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CTRI Number  CTRI/2022/08/045029 [Registered on: 29/08/2022] Trial Registered Prospectively
Last Modified On: 28/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A scientific research to be conducted among women in labour to reduce labour pain using either of the two injections 
Scientific Title of Study   A randomized controlled trial comparing Intravenous Paracetamol infusion versus Intramuscular Tramadol as an intrapartum labour analgesic in a tertiary care hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Elamathi T 
Designation  1st year post graduate in Department of Obstetrics and Gynecology  
Affiliation  Indira Gandhi Medical College and Research Institute 
Address  33, Iyyanar kovil street Thattanchavady
Kathirkamam Puducherrry
Pondicherry
PONDICHERRY
605009
India 
Phone  9003952684  
Fax    
Email  elamathiteva@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ananathi K 
Designation  Professor in Department of Obstetrics and Gynecology 
Affiliation  Indira Gandhi Medical College and Research Institute 
Address  Indra Gandhi Medical college and research institute
Kathirkamam Puducherrry
Pondicherry
PONDICHERRY
605009
India 
Phone  9442882958  
Fax    
Email  ananthiray@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Elamathi T 
Designation  1st year post graduate in Department of Obstetrics and Gynecology  
Affiliation  Indira Gandhi Medical College and Research Institute 
Address  33, Iyyanar kovil street Thattanchavady
Kathirkamam Puducherrry
Pondicherry
PONDICHERRY
605009
India 
Phone  9003952684  
Fax    
Email  elamathiteva@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Medical College and Research Institute Puducherry 605 009 
 
Primary Sponsor  
Name  Indira Gandhi Medical college and Research Institute 
Address  Indira Gandhi Medical college and Research Institute Kathirkamam Puducherry 
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 
Elamathi T  Indira Gandhi Medical College and Research Institute in the Department of Obg in Labour ward  Kathirkamam Puducherry
Pondicherry
PONDICHERRY 
9003952684

elamathiteva@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women  
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  intramuscular Tramadol 50 mg  injection Tramadol 50 mg tramadol will be administered intramuscular, in the upper outer quadrant of the gluteal region will be administered as 1st dose if patient requires a second dose will be administered after 5 hours of 1st dose with Visual analogue score of 6 or more 
Intervention  intravenous Paracetamol 1000 mg in 100 ml solution  intravenous infusion of 1000 mg paracetamol in 100 ml solution over 15 min using a standard gravity‑dependent IV infusion set, in which each 16 drops give 1 ml (infusion rate about 130 drops/min) will be administered as 1st dose if patient requires a second dose will be administered after 5 hours of 1st dose with Visual analogue score of 6 or more 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Antenatal women in labour with cervical dilatation 3cm
Term gestation
Spontaneous onset of labour
Singleton pregnancy with vertex presentation
 
 
ExclusionCriteria 
Details  Women with cephalopelvic disproportion
Previously scarred uterus (post myomectomy, post cesarean)
History of any drug allergy
Medical disorders complicating pregnancy like severe anemia, gestational diabetes mellitus, cardiac disease, pregnancy induced hypertension, pre-existing liver disorders, seizure disorders.
Non-reassuring NST
Intrauterine growth restriction (IUGR)
Intrauterine foetal death
Patients on antidepressants (e.g. SSRI)
Patients who are not willing to participate
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain relief as noted in the visual analogue score  baseline, 1 h, 3 hrs and 5 hrs drug administration 
 
Secondary Outcome  
Outcome  TimePoints 
Interval between drug administration and delivery  time of delivery 
 
Target Sample Size   Total Sample Size="152"
Sample Size from India="152" 
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)   01/09/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study will commence after obtaining IRC & IEC approval. It is a randomized controlled trial done over a period of 18 months among 152 pregnant women in spontaneous labour in the department of Obstetrics & Gynecology at IGMC&RI. This study will compare the efficacy of intravenous Paracetamol Versus Intramuscular tramadol to alleviate labour pain in pregnant women. Details of the study will be explained to the participants and informed written consent will be obtained from them.

A simple random sampling method will be used in this study to recruit the subjects. Patients are assigned to either of the two groups by balloting. Two sets of 76 opaque envelopes containing piece of paper labelled as A or B will be prepared and mixed thoroughly  and placed in a box in the labor ward. An envelope will be picked up by each consecutive patient who consented and fulfilled the inclusion criteria. 

Antenatal women in spontaneous labour at 3cm cervical dilatation, satisfying the inclusion criteria are recruited after obtaining consent. Visual Analogue scale (VAS) will be used to assess pain intensity.

The initial pain perception is assessed at 3 cm cervical dilatation using the VAS, then patients are randomised into two groups A and B. For patients in Group A -50 mg of  tramadol will be administered intramuscularly, in the upper outer quadrant of the gluteal region. For patients in Group B, an IV infusion of 1000 mg paracetamol in 100 ml solution over 15 min using a standard gravity’ dependent IV infusion set, in which each 16 drops give 1 ml (infusion rate about 130 drops/min) will be administered . The severity of labour pain will be assessed subsequently at 1 hour, 3 hours and 5 hours after drug administration, in both groups using VAS and the score is recorded in number grading scale.

 The progression of labour will be monitored using WHO Partogram and standard institutional protocol will be followed for conducting delivery. A second or rescue dose will be administered for patients in both the groups after 5 hours of initial drug administration, if pain relief is inadequate, that is, a numerical rating of 6 and above on VAS, and this is recorded.

The expected outcome is that intravenous Paracetamol is expected to have better analgesic efficacy, shorter duration of labour  and fewer side-effects, when compared to intramuscular Tramadol, during labour. Hence in low resource settings, intravenous Paracetamol maybe used to provide labour analgesia.


 
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