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CTRI Number  CTRI/2026/01/102161 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 24/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of negative aspiration of pneumoperitoneum over shoulder tip pain during laparoscopic removal of gallbladder : Randomized Control Trial Study 
Scientific Title of Study   Effect of active aspiration of pneumoperitoneum on shoulder-tip pain following laparoscopic cholecystectomy: a randomized controlled 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 Mahendra Legha  
Designation  Junior Resident Academic 
Affiliation  AIIMS Deoghar 
Address  Department of General Surgery AIIMS Deoghar Jharkhand India

Deoghar
JHARKHAND
814152
India 
Phone  8742837462  
Fax    
Email  mahendralegha1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhinav Prakash Arya 
Designation  Associate Professor  
Affiliation  AIIMS Deoghar 
Address  Department of General Surgery AIIMS Deoghar Jharkhand India

Deoghar
JHARKHAND
814152
India 
Phone  8601364363  
Fax    
Email  abhinavapa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhinav Prakash Arya 
Designation  Associate Professor  
Affiliation  AIIMS Deoghar 
Address  Department of General Surgery AIIMS Deoghar Jharkhand India

Deoghar
JHARKHAND
814152
India 
Phone  8601364363  
Fax    
Email  abhinavapa@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery AIIMS Deoghar JHARKHAND 
 
Primary Sponsor  
Name  Department of General Surgery AIIMS Deoghar 
Address  Department of General Surgery AIIMS Deoghar Jharkhand 814152 
Type of Sponsor  Government 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 Mahendra Legha  AIIMS Deoghar  Department of General Surgery AIIMS Deoghar Jharkhand 814152
Deoghar
JHARKHAND 		 8742837462

mahendralegha1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
18th IEC Sub-Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effect of active aspiration of pneumoperitoneum on shoulder-tip pain following laparoscopic cholecystectomy  Following completion of the laparoscopic cholecystectomy,in the treatment group, the suction canula will be inserted while putting the patient in Trendelenburg position and the pneumoperitoneum will be actively aspirated till complete obliteration of laparoscopic view. In the post-operative period, right shoulder pain and abdominal pain will be noted using Visual Analogue Scale (VAS) at 4 hourly ± SOS for Next 48 hours post-operatively.  
Comparator Agent  Patient undergoing passive aspiration of pneumoperitoneum  Following completion of the cholecystectomy, in the control group, the valves of the ports will be opened to allow passive escape of the pneumoperitoneum.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients with chronic calculous cholecystitis of American Society of Anesthesiology Grade (ASA) 1 or 2 
 
ExclusionCriteria 
Details  All Previous abdominal surgery
Patient getting converted from laparoscopic to open surgery intraoperatively.
Patient receiving abdominal drains post operatively.
Pregnant patients
Patients with acute or acute on chronic calculous cholecystitis.
Patient unfit for pneumoperitoneum.
Active Sepsis or Coagulopathy.
Patient not able to understand the visual analogue scale
Patient not consenting for surgery
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the difference in the shoulder pain and abdominal pain scores between the passive (control) and active (intervention) pneumoperitoneum-aspiration groups.  In the post-operative period, right shoulder pain and abdominal pain will be noted using Visual Analogue Scale (VAS) at 4 hourly ± SOS for Next 48 hours post-operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the difference between analgesic requirements in between the two groups.  Patients of both groups will receive 12 hourly analgesia of intravenous (IV) diclofenac sodium injection (75 mg) for first 24 hour followed by as per need analgesia after 24 hours. In this period of 48 hours, patient may receive additional analgesics if needed (75 mg IV diclofenac sodium injection or IV paracetamol 1 gram ± 50 mg intramuscular (IM) Tramadol) by the patient on SOS basis. Total dose and the types of analgesics given will be noted for each patient for this 48-hour duration.  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   17/02/2026 
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="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  

Eligible patients undergoing laparoscopic cholecystectomy will be randomized into two groups: a control group with passive release of surgical gas and a treatment group with active suction of gas at the end of surgery. All patients will undergo standard four-port laparoscopic cholecystectomy under standard general anesthesia. Carbon dioxide will be used to create pneumoperitoneum and total gas usage will be recorded. Postoperatively, shoulder tip pain and abdominal pain will be assessed using the Visual Analogue Scale at regular intervals of 4 hour for 48 hours.  

 
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