| 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
|
|
|
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
|
|
|
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. |