| CTRI Number |
CTRI/2019/07/020429 [Registered on: 29/07/2019] Trial Registered Prospectively |
| Last Modified On: |
13/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of injection Bupivacaine(0.25%) into abdominal cavity for postoperative pain relief following Laparoscopic cholecystectomy |
|
Scientific Title of Study
|
To study the effect of instillation of intraperitoneal Bupivacaine (0.25%) to achieve postoperative analgesia in patients undergoing 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 |
Dr Avinash Banjare |
| Designation |
PG Student |
| Affiliation |
Pt J N M Medical college, Raipur (C.G.) |
| Address |
Department of Anaesthesiology and Critical care
Pt J N M Medical College, Raipur
Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8120507490 |
| Fax |
|
| Email |
banjare.avinash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
Professor & HOD |
| Affiliation |
Pt J N M Medical College, Raipur, (C.G.) |
| Address |
Department of Anaesthesiology and Critical care
Pt J N M Medical College, Raipur
Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
|
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avinash Banjare |
| Designation |
PG Student |
| Affiliation |
Pt J N M Medical College |
| Address |
Department of Anaesthesiology and Critical care
Pt J N M Medical College, Raipur
Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8120507490 |
| Fax |
|
| Email |
banjare.avinash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Avinash Banjare
PG RESIDENT Department of anaesthesiology and crtical care
Pt J N M Medical College and Dr BRAM Hospital, Raipur. (C. G.) |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology and crtical care |
| Address |
Department of Anaesthesiology and Critical care
Pt J N M Medical College, Raipur
Chhattisgarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Avinash Banjare |
Pt J N M Medical College and Dr B R A M hospital, Raipur |
Department of anaesthesiology and critical care
Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH |
8120507490
banjare.avinash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt JNM Medical College Raipur (C. G) |
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 |
| Intervention |
Instillation of intraperitoneal Bupivacaine (0.25%) 40ml in Patients undergoing laparoscopic cholecystectomy. |
Bupivacaine (0.25%).
Intraperitoneal Instillation in the sub diaphragmatic suprahepatic surface of liver and gall bladder fossa.
Dose is 40ml of 0.5%.
Frequency is single dose of bolus.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I-II
Age 18 – 60 years
Weight 45-85Kg
A patient undergoing Laparoscopic Cholecystectomy under General Anaesthesia. |
|
| ExclusionCriteria |
| Details |
Needing bile duct exploration, insertion of a T-drain.
Acute cholecystitis.
Surgery-related complication example, bile spillage or conversion to open cholecystectomy
Duration of surgery exceeded 2 hours.
Severe systemic disease.
Prolong Analgesics ingestion
Allergy to local anesthetics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients having Visual Analog Score(VAS)3 at 3hours |
Proportion of patients having Visual Analog Score(VAS)3 at 3hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia
Haemodynamic Variables such as Heart Rate (HR), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
24 hours analgesia requirement
Sideeffects such as Post Operative nausea, vomiting and respiratory depression |
every 2 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/08/2019 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
My Thesis is to study the effect of instillation of intraperitoneal Bupivacaine (0.25%) to achieve postoperative analgesia in 50 patients undergoing Laparoscopic Cholecystectomy. Patients belonging to ASA grade I-II, aged 18year to 60years, weighing between 45-85 Kgs, undergoing Laparoscopic Cholecystectomy under General Anaesthesia are selected for the study. After removal of gallbladder and haemostasis achieved, residual blood and fluid will be thoroughly suctioned. The surgeon will instill 40ml of 0.25% Bupivacaine in the subdiaphragmatic suprahepatic surface of liver and gall bladder. In the postoperative period, we observe the duration of analgesia using Visual Analog Score, hemodynamic variables, 24 hours analgesic requirement, and any side effects. |