| CTRI Number |
CTRI/2025/07/091472 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess for improvement in pulmonary functions in patients undergoing Lap cholecystectomy after irrigation of gall bladder bed with ropivacaine in comparison to normal saline |
|
Scientific Title of Study
|
Effects of gallbladder bed irrigation with Ropivacaine vs Normal Saline on Pulmonary functions of patients undergoing laparoscopic cholecystectomy. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moksha Joshi |
| Designation |
Junior Resident |
| Affiliation |
Grant Government Medical College and Sir J.J. Group of hospitals |
| Address |
Department of Anaesthesia, JJ Hospital, Mumbai
Raigarh
MAHARASHTRA
400008
India |
| Phone |
9920753424 |
| Fax |
|
| Email |
joshimoksha97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poornima Sonkamble |
| Designation |
Assosciate Professor |
| Affiliation |
Grant Government Medical College |
| Address |
Department of Anaesthesia, Grant Government Medical College, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9850961195 |
| Fax |
|
| Email |
Pathadepoornima@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Moksha Joshi |
| Designation |
Junior Resident |
| Affiliation |
Grant Government Medical College |
| Address |
Department of Anaesthesia, Grant Government Medical College, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9920753424 |
| Fax |
|
| Email |
joshimoksha97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Grant Government Medical College |
|
|
Primary Sponsor
|
| Name |
Moksha Joshi |
| Address |
Grant Government Medical College, 400008, Mumbai, Maharashtra, India |
| 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 Moksha Joshi |
Grant Government Medical College |
Department of Anaesthesia, Grant Governmet Medical college, J J Marg, Nagpada-Mumbai Central, Off Jijabhoy Road, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA |
9920753424
joshimoksha97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GGMC and JJH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline |
gall bladder bed irrigated with normal saline, as done routinrly in Laparoscopic cholecystectomy |
| Intervention |
Ropivacaine
|
The patients will be randomized into two equal groups of 35 patients each.
Group N: Laparoscopic cholecystectomy + Irrigation of gallbladder bed with 20 mL normal saline.
Group R: Laparoscopic cholecystectomy + Irrigation of gallbladder bed with 20 mL 0.5% ropivacaine solution
The primary objective is to compare the postoperative pulmonary function parameters, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and forced expiratory flow at 25-75% (FEF 25-75%) between patients who receive gallbladder bed irrigation with ropivacaine and those who receive normal saline. Pulmonary function tests will be performed preoperatively, and post operatively at 6 hours, 8 hours, 12 hours, and post op day (POD) 1. Forced vital capacity (FVC), forced expiratory volume at 1 s (FEV-1), and forced expiratory flow at 25% to 75% (FEF 25–75%) will be noted. The effect of postoperative pain will also be noted in the form of VAS score.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The patients who were willing to participate in study and had given written, valid and informed consent.
Age - 18-65 years
Patients posted for laparoscopic cholecystectomy
American Society of Anaesthesiologist grade I and II
Patients belonging to either gender
|
|
| ExclusionCriteria |
| Details |
Patient refusal to be part of the study.
Patients with known allergies or contraindications to ropivacaine, the agent used for gallbladder bed irrigation.
Pregnancy or Lactation: Pregnant or lactating patients, as the safety of ropivacaine use during pregnancy and lactation, is not established.
Chronic Respiratory Conditions; Severe Cardiovascular Disease; Severe Liver or kidney disease; acute cholecystitis, choledocholithiasis
History of Allergic Reactions;
Current Medications; Patients currently taking medications that may interact with ropivacaine (eg Fluvoxamine, cimetidine, ciprofloxacin, ketoconazole, verapamil, amiodarone) or affect pulmonary function particularly medications that influence neuromuscular function (eg aminoglycosides, magnesium, or chronic steroids) or respiratory depression (eg Opioids, benzodiazepines, barbiturates)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FEV1, FVC, FEF 25-75 |
Baseline, 6 hours, 8 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale, BHT, SBC, Cough test
|
Baseline, 6hours, 8 hours, 12 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
hypothesis - Gallbladder bed irrigation with ropivacaine, when used as an adjunctive technique during laparoscopic cholecystectomy, will result in improved pulmonary functions compared to standard laparoscopic cholecystectomy without ropivacaine irrigation.
|