| CTRI Number |
CTRI/2013/10/004039 [Registered on: 01/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
22/09/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Post operative pain relief in laparoscopic surgery |
|
Scientific Title of Study
|
Post operative pain relief in Laparoscopic Cholecystectomy-comparison between intraperitoneal ropivacaine and bupivacaine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Babu |
| Designation |
Junior resident |
| Affiliation |
Father muller medical college |
| Address |
Dept of Anaesthesiology
Fathermuller medical college
Kankanady
mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8147917505 |
| Fax |
|
| Email |
rakeshbabu47@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRITHI JAIN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
father muller medical college |
| Address |
Dept of Anaesthesiology
Fathermuller medical college
kankanady
mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09845082487 |
| Fax |
|
| Email |
drprithiballal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAKESH BABU |
| Designation |
Junior Resident |
| Affiliation |
father muller medical college |
| Address |
Dept of Anaesthesiology
Father Muller Medical college
kankanady
mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8147917505 |
| Fax |
|
| Email |
rakeshbabu47@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
hospital |
| Address |
Father Muller Medical College
kankanady |
| Type of Sponsor |
Private 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 Rakesh Babu |
Post operative surgical ward,Father Muller Hospital |
FMMC Hospital
kankanady post
mangalore 2
Dakshina Kannada
KARNATAKA |
08147917505
rakeshbabu47@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comitte ,Father Muller Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
for laparoscopic cholecystectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.20% ropivacaine 20 ml and 0.25% bupivacaine 20ml used for comparison |
both drugs are injected intraperitoneally after completion of lap cholecystectomy. post op pain releif is assesed |
| Comparator Agent |
0.25% bupivacaine 20 ml |
injected intraperitoneally after completion of laparoscopic cholecystectomy.
post operative pian scores are compared in the study groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
posted for laparoscopic cholecystectomy,elective cases |
|
| ExclusionCriteria |
| Details |
patients with recent MI, difficult airway, asa 3 and 4 pateints |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post op pain releif |
post op pain releif |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post op pain releif,new drugs,routine for lap cholecystectomy |
upto 24hour postop |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2011 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study intends to find out post op pain relief after lap cholecystectomy. comparison between ropivacaine and bupivacane . |