CTRI

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CTRI Number

CTRI/2026/01/101333 [Registered on: 16/01/2026] Trial Registered Prospectively

Last Modified On:

15/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of Shoulder Pain After Laparoscopic Gallbladder Surgery Using Low and Standard Gas Pressure

Scientific Title of Study

To evaluate post operative shoulder tip pain in low pressure (less than or equal to 10mmHg CO2) pneumoperitoneum versus standard pressure (13-15 mmHg CO2) pneumoperitoneum in laparoscopic cholecystectomy, a randomized controlled trial 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	Darshan A N
Designation	Junior Resident
Affiliation	Dr Rajendra Prasad Government
Address	Department of General Surgery Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh Kangra HIMACHAL PRADESH 176001 India
Phone	9482470699
Fax
Email	danaik20@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sanjeev Kumar
Designation	Professor and Head of Department
Affiliation	Dr Rajendra Prasad Government
Address	Department of General Surgery Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh Kangra HIMACHAL PRADESH 176001 India
Phone	9418158199
Fax
Email	hodsurgery@rpgmc.ac.in

Details of Contact Person
Public Query

Name	Darshan A N
Designation	Junior Resident
Affiliation	Dr Rajendra Prasad Government
Address	Department of General Surgery Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh Kangra HIMACHAL PRADESH 176001 India
Phone	9482470699
Fax
Email	danaik20@gmail.com

Source of Monetary or Material Support

Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh

Primary Sponsor

Name	Dr Darshan A N
Address	Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh
Type of Sponsor	Other [Self]

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
Darshan A N	Dr Rajendra Prasad Government Medical College	Male Surgery Ward and Female Surgery Ward, Department Of General Surgery, Kangra HIMACHAL PRADESH	9482470699 danaik20@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Dr Rajendra Prasad Government Medical College(Dr. RPGMC) Kangra at Tanda, Himachal Pradesh, India - 176001	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K802\|\|Calculus of gallbladder without cholecystitis,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Low Pressure Pneumoperitoneum (less than or equal to 10 mmHg)	Carbon dioxide gas is infused into abdominal cavity through Veeres needle or trocar to create create and maintain pneumoperitoneum at low pressure (less than or equal to 10 mmHg) which is maintained throughout surgery and gas is drained at the end of surgery.
Intervention	Standard Pressure pneumoperitoneum (13 to 15 mmHg)	Carbon dioxide gas is infused into abdominal cavity through Veeres needle or trocar to create create and maintain pneumoperitoneum at standard pressure (13 to 15 mmHg) which is maintained throughout surgery and gas is drained at the end of surgery.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Individuals aged 18 years and older and undergoing elective Laparoscopic Cholecystectomy. Participants represent various age group and gender. They are capable of expressing pain and have sufficient language and communication skills to provide informed consent and complete assessments.

ExclusionCriteria

Details

1.Conversion to open cholecystectomy
2.Acute inflammation or any other complication of gall stone disease.
3.Choledocholithiasis
4.Any intra-operative or post-operative complication such as bile duct injury, bile duct obstruction, intra-operative discovery of bile duct anomalies, infection and fever.
5. Substance Abuse: Exclude individuals with a history of substance abuse or dependence, as substance use may impact pain tolerance.
6. Patient Post operatively shifted to ICU and High Dependency Unit.
7. Inability to Provide Informed Consent: Exclude individuals who are unable to provide informed consent due to cognitive impairment or other reasons, as they may not fully understand the study procedures or risks involved.
8. Patients with significant portal hypertension, coagulopathies, suspected gall bladder carcinoma, cirrhosis or generalised peritonitis.

Method of Generating Random Sequence

Other

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Evaluate the incidence of shoulder tip pain in normal pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy	Shoulder tip pain is evaluated at 1 hour, 6 hour, 12 hour, 24 hour, 72 hour and 1 week after surgery

Secondary Outcome

Outcome	TimePoints
Evaluate the incidence of shoulder tip pain in patient of Laparoscopic cholecystectomy.	Evaluate the incidence of shoulder tip pain in normal pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy
Compare relationship between pneumoperitoneum pressure and post operative shoulder tip pain	Evaluate the incidence of shoulder tip pain in normal pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100"

Phase of Trial

N/A

Date of First Enrollment (India)

26/01/2026

Date of Study Completion (India)

31/03/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

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

Laparoscopic cholecystectomy, is one of the most frequently performed abdominal operations. During this procedure, carbon dioxide gas is used to inflate the abdomen to create space for surgery. Although minimally invasive, many patients experience post-operative shoulder pain, which can cause discomfort, delay mobilization, and increase the need for pain medications. This shoulder pain is believed to occur due to irritation of the diaphragm caused by the gas used during surgery.

Traditionally, laparoscopic cholecystectomy is performed using standard gas pressure. However, recent studies suggest that using a lower gas pressure may reduce post-operative shoulder pain without affecting the safety or effectiveness of the surgery.

This randomized controlled trial aims to compare post-operative shoulder pain in patients undergoing laparoscopic cholecystectomy using low gas pressure (less than or equal to 10 mmHg) versus standard gas pressure (13–15 mmHg). Eligible patients will be randomly assigned to one of the two groups. Shoulder pain severity will be assessed using a standardized pain scale at regular intervals after surgery. Other outcomes such as overall pain, need for pain medication, duration of surgery, and any complications will also be recorded.

The findings of this study may help identify a simple and cost-effective method to improve patient comfort after laparoscopic gallbladder surgery without compromising surgical safety.