| CTRI Number |
CTRI/2023/06/053604 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
05/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Ropivcaine Versus Bupivacaine intrapeitoneal instillation in postoperative pain relief in laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
COMPARISON OF ROPIVACAINE VERSUS BUPIVACAINE IN INTRAPERITONEAL INSTILLATION FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raavi Swapna Lakshmi Priya |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
| Address |
DR.D.Y.Patil Medical College,Hospital And Research Centre,Department of Anaesthesia,SantTukaram Nagar,Pimpri,Pune.
DR.D.Y.Patil Medical College,Hospital And Research Centre,Department of Aanaesthesia,SantTukaram Nagar,Pimpri.
Pune
MAHARASHTRA
411018
India |
| Phone |
09494901213 |
| Fax |
|
| Email |
swapnapriyanani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHAHBAZ HASNAIN |
| Designation |
PROFESSOR |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
| Address |
DR.D.Y.Patil Medical College,Hospital And Research Centre,Department Of Anaesthesia,SantTukaram Nagar,Pimpri,Pune.
DR.D.Y.Patil Medical College,Hospital And Research Centre,Department Of Anaesthesia,SantTukaram Nagar,Pimpri.
Pune
MAHARASHTRA
411018
India |
| Phone |
9764621253 |
| Fax |
|
| Email |
shahbazhsnn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHAHBAZ HASNAIN |
| Designation |
PROFESSOR |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
| Address |
DR.D.Y.Patil Medical College,Hospital And Research Centre,Department Of Anaesthesia,SantTukaram Nagar,Pimpri,Pune.
DR.D.Y.Patil Medical College,Hospital And Research Centre,Department Of Anaesthesia,SantTukaram Nagar,Pimpri,pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9764621253 |
| Fax |
|
| Email |
shahbazhsnn@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL PHARMACAY,HIGHTECH OT 5TH FLOOR |
|
|
Primary Sponsor
|
| Name |
Dr SWAPNA LAKSHMI PRIYA |
| Address |
DR.D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SANT TUKARAM NAGAR,PIMPRI,PUNE |
| 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 |
| DRRaavi Swapna Lakshmi Priya |
DR.D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
DR.D.Y.Patil Medical College Hospital And Research Centre,Department Of Anaesthesia,Sant Tukaram Nagar,Pimpri.
Pune
MAHARASHTRA |
9494901213
swapnapriyanani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Meeting Of Research And Recognition Committee under the faculty of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I AND ASA II |
| Patients |
(1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRAPERITONEAL INSTILLATION |
COMPARISON OF 0.375%ROPIVACAINE[35ML] VERSUS 0.25%BUPIVACAINE[35ML] IN INTRAPERITONEAL INSTILLATION FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY.
Duration-24hours |
| Comparator Agent |
INTRAPERITONEAL INSTILLATION OF BUPIVACAINE |
INTRAPERITONEAL INSTILLATION OF 0.25%BUPIVACAINE[35ml]FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY.
Duration-24hours. |
| Comparator Agent |
INTRAPERITONEAL INSTILLATION OF ROPIVACAINE |
INTRAPERITONEAL INSTILLATION OF 0.375% ROPIVACAINE[35ml] FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY.
Duration-24hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I AND II PATIENTS.
AGES BETWEEN 18 TO 65 YEARS OF EITHER SEX.
AVAILABILITY OF RETURN INFORMED CONBSENT.
PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANESTHESIA.
HEMODYNAMICALLY STABLE PATIENTS WITH ALLL ROUTINE INVESTIGATIONS WITHIN NORMAL LIMITS. |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH ASA PHYSICAL STATUS III OR MORE.
PATIENTS BELOW 18 YEARS AND ABOVE 65 YEARS.
PATIENTS POSTED FOR EMERGENCY PROCEDURES.
PATIENTS WITH MAJOR NEUROLOGICAL,CARDIAC,RESPIRATORY,RENAL,METABOLIC,HEPATIC DISEASES OR WITH COAGULATION ABNORMALITY.
PATIENTS WITH KNOWN ALLERGIC TO STUDY DRUG.
PATIENTS UNWILLING TO GET ENROLLED. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECTIVENESS OF 0.375% ROPIVACAINE[35ML] IN INTRAPERITONEAL INSTILLATION FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY. |
T0-IMMEDIATE POST OPERATIVELY,
T1-HOURLY TILL 4HOURS
T2-EVERY 4TH HOURLY UPTO 12 HOURS.
T3-EVERY 6TH HOURLY UPTO 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECTIVENESS OF 0.25%BUPIVACAINE[35ML] IN INTRAPERITONEAL INSTILLATION FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY. |
T0-IMMEDIATE POST OPERATIVELY,
T1-HOURLY TILL 4HOURS
T2-EVERY 4TH HOURLY UPTO 12 HOURS.
T3-EVERY 6TH HOURLY UPTO 24 HOURS |
|
|
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)
|
15/06/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
MY THESIS IS ABOUT COMPARISON OF ROPIVACAINE VERSUS BUPIVACAINE IN INTRAPERITONEAL INSTILLATION IN LAPAROSCOPIC CHOLECYSTECTOMY. PAIN IS ASSESSED BY VAS SCORE T0-IMMEDIATE POST OPERATIVE T1-HOURLY TILL 4 HOURS T2-EVERY 4TH HOURLY UPTO 12 HOURS. T3-EVERY 6TH HOURLY UPTO 24 HOURS. IF VAS SCORE.3 RESCUE ANALGESIA 50MG WILL BE GIVEN. |