| 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
|
|
|
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
|
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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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
|
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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
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