| CTRI Number |
CTRI/2025/06/089403 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
POSTOPERATIVE PAIN ASSESSMENT BY DOING ACTIVE GAS SUCTIONING IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS |
|
Scientific Title of Study
|
EFFECT OF ACTIVE GAS SUCTIONING IN POSTOPERATIVE PAIN MANAGEMENT AFTER LAPAROSCOPIC CHOLECYSTECTOMY : A PROSPECTIVE OBSERVATIONAL 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 TRISHLA JAIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL SURGERY KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE
Belgaum
KARNATAKA
590010
India |
| Phone |
8073703455 |
| Fax |
|
| Email |
trishlajain94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. VISHWANATH M. PATTANSHETTI |
| Designation |
PROFESSOR |
| Affiliation |
KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL SURGERY KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE
Belgaum
KARNATAKA
590010
India |
| Phone |
9886175471 |
| Fax |
|
| Email |
viceprincipaldrvmp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR. VISHWANATH M. PATTANSHETTI |
| Designation |
PROFESSOR |
| Affiliation |
KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL SURGERY KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE
Belgaum
KARNATAKA
590010
India |
| Phone |
9886175471 |
| Fax |
|
| Email |
viceprincipaldrvmp@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF GENERAL SURGERY , KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE , BELGAUM , KARNATAKA, 590010 , INDIA |
|
|
Primary Sponsor
|
| Name |
DR TRISHLA JAIN |
| Address |
DEPARTMENT OF GENERAL SURGERY KLE JAWAHARLAL NEHRU MEDICAL COLLEGE, BELGAUM - KARNATAKA 590010 , INDIA |
| Type of Sponsor |
Other [PRIMARY INVESTIGATOR] |
|
|
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 TRISHLA JAIN |
KLEs Dr. Prabhakar Kore Hospital and Medical research Centre |
Department Of General Surgery , KLE Jawaharlal Nehru Medical College
Belgaum
KARNATAKA |
8073703455
trishlajain94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE,JAWAHARLAL NEHRU MEDICAL COLLEGE,KLE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH SYMPTOMATIC GALL STONES , GALLBLADDER POLYP , ADENOMYOMATOSIS OR PORCELAIN GALL BLADDER
PATIENTS WITH GALLBLADDER STONE AND CBD STONE WHERE CBD STONE HAVE BEEN REMOVED BY ERCP
PATIENTS PROVIDING DUE CONSENT FOR STUDY |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH COMPLICATION 0F GALLSTONE DISEASE , EMPYMEA , OBSTRUCTIVE JAUNDICE
LAPAROSCOPIC PROCEDURE CONVERTED TO OPEN CHOLECYSTECTOMY
HISTORY OF UPPER ABDOMINAL SURGERY
REQUIRING DRAIN AFTER SURGERY
PATIENTS WITH COAGULOPATHY. PORTAL HYPERTENSION , PREGNANCY , ABNORMAL LFT ,UNFIT FOR ANESTHESIA |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| DECREASED PAIN IN ABDOMEN AND SHOULDER TIP PAIN IN PATIENTS WHERE INTRAPERITONEAL GAS SUCTIONING IS PERFORMED |
POSTOPERATIVE 6 HOURS AND POSTOPERATIVE DAY 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DECREASED USE OF ANALGESIC DRUGS POSTOPERATIVELY |
EARLY RESUMPTION OF DAILY ACTIVITIES |
|
|
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)
|
05/07/2025 |
| 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
|
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 RELIES ON ESTABLISHMENT OF PNEUMOPERITONEUM : WHERE THE PERITONEAL CAVITY IS FILLED WITH CO2 TO FACILITATE THE OPERATIVE PROCEDURE WHICH IN TURN LEAD TO COMPLICATIONS LIKE PAIN IN ABDOMEN AND SHOULDER TIP PAIN DUE TO OVERSTRECHING OF DIAPHRAGM MUSCLE . IN THIS STUDY , POSTOPERATIVE PAIN WILL BE EVALUATED IN TWO GROUPS OF PATIENT - ONE GROUP [ CASE ] WHERE INTRAPERITONEAL GAS SUCTIONING IS PERFORMED WITH SECOND GROUP [ CONTROL ] WHERE ITS NOT PERFORMED . |