| CTRI Number |
CTRI/2024/02/062680 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Pain Relief Methods After Gallbladder Surgery Using Local Injections |
|
Scientific Title of Study
|
Comparative study of analgesic efficacy of preclosure periportal infiltration with that of peritoneal infiltration of local anaesthetics for post operative analgesia in patients undergoing laparoscopic cholecystectomy-A double blind randomised prospective study |
| 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 Ranjini Shome |
| Designation |
Post graduate |
| Affiliation |
MGR UNIVERSITY |
| Address |
Department of Anesthesia, 2nd floor, Rajarajeswari medical college and hospital, No 202, Kambipura Mysore road, Bangalore .
Bangalore
KARNATAKA
560074
India |
| Phone |
9108106959 |
| Fax |
|
| Email |
ranjinishome8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ASHWINI H |
| Designation |
PROFESSOR |
| Affiliation |
MGR UNIVERSITY |
| Address |
Department of Anesthesia, 2nd floor, Rajarajeswari medical college and hospital, No 202, Kambipura Mysore road, Bangalore .
Bangalore
KARNATAKA
560074
India |
| Phone |
8971265579 |
| Fax |
|
| Email |
drashwinih@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjini Shome |
| Designation |
Post graduate |
| Affiliation |
MGR UNIVERSITY |
| Address |
Department of Anesthesia, 2nd floor, Rajarajeswari medical college and hospital, No 202, Kambipura Mysore road, Bangalore .
Bangalore
KARNATAKA
560074
India |
| Phone |
9108106959 |
| Fax |
|
| Email |
ranjinishome8@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJARAJESWARI MEDICAL COLLEGE AND HOPSITAL |
|
|
Primary Sponsor
|
| Name |
DR RANJINI SHOME |
| Address |
Department of Anesthesia , 2nd floor, Rajarajeswari medical college and hospital No 202, Kambipura, Mysore road. Bangalore. |
| 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 Ranjini shome |
Rajarajeswari medical college |
Rajarajeswari medical college and hopsital keneri bangalore -74. Department of Anesthesiology 2nd floor hospital building near modular ot complex.
Bangalore
KARNATAKA |
9108106959
ranjinishome8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laparoscopic cholecystectomy.
Bupivacaine0.25% |
Group A-patients will recieve port site infiltration[local] of 20ml of 0.25% Inj Bupivacaine with 4 mg Inj Dexamethasone.
Group B- patients will recieve intraperitoneal instillation[through the port] od 20ml solution of 0.25% inj Bupivacaine with Inj dexamethasone 4mg in trendelenberg position and will be mainted in the same position for 10 mins. |
| Comparator Agent |
laparoscopic cholecystectomy.
Inj Bupivacaine 0.25% |
INTRAPERITONEAL INFILTRATION.
Group B- patients will ewcieve intraperitoneal infiltration of inj bupivacaine 0.25% +4mh inj dexamethasone . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grades 1 and 2 of either sex.
2.Patients between age group of 20 to 60 years.
3.Undergoing elective laparoscopic cholecystectomy under General anesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with acute cholecystitis.
2. Patients allergic to drug used in the study.
3. Patients who have morbid obesity, choledocholithiasis, patients with chronic pain syndrome, previous upper abdominal surgery, chronic medical disease, chronic opiod treatment.
4. Patients requiring placement of drain postoperatively.
5 Those with stone spillage.
6.Patients in whom conversion to open cholecystectomy was done for any reason |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the analgesic efficacy of periportal and intraperitoneal infiltration of 0.25% Bupivacaine with Dexamethasone 4mg using visual analog scale.
2. to compare total analgesic consumption in first 24 hours.
3.To compare the incidence of adverse effects like shoulder pain , vomiting.
4.To compare degree of ambulation in postoperative period |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare the incidence of adverse effects like shoulder tip pain, vomiting.
To compare the degree of ambulation.
To compare the total analgesic comsumption in first 24 hours. |
24 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy has gained popularity as day care procedure, still patients experience significant pain in early post operative period which may delay discharge. The aim of this study is to compare the analgesic efficacy of periportal and intraperitoneal infiltration of local anesthetic in patients undergoing lap cholecystectomy. To compare the analgesic consumption in first 24 hours. To comapre the incidence of adverse effects like shoulder tip pain and vomiting. To compare the degree of early ambulation . |