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CTRI Number  CTRI/2024/04/065143 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to assess the short term and long-term adverse effects of labour epidural analgesia 
Scientific Title of Study   A Study on Short term and Long term Effects of Labour Epidural Analgesia in Parturients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  L R P PRASHIN 
Designation  Junior Resident 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9566800352  
Fax    
Email  prashinlrp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ANITA SHIRLEY JOSELYN 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162282105  
Fax  04162232035  
Email  anjeyanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  ANITA SHIRLEY JOSELYN 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162282105  
Fax  04162232035  
Email  anjeyanth@gmail.com  
 
Source of Monetary or Material Support  
Ethics Committee Silver, Office of Research, 1st Floor, Carman Block, Christian Medical College, Vellore 632002 
 
Primary Sponsor  
Name  L R P PRASHIN 
Address  Department of Anaesthesiology Christian Medical College Vellore 
Type of Sponsor  Other [Self] 
 
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 
L R P PRASHIN  Christian Medical College  Department of Anaesthesiology and Department of Obstetrics Labour Room Christian Medical College Vellore
Vellore
TAMIL NADU 		 9566800352

prashinlrp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Blue of Christian Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O80-O82||Encounter for delivery, (3) ICD-10 Condition: O618||Other failed induction of labor, (4) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL Intervention  Control group will be chosen by the Obstetrician with similar demographics similar to Epidural group. The control group will be given other modes of Analgesia. 
Comparator Agent  NIL Intervention  Labour epidural analgesia is a catheter based safe and effective technique for management of pain during labour by providing sensory block of lumbo-sacral plexus. Parturients satisfying the inclusion criteria will be selected for the study. The epidural space is identified by loss of resistance to saline technique and catheter is inserted into the space. Local anaesthetics and opioids will be given through epidural catheter to provide analgesia during labour. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Parturient requesting for labour epidural analgesia
2. Parturient with singleton pregnancy
3. Cephalic presentation with no CPD 
 
ExclusionCriteria 
Details  1. Women suffering from back pain before pregnancy due to the diagnosed spinal pathology or past history of back injuries.
2. Epidural contraindications - Coagulopathy, Local site infection, septicemia, Raised ICP
3. Anatomical deformity of Spine
4. Allergy to local anaesthetics
5. Elective C - section 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the outcome of labour in parturients with labour epidural analgesia. (Normal Vaginal Delivery/Instrument assisted delivery/
Caeserean Section )
 		 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Motor Block  24 hours 
Hypotension  24 hours 
Headache  24 hours 
Nausea/Vomiting
 		 24 hours 
Urinary Retention  24 hours 
Pruritis  24 hours 
Duration of 1st and 2nd stage of labour  24 hours 
Back pain  3 months 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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)   29/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/04/2024 
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)  Open to Recruitment 
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  
Abstract :
AIM :
This study is to assess the Short term and Long term effects of Labour Epidural Analgesia in
Parturients in comparison with parturients without labour epidural analgesia.

METHODOLOGY :

STUDY DESIGN : Observational study
After obtaining informed written consent, a structured proforma will be used to fill
the parturient’s - Name, Age, Hospital Number, Diagnosis, Co-morbidities, Gestational age,
Cervical dilatation, Phone number.

260 patients divided into two groups with 130 patients in each group.

A Questionairre will be filled by the primary observer after the first day of placement
of epidural catheter to observe the outcome and short term adverse effects of labour
epidural analgesia. Similarly the same questionairre will be filled by the primary investigator
for the control group. The control group will be chosen by the Obstetrician - parturients with
similar demographics of Epidural group.

Group A - Parturients with Labour Epidural Analgesia (130)
Group B - Parturients without labour epidural Analgesia (130)

PRIMARY OBJECTIVE : To study the outcome of labour in parturients with labour epidural
analgesia.

SECONDARY OBJECTIVE : To study the incidence of various other adverse effects of labour
epidural analgesia in parturients like :

Short Term
1. Motor Block
2. Hypotension
3. Headache
4. Nausea/Vomiting
5. Urinary Retention
6. Pruritis
7. Duration of 1st and 2nd stage of labour

 Long Term
1. Back Pain

Score/ Scale Used: 

1. Mode of Delivery - Normal Vaginal Delivery/Instrument assisted delivery/
Caeserean Section
2. Back pain - Numeric Pain Scale, Self report (Yes/No)
3. Motor Block - Bromage score
4. Adverse effects of epidural analgesia like hypotension, pruritis, nausea, urinary
retention, headache (Yes/No)
5. Duration of second stage of labour ( Prolonged 2nd stage - >180 minutes)
The primary observer will follow up the patient through telephone after 3 months for both
the groups to note the long term adverse effects.

Long Term Effects :
1. Back Pain - Numeric Pain Scale, Self report (Yes/No) If yes, impact of back pain on
daily activities and sleep(Yes/No)
With the above information we hope to find out the outcome of labour and adverse
effects in parturients with labour epidural analgesia in comparison with parturients without
labour epidural analgesia.

OUTCOME :
1. To find out the outcome of labour in parturients with labour epidural analgesia.
2. To find out short term and long term adverse effects -
a) Back pain
b) Motor Block
c) Hypotension, Pruritis, Nausea, Urinary retention, headache
d) Outcome of labour
e) Duration of second stage of labour
 
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