FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/099747 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Patientcame for laparoscopic cholecystectomy and we used Intraperitonial nebulisation in one group and Intraperitonial instillation in another with Ropivacaine for post operative pain management in patients undergoing laparoscopic cholecystectomy under general anaesthesia . 
Scientific Title of Study   Comparison of efficacy of Intraperitonial nebulisation versus Intraperitonial instillation of Ropivacaine for post operative pain management in patients undergoing laparoscopic cholecystectomy under general anaesthesia . 
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 Riya bishnoi 
Designation  Resident  
Affiliation  Mahatma Gandhi Medical College And Hospital 
Address  OT complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur, Rajasthan Jaipur RAJASTHAN 302022 India

Jaipur
RAJASTHAN
302022
India 
Phone  8114403323  
Fax    
Email  riyabishnoi236@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Khayyam  
Designation  Professor  
Affiliation  Mahatma Gandhi Medical Hospital  
Address  OT complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur, Rajasthan Jaipur RAJASTHAN 302022 India

Jaipur
RAJASTHAN
302022
India 
Phone  9468964148  
Fax    
Email  drkhyayyam@mgumst.org  
 
Details of Contact Person
Public Query
 
Name  Dr Khayyam  
Designation  Professor  
Affiliation  Mahatma Gandhi Medical Hospital  
Address  OT complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur, Rajasthan Jaipur RAJASTHAN 302022 India


RAJASTHAN
302022
India 
Phone  9468964148  
Fax    
Email  drkhyayyam@mgumst.org  
 
Source of Monetary or Material Support  
India educational trust, department of anesthesiology and critical care, Mahatma Gandhi medical college and hospital, Ricco industrial area, sitapura, tonk road, jaipur, Rajasthan, India , 302022 
 
Primary Sponsor  
Name  India educational trustdepartment of anesthesiaMahatma Gandhi medical college and hospital 
Address  RIICO industrial area, sitapura, tonk road, jaipur, Rajasthan, India, 302022 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Riya Bishnoi   Mahatma Gandhi medical college and hospital  Department of anesthesia and critical care, Mahatma Gandhi medical college and hospital, RICCO industrial area, sitapura, Ramchandrapura, jaipur, Rajasthan, India, 302022 Jaipur RAJASTHAN
Jaipur
RAJASTHAN 
8114403323

riyabishnoi236@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Institutional Ethics Committee Mahatma Gandhi Medical College & Hospital Mahatma Gandhi University of Medical Sciences & Technology Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intraperitoneal instillation   Intraperitoneal mist instillation with Ropivacaine 0.5% 20ml using the Aerogen Pro® device 
Intervention  Intraperitonial nebulisation  In intraperitoneal instillation 20 mL of 0.5 % of ropivacaine will be injected through the umbilical port before removal of the trocars 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 18–60 years
ASA (American Society of Anaesthesiologists) physical status I and II
Undergoing elective laparoscopic cholecystectomy under general anaesthesia
Willing to provide informed consent
 
 
ExclusionCriteria 
Details  Known allergy or hypersensitivity to local anesthetics
Chronic opioid use or chronic pain conditions
Conversion to open surgery
Pregnancy or lactation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of efficacy of Intraperitonial nebulisation versus Intraperitonial instillation of Ropivacaine for post operative pain management in patients undergoing laparoscopic cholecystectomy under general anaesthesia  Pain Assessment: Using the Numeric Rating Scale (NRS) at 0, 2, 6, 12, and 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the Postoperative pain scores at rest and on movement (static and dynamic) as
per Numeric Rating Scale (NRS)
2. To assess the time Of first rescue analgesia
3. Total 24 hrs analgesic consumption
4. Incidence of shoulder pain
5.Determine the overall patient satisfaction and recovery profile in both study groups
6. Surgeon satisfaction
Rationale of why a human study is neede 
Pain Assessment: Using the Numeric Rating Scale (NRS) at 0, 2, 6, 12, and 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   02/02/2026 
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 is the preferred approach for gallbladder removal as it is

minimally invasive procedure and associated with many advantages over open surgery [1].

 .Although laparoscopic surgeries are associated with reduced postoperative pain, reduced hospital

stay and faster recovery compared to open procedures, still patients often experience significant

discomfort and pain especially in the early postoperative period. Effective management of

postoperative pain is crucial not only for patient-comfort but also for reducing the risk of

complications, enhancing recovery, and facilitating early discharge. [2].

 Pain experienced after laparoscopic cholecystectomy is mainly felt due to intraperitonial

insufflation of carbon dioxide resulting in the peritoneal stretching and Somatic pain from trocar

sites. shoulder pain resulting from diaphragmatic irritation due to retention of CO2

pneumoperitoneum is commonly observed postoperative period [4]

Administration of intraperitoneal local anasthetic in laparoscopic surgeries as part of a multimodal

approach to post op-Operative pain management is safe, but intraperitoneal instillation provides

limited pain relief [4]. Failure to achieve adequate pain-relief after intraperitoneal local anaesthetic

instillation may be attributed to the non-uniform distribution of local Anaesthetic throughout the

peritoneal surface [5]

 Intraperitoneal mist instillation, a novel technique for drug administration, aims to achieve

uniform dispersion of local anaesthetic particles measuring 0.3 microns throughout the

peritoneal cavity. This procedure involves utilising the Aerogen Pro® device, which is

connected between the insufflator and the insufflation tubing. Tubing is then attached to the

umbilical port. The initiation of mist instillation coincides with the commencement of

laparoscopic gas insufflation, ensuring simultaneous and efficient dispersion of the

local anaesthetic particles.

 Intraperitoneal mist instillation of Ropivacaine offers benefits such as reduced opioid

consumption, improved pain control, and faster recovery compared to traditional pain

management methods alone.

This randomised controlled trial aims to compare the efficacy of intraperitonial ropivacaine instillation

and intraperitonial ropivacaine nebulisation with aerogen pro device in laparoscopic

cholecystectomy.

Thus, we have designed a double blinded study and hypothesised that Intraperitoneal mist

instillation of Ropivacaine may offer better postoperative analgesia as compared to Intraperitonial

instillation


 
Close