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CTRI Number  CTRI/2025/11/097884 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 18/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the effect of low dose of the drug Ketamine in reducing the pain after child is delivered in a caesarean section surgery 
Scientific Title of Study   Evaluation of efficacy of low dose ketamine in relieving intraoperative post child birth pain in lower segment caesarean section: a prospective, randomised, double-blind case control 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 Hemraj Tungria 
Designation  Professor 
Affiliation  RNT Medical College 
Address  Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9829370866  
Fax    
Email  htungaria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemraj Tungria 
Designation  Professor 
Affiliation  RNT Medical College 
Address  Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9829370866  
Fax    
Email  htungaria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arjun P Raj 
Designation  PG Resident 
Affiliation  RNT Medical College 
Address  Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  7736795665  
Fax    
Email  arjunpraj01@gmial.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, RNT Medical College, Udaipur, 313001 
 
Primary Sponsor  
Name  Maharana Bhupal Government Hospital 
Address  Department of Anaesthesiology, RNT Medical College, Udaipur, 313001 
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 Arjun P Raj  Maharana Bhupal Government Hospital  CLR OT, 2nd Floor, Pannadhay Zanana Hospital,RNT Medical College, Udaipur, Rajasthan
Udaipur
RAJASTHAN 
7736795665

arjunpraj01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS, UDAIPUR  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous Ketmaine for post child birth pain relief  Patient is given Ketamine of concentration 10mg/mL at a dose of 0.5mg/kg post child birth and pain VAS score is noted intraoperatively and post opertaively 
Comparator Agent  Intravenous Normal Saline for post child birth pain relief  Patient is given Normal Saline (Equivalent to the volume of Ketamine dosage) post child birth and pain VAS score is noted intraoperatively and post opertaively 
Intervention  the intra operative pain relief comparison   To determine the intraoperative pain relief, patient is given 0.5mg/kg Ketamine IV in comparison to patient receiving similar volume of NS, following child birth. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Parturients with Singleton pregnancy (37-42 weeks)
Elective LSCS
ASA Grade II 
 
ExclusionCriteria 
Details  Patient Refusal
Non cooperative Parturients
Patients with medical comorbidities like, cardiac diseases such as inadequate left ventricular ejection fraction (Ejection Fraction less than 45%), valvular or ischaemic heart disease, uncontrolled hypertension, heart blocks, arrhythmia, cardiac failure, uncontrolled diabetes mellitus, hepatic, renal, endocrine, haematological, autoimmune, psychiatric, neurological diseases, neuromuscular diseases, bronchial asthma, chronic obstructive pulmonary disease.
Allergy to study drug - Ketamine
Patients who participated in another study within 30 days
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Evaluate the intra operative pain relief achieved for the patient on giving 0.5 mg/kg of Ketamine intravenously following child delivery  After childbirth at 0,2,5,10,15,20,30 mins intraoperatively and at End of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the post operative analgesic effect of low dose ketamine  At 2,6 ,12 and 24 hours post operatively. 
To look for any adverse effects/complications associated with administration of ketamine   
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   10/12/2025 
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="0"
Months="6"
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  

­­­­A reasonable proportion of parturients undergo Caesarean delivery, due to varied indications. A good fraction of the caesarean deliveries takes place under the subarachnoid/spinal anaesthesia. This anaesthesia is considered the gold standard because it allows the woman to see the newborn intraoperatively, can provide good postoperative analgesia, and obviates need for airway manipulation. A potentially devastating complication of spinal anaesthesia for Caesarean Delivery is intraoperative pain also described as Pain during caesarean delivery (PDCD). The incidence of intra operative pain is around 11.9% in the population undergoing the surgery. Intraoperative pain can cause long term psychological and physical consequences. Significant pain during caesarean may affect the patient experience and has been associated as an independent risk factor for postpartum post-traumatic stress disorder. Pain associated with caesarean section may occur before the delivery of baby, after delivery of baby or may be present throughout the procedure. Preoperative anxiety may contribute to a pain sensation in initial duration of the procedure. Pain following child birth can be attributed to the use of oxytocin, uterus exteriorization, peritoneal or mesenteric pull, amniotic fluid embolism. Parturient may experience different types of pain and discomfort following birth, including cramping pain (often called after-birth pain) associated with uterine involution, where the uterus contracts to reduce blood loss and return the uterus to its non pregnant size.

Ketamine is an N-methyl-d-aspartate (NMDA) receptor inhibitor that causes analgesia by desensitization of stimulated N-methyl-d-aspartate receptor, thereby blocking pain signal in central nervous system. . Ketamine has a minimal effect on the central respiratory drive if given slowly, although rapid iv injection can cause transient apnoea. Ketamine may provoke imaginative, dissociative states and psychotic symptoms resembling schizophrenia due to its NMDA-antagonistic action, as well as severely impairing semantic and episodic memory. Subanaesthetic doses of ketamine prevent central sensitization, development of acute opioid tolerance, and hyperalgesia. Low-dose ketamine also decline the activity of brain structures that respond to noxious stimuli. It has effects on opioid receptors and stimulates monoaminergic descending inhibitory pathways at supraspinal sites causing in antinociception, all of which mediate analgesic effects. Ketamine is used increasingly in sub-anaesthetic doses as an adjuvant to local anaesthetics and opioids in multimodal pain therapy for acute pain management. 

The study aims at evaluation of the effect of intraoperative Ketamine administration in relieving the pain during caesarean section, as well as post operatively.

 
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