| CTRI Number |
CTRI/2024/01/061688 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFECT OF ONE GRAM OF INTRAVENOUS PARACETAMOL GIVEN PRIOR TO ANAESTHESIA ON POST OPERATIVE PAIN MANAGEMENT IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES – A RANDOMIZED CONTROL TRIAL |
|
Scientific Title of Study
|
EFFECT OF PREEMPTIVE ONE GRAM OF INTRAVENOUS PARACETAMOL ON POST OPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES – A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikkina Kesava Phani Kumar |
| Designation |
Junior Resident, Department of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences,Sevagram |
| Address |
Department of Anaesthesiology,Main Operation Theatre Complex, Mahatma Gandhi Institute of Medical Sciences,Sevagram, Wardha, Maharashtra
Wardha
MAHARASHTRA
442102
India |
| Phone |
8985564634 |
| Fax |
|
| Email |
kesavbikkina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sucheta Tidke |
| Designation |
Director Professor and HOD,Department of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences,Sevagram |
| Address |
Department of Anaesthesiology, Main Operation Theatre Complex,Mahatma Gandhi Institute of Medical Sciences,Sevagram, Wardha, Maharashtra
Wardha
MAHARASHTRA
442102
India |
| Phone |
8985564634 |
| Fax |
|
| Email |
suchetatidke@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bikkina Kesava Phani Kumar |
| Designation |
Junior Resident, Department of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences,Sevagram |
| Address |
Department of Anaesthesiology, Main Operation Theatre Complex,Mahatma Gandhi Institute of Medical Sciences,Sevagram, Wardha, Maharashtra
Wardha
MAHARASHTRA
442102
India |
| Phone |
8985564634 |
| Fax |
|
| Email |
kesavbikkina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Institute of Medical Sciences, Sevagram |
| Address |
Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra 442102 |
| 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 |
| DrBikkina Kesava Phani Kumar |
Main OT Complex,Kasturba Hospital, Mahatma Gandhi Institute of Medical Sciences, Sevagram |
Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra 442102
Wardha
MAHARASHTRA |
8985564634
kesavbikkina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Institute of Medical Sciences, Sevagram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K811||Chronic cholecystitis, (2) ICD-10 Condition: K36||Other appendicitis, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline Intravenous Injection |
100 millilitres of Normal Saline as placebo to be given over 10 minutes preemptive to laparoscopic procedures in ASA1 and ASA2 patients of age 18-60 years to study its effect on post operative analgesia |
| Intervention |
Paracetamol One Gram Intravenous Injection |
Single Dose of One Gram Intravenous Injection of Paracetamol is given over 10 minutes preemptive in laparoscopic procedures of ASA1 and ASA2 patients of age 18-60 years to study its effect on post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged between 18 and 65 years. 2) Patients scheduled for Elective laparoscopic surgeries. 3) Patients ready to give written informed consent. 4) Patients belonging to ASA Grade-I and II. |
|
| ExclusionCriteria |
|
|
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 |
| Post operative analgesia |
15 minutes, 30minutes, 1 hour, 2 hours, 4 hours of post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications like Post operative nausea, vomiting and time needed for rescue analgesia |
15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 3 |
|
Date of First Enrollment (India)
|
25/01/2024 |
| 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="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [to].
- For how long will this data be available start date provided 25-01-2024 and end date provided 30-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
We are studying the effect of preemptive one gram of intravenous paracetamol on post operative analgesia in patients undergoing laparoscopic surgeries in comparision with 100 millilitres of Normal Saline |