| CTRI Number |
CTRI/2025/03/082242 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
The Role Of Pre Emptive Ketamine In Optimizing Post Operative Pain Control For Breast Surgery Patients |
|
Scientific Title of Study
|
Role Of Pre Emptive Ketamine In Post Operative Pain Control For Patients Undergoing Modified Radical Mastectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadira |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Junior Resident
Department Of Anaesthesiology
Government Medical College Kozhikode
Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9495478423 |
| Fax |
|
| Email |
nadiraummer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu.S |
| Designation |
Professor |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Professor
Department Of Anaesthesiology
Government Medical College Kozhikode
Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9447426051 |
| Fax |
|
| Email |
indusatish2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syamkumar.S |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Assistant Professor
Department Of Anaesthesiology
Government Medical College Kozhikode
Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9447801936 |
| Fax |
|
| Email |
shyamvadavanthur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Kozhikode
Medical College Junction,17,
Mavoor road,near Police Station Kozhikode,Kerala,India
673008 |
|
|
Primary Sponsor
|
| Name |
Dr Nadira |
| Address |
Junior Resident
Department Of Anaesthesiology
Government Medical College Kozhikode
Medical College Junction,17,Mavoor road, near Police Station, Kozhikode,
Kerala, India 673008 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Nadira |
Government medical college Kozhikode |
Oncosurgery operation theatre.Department of Anaesthesiology,Kozhikode,Kerala, India
Kozhikode
KERALA |
9495478423
nadiraummer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Government Medical College Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Adult female patients aged between 18 to 80 years undergoing modified radical mastectomy.
American Society Of Anaesthesiologist (ASA) physical status I,II and III. |
|
| ExclusionCriteria |
| Details |
Known history of drug or alcohol abuse
Patients with chronic pain syndrome
Past history of drug allergy
Liver failure
Renal insufficiency
Cognitive impairment with difficulties in pain evaluation
Psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the severity of post operative pain using Visual Analogue Scale score among post modified radical mastectomy patients who received and not received pre emptive ketamine. |
30 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the
Interval time for first rescue analgesic
Total number and dose of analgesic injections in first 24 hours.
Occurrence of adverse effects like hallucination,delirium and visual disturbances within first 24 hours |
Within 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
22/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nadiraummer@gmail.com].
- For how long will this data be available start date provided 14-12-2024 and end date provided 14-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a prospective observational study to determine the role of pre emptive intravenous ketamine in post operative pain control of patients undergoing modified radical mastectomy.The primary objective of the study is to assess the severity of post operative pain using Visual Analogue Scale score among post modified radical mastectomy patients who received and not received pre emptive ketamine.And the secondary objective of the study is to asses the Interval time for first rescue analgesic,Total number and dose of analgesic injections in first 24 hours,Occurence of adverse effects like hallucination,delirium and visual disturbances within first 24 hours.This study helps in determining the role of intravenous ketamine as pre emptive analgesic and its post operative analgesic sparing effect on patients undergoing modified radical mastectomy.Low dose ketamine (less than 1mg/kg) helps in attaining adequate post operative pain with minimal adverse effects and haemodynamic changes.Adequate post operative analgesia with opioid sparing and minimal adverse effects can help in increasing patient satisfaction. |