using VAS score  BP,PR, SPO2, FHR, VAS recorded initially in 15 min then after 1hourly till delivery 
 
Secondary Outcome  
Outcome  TimePoints 
duration of labour   after delivery 
maternal satisfaction using likert scale  at the end of procedure 
neonatal outcome  APGAR at 1 min and 5 min after birth 
mode of delivery  at the time if delivery 
side effects and complications  at the end of procedure 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   24/04/2025 
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   This is a randomised Interventional study comparing epidural levobupivacaine versus IV tramadol in terms of analgesic efficacy during labour. Parturients requesting for epidural or iv analgesia will enroll with a sample size of 86(43 in each group). Primary outcome will be maternal analgesia using VAS Score. secondary outcomes will be duration of labour, mode of delivery, neonatal outcome, and complication if any. Monitoring of vital signs(BP.PR.SPO2.FHR) will be done hourly until delivery. 
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