| CTRI Number |
CTRI/2025/10/095532 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of intravenous paracetamol Pre operativey for post operative pain control in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
EFFECT OF INTRAVENOUS PARACETAMOL AS PREEMPTIVE ANALGESIC FOR POST OPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY
|
| 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 Daisy Rani Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Gauhati Medical College And Hospital
Department Of Anaesthesia And Critical Care
Kamrup
ASSAM
781032
India |
| Phone |
8723980716 |
| Fax |
|
| Email |
Daisyranidas1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biswajit Talukdar |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Gauhati Medical College and Hospital
Department Of Ananesthesia And Critical Care
Kamrup
ASSAM
781032
India |
| Phone |
7002297736 |
| Fax |
|
| Email |
biswa.amc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biswajit Talukdar |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Gauhati Medical College and Hospital
Kamrup
ASSAM
781032
India |
| Phone |
7002297736 |
| Fax |
|
| Email |
biswa.amc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College And Hospital ,Guwahati, 781032, Kamrup, Assam, India. |
|
|
Primary Sponsor
|
| Name |
Daisy Rani Das |
| Address |
Gauhati medical college and hospital, Department Of Anaesthesia And Critical Care |
| 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 |
| Dr Daisy Rani Das |
Gauhati medical college and hospital |
Department of anesthesiology and critical care, gauhati medical college and hospital, gauwhati, kamrup, assam
Kamrup
ASSAM |
8723980716
Daisyranidas1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, GAUHATI MEDICAL COLLEGE AND HOSPITAL, GUWAHATI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
.9% Normal saline as placebo |
10mg/kg paracetemol as preemptive analgesic for post operative analgesia comparing with placebo .9%NS |
| Intervention |
10mg/kg paracetemol |
intravenous paracetemol 10mg/kg as preemptive analgesic for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II
Adults of age 18years-60 years
Duration of surgery less than equal to 90min |
|
| ExclusionCriteria |
| Details |
Patient refusal
History of allergy to the paracetemol
Bleeding disorder
History of use of paracetemol, nsaids,opids within 48hrs for chronic pain
Surgeries converted to open cholecystectomies |
|
|
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 efficacy of preemptive use of intravenous paracetamol for post operative pain through visual analogue score (VAS) on patients undergoing elective laparoscopic cholecystectomy |
To evaluate the efficacy of preemptive use of intravenous paracetamol for post operative pain through visual analogue score (VAS) on patients undergoing elective laparoscopic cholecystectomy,
T1-15min, T2- 30 min, T3- 1 hr, T4-2hr, T5- 8hr, T6- 12 hr, T7- 24hr post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate total consumption of rescue analgesic in first 24 hr.
To compare the intraoperative and postoperative vitals among the two groups. |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/10/2025 |
| 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
Modification(s)
|
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 - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 10-08-2025 and end date provided 13-11-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective, double-blind,randomised control study to be conducted in the general surgery operation theater under the Department of Anesthesiology And Critical Care, GMCH. The study will be carried out in adult patients of both sexes, posted for elective laparoscopic cholecystectomy . the aim of the study is compare the efficacy of preemptive use of intravenous 10mg/kg paracetemol and placebo for post operative analgesia. The primary obesctive is to evaluate the efficacy of preemptive use of intravenous paracetemol for post operative pain through VAS on the patients undergoing elective laparoscopic cholecystectomy and the secondary objectives is to evaluate post operative total rescue analgesic consumotion in first 24 hr and to monitor and compare the intraoperative and postoperative vitals among the two groups |