| CTRI Number |
CTRI/2025/02/080056 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Paracetamol and Ibuprofen infusion on pain in patient posted for Abdominal Hysterectomy surgery with laparoscope |
|
Scientific Title of Study
|
A Prospective Randomized Comparision of Intravenous Paracetamol and Ibuprofen as Preemptive Analgesia in Total Laparoscopic Abdominal Hysterectomy |
| 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 Ravindra Kumar Gehlot |
| Designation |
Professor |
| Affiliation |
RNT Medical college Udaipur Rajasthan |
| Address |
Department of Anesthesiology,RNT Medical College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9468694902 |
| Fax |
|
| Email |
dr.rgehlot.2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Kumar Gehlot |
| Designation |
Professor |
| Affiliation |
RNT Medical college Udaipur Rajasthan |
| Address |
Department of Anesthesiology,RNT Medical College Udaipur Rajasthan
RAJASTHAN
313001
India |
| Phone |
9468694902 |
| Fax |
|
| Email |
dr.rgehlot.2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maneesh Meena |
| Designation |
Post Graduate Resident |
| Affiliation |
RNT Medical College Udaipur Rajasthan |
| Address |
Department of Anesthesiology,RNT Medical College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9660421480 |
| Fax |
|
| Email |
drmaneeshmeena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zanana Main Operation Theatre, 1st Floor, Pannadhay Zanana Hospital,RNT Medical College Udaipur(pin code-313001) Rajasthan India |
|
|
Primary Sponsor
|
| Name |
RNT Medical College Udaipur Rajasthan |
| Address |
Department of Anaesthesiology, RNT Medical College Udaipur (pin code-313001) Rajasthan India |
| 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 Maneesh Meena |
RNT Medical College |
Room no.2236, Zanana Main Operation Theatre, 2nd Floor, emergency building, Pannadhay Zanana Hospital,RNT Medical College Udaipur-313001, Rajasthan, India
Udaipur
RAJASTHAN |
9660421480
drmaneeshmeena@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: N72||Inflammatory disease of cervix uteri, (2) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ibuprofen infusion |
400 mg Ibuprofen infusion intravenous 15 minutes pre-operatively |
| Intervention |
Intravenous Paracetamol and Ibuprofen in Laparoscopic Abdominal Hysterectomy |
1000 mg Paracetamol infusion intravenous compared with 400 mg Ibuprofen infusion intravenous 15 minutes pre-operatively |
| Comparator Agent |
Paracetamol infusion |
1000 mg Paracetamol infusion intravenous 15 minutes pre-operatively |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients of ASA grade I-II
2) Patients scheduled for laparoscopic abdominal hysterectomy surgeries |
|
| ExclusionCriteria |
| Details |
1) Lack of patient consent
2) Drug dependence
3) History of long-term NSAIDs and opioid analgesic use
4) Patients allergic to ibuprofen and paracetamol
5) Patients with diabetes or other neuropathic diseases
6) History of gastrointestinal bleeding, peptic ulcer or inflammatory
bowel disease, asthma
7) Patients with severe hepatic or renal failure
8) Patients weighing less than 40 Kg |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia |
24 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)hemodynamic changes
2)the time to first analgesic requirement and total tramadol consumption
3)Adverse effects |
24 hours post-operatively |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
20/02/2025 |
| 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 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
|
My clinical study is pre-emptive intravenous paracetamol and ibuprofen for acute post operative pain in laparoscopisc abdominal hysterectomy. We want to study comparative effect of paracetamol and ibuprofen infusion on post operative pain. Kindly consider it for CTRI registrar. |