| CTRI Number |
CTRI/2024/08/072728 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
The impact of intraperitoneal normal saline instillation on reducing shoulder tip pain after laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Effectiveness of intraperitoneal instillation of normal saline in reducing shoulder tip pain following laparoscopic cholecystectomy. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| aanshul42@gmail.com |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshul |
| Designation |
PG JR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL CHANDIGARH |
| Address |
Government medical college and hospital sector 32 Chandigarh Department of general surgery
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8837885423 |
| Fax |
|
| Email |
aanshul42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Bansiwal |
| Designation |
Professor |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL CHANDIGARH |
| Address |
Government medical college and hospital sector 32 Chandigarh Department of general surgery
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8837885423 |
| Fax |
|
| Email |
rajbansiwal_72@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Anshul |
| Designation |
PG JR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL CHANDIGARH |
| Address |
Government medical college and hospital sector 32 Chandigarh Department of General surgery
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8837885423 |
| Fax |
|
| Email |
generalsurgery.chd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital sector 32 Chandigarh |
|
|
Primary Sponsor
|
| Name |
Anshul |
| Address |
Government medical college and hospital sector 32 Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
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 ANSHUL |
Government medical college and hospital |
Department of general surgery D block 2nd floor
Chandigarh
CHANDIGARH |
8837885423
aanshul42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraperitoneal instillation of normal saline post laparoscopic cholecystectomy. |
VAS score is used to assess the incidence of post-procedure shoulder tip pain at 6, 12, 24 and 48h after elective laparoscopic cholecystectomy. |
| Comparator Agent |
No intraperitoneal saline given |
VAS score is used to assess the incidence of post-procedure shoulder tip pain at 6, 12, 24 and 48h after elective laparoscopic cholecystectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 and 65 years of age with an American Society of Anesthesiologists physical status classification of I-II (ASA classification) who are scheduled to undergo an elective laparoscopic cholecystectomy can participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Conversion to open cholecystectomy
2. Patients in whom abdominal drain have been put after laparoscopic cholecystectomy.
3. Pre-existing shoulder pain which is based on doctor evaluation and clinical report before the study.
4. Pre-existing liver disease
5. Any biliary spillage in control group.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the incidence of post-procedure shoulder tip pain at 6, 12, 24 and 48h after elective laparoscopic cholecystectomy. |
1. To assess the incidence of post-procedure shoulder tip pain at 6, 12, 24 and 48h after elective laparoscopic cholecystectomy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To determine role of intraperitoneal instillation of normal saline in reducing severity of post laparoscopic shoulder tip pain. |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 |
|
Date of First Enrollment (India)
|
24/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patient who are found fit in preanesthetic checkup will be posted for laparoscopic cholecystectomy. Laparoscopiccholecystectomy will be performed after creating pneumoperitoneum with carbon dioxide insufflation under standard pressure of 12 mmHg. After removing gall bladder as per standard surgical technique patient in the intervention group will receive intraperitoneal instillation of normal saline at body temperature in the right hemidiaphragmaticarea until the whole liver is submerged. After irrigating, whole of intraperitoneal fluid in group A will be evacuated by negative suction drainage whereas in other group no such instillation of normal saline will be done. After performing the procedure all port site will be closed. Patient where drain has been put will be excluded from the study. After performing procedure right shoulder tip pain will be assessed at 6, 12, 24 and 48h using visual analogue scale (VAS). In which pain intensity score of 0 represents no pain, 1-3 mild pain , 4-6 moderate pain, 7-10 indicates severe pain23. The pain scores using VAS will be entered on patient’s proforma. Both the patient and observer willbe blinded to the type of intervention the
patient has received. Data will be recorded concerning duration of surgery, bile spillage during operation, frequencyand intensity of shoulder-tip pain. |