| CTRI Number |
CTRI/2019/03/018186 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
19/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the pain relieving action of paracetamol injection inpatients after removal of gall bladder for stones (through small holes on the abdominal wall) when given through veins by two different methods upto 24hrs post-operatively |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of continuous intravenous infusion versus intermittent bolus of paracetamol in postoperative pain relief following laparoscopic cholecystectomy : A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparajita Panda |
| Designation |
Asst. Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Anaesthesiology
AIIMS, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884118 |
| Fax |
|
| Email |
aparajitahota@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparajita Panda |
| Designation |
Asst. Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Anaesthesiology
AIIMS, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884118 |
| Fax |
|
| Email |
aparajitahota@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparajita Panda |
| Designation |
Asst. Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Anaesthesiology
AIIMS, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884118 |
| Fax |
|
| Email |
aparajitahota@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Sijua, Patrapara, Bhubaneswar, Orissa - 751019 |
| 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 Aparajita Panda |
Department of Anaesthesiology, AIIMS, Bhubaneswar, Odisha |
Sijua, Patrapara, Bhubaneswar, Orissa - 751019
Khordha
ORISSA |
9438884118
aparajitahota@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Bhubneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus Paracetamol |
Injection Paracetamol 1g (100ml) will be given by intermittent intravenous boluses 8 hourly upto first 24 hours post-operatively |
| Intervention |
Infusion paracetamol |
Injection Paracetamol 3g (300ml) will be given by continuous intravenous infusion upto first 24 hours post-operatively |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Elective laparoscopic cholecystectomy patients |
|
| ExclusionCriteria |
| Details |
Allergy to paracetamol
Psychiatric patient
Patients on benzodiazepine therapy
Deranged liver function test
Emergency laparoscopic cholecystectomy patients
Alcoholics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in VAS score by 30% in the first 24hours postoperatively |
VAS score will be assessed post-operatively at hourly interval for the first 4 hours and then 8 hourly upto 24 hours, or on need basis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amount of rescue analgesics required in the first 24 hrs postoperatively |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised controlled trial comparing the analgesic efficacy of continuous intravenous infusion versus intermittent bolus of paracetamol in postoperative pain relief in the first 24 hours following laparoscopic cholecystectomy. The primary outcome measures will be reduction in VAS (Visual Analogue Score) during the first 24 hrs post-operatively. The amount of rescue analgesic consumed will also be assessed. |