| CTRI Number |
CTRI/2022/11/047573 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief with intravenous ketamine after cesarean section |
|
Scientific Title of Study
|
THE EFFECT OF LOW DOSE INTRAVENOUS KETAMINE ON POSTOPERATIVE PAIN FOLLOWING CESAREAN SECTION WITH SPINAL ANESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chethana M |
| Designation |
Junior resident |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
418, gosala, 60ft road, health layout, Annapoorneshwari Nagar, Nagarbhavi, bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9538864779 |
| Fax |
|
| Email |
chethu.mahesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Rangalakshmi |
| Designation |
Professor and HOD |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Dept of Anesthesiology, Rajarajeswari Medical college and hospital, Kambipura, Mysore Road, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9901703030 |
| Fax |
|
| Email |
rangbharat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Rangalakshmi |
| Designation |
Professor and HOD |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Dept of Anesthesiology, Rajarajeswari Medical college and hospital, Kambipura, Mysore Road, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9901703030 |
| Fax |
|
| Email |
rangbharat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeshwari medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Chethana M |
| Address |
Rajarajeshwari medical college and hospital |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chethana M |
Rajarajeswari medical college and hospital |
2nd floor, Department of anesthesiology, kambipura, Mysore Road, Banglore 560074
Bangalore
KARNATAKA |
9538864779
chethu.mahesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low dose intravenous ketamine |
Five minutes after delivery, women in the experimental group will be given 0.25 mg/kg intravenous ketamine via bolus dose |
| Comparator Agent |
Normal saline. |
Five minutes after delivery, women in the first group receive normal saline. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA I to II Patients Female patients.
Aged between 20 to 40years.
Normal liver and renal function test, Coagulation profile.
Undergoing Lower Segment Caesarean Section Surgery. |
|
| ExclusionCriteria |
| Details |
Patients with history of allergy to local Anaesthetics.
Patients with history of mental disorders.
Patient Refusal.
Morbid obesity, Coagulopathy and significant cardiovascular respiratory, renal, hepatic or metabolic diseases or CNS disorders.
Patients with hypertensive disorder due to any cause ( PIH)
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of post operative pain relief with single dose of intravenous ketamine during cesarean section |
A visual analogue score will be used to record the participants pain score at 1, 2, 6, 12 hours following surgery. Participants will be asked to rate the intensity of their pain in the scale of one (no pain at all) to 10 (very intense and unimaginable pain). |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
First rescue analgesia used.
Total analgesic consumed in first 24hrs
Hemodynamic parameters for 24 hours post operatively.
Adverse effects, if any.
|
Participants will be monitored for common side effects, such as nausea, vomiting, headache, hallucination, and itching, and the prevalence of such side effects will be recorded at 1,2,6 and 12 hrs following surgery. |
|
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Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/11/2022 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Cesarean section is one of the most common surgeries in the world. Controlling the postoperative pain and getting the new mother out of bed and moving as early as possible following the surgery will reduce the respiratory, cardiovascular, urinary and digestive side effects of surgery.
Opioids such as morphine and pethidine are most commonly used premeditations for postoperative pain. However opioids have numerous side effects such as addiction, respiratory depression, drug resistance, nausea and vomiting. Therefore, use of non-opioid analgesics for postoperative pain is preferred. In this study we examine the effect of intravenous low dose ketamine on postoperative pain and need for analgesics, including opioids, following cesarean section with spinal anaesthesia using bupvicaine.
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