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Assessment of shoulder pain following laparoscopic cholecystectomy under standard or low intra-abdominal gas pressure

IMPACT OF STANDARD PRESSURE AND LOW PRESSURE PNEUMOPERITONEUM IN SHOULDER PAIN FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY: A DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/02/006590
Enrollment
80
Registered
2016-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients undergoing laparoscopic cholecystectomy

Interventions

Intervention1: Laparoscopic cholecystectomy performed under standard pressure and low pressure pneumoperitoneum: Standard pressure pneumoperitoneum defined as cabondioxide pneumoperitoneum of 14mm Hg

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria All consecutive patients (adult male and females > 18 and Exclusion Criteria 1. ASA grade IV and V 2. BMI >30 kg/m2. 3. history of ERCP and stent in situ. 4. known shoulder disease 5. history of acute cholecystitis, cholangitis and pancrreatitis 6. history of multiple abdominal surgery 7. uncorrectable coagualopathy 8. significant co-morbidities like coronary artery disease, asthma, COPD, and previous malignancy. 9. Patients requiring other concomitant procedures. 10. Patients who do not give consent for participation in the study or patient with cognitive impairments 11. Patients on chronic analgesic use

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. ASA grade IV and V 2. BMI >30 kg/m2. 3. history of ERCP and stent in situ. 4. known shoulder disease 5. history of acute cholecystitis, cholangitis and pancrreatitis 6. history of multiple abdominal surgery 7. uncorrectable coagualopathy 8. significant co-morbidities like coronary artery disease, asthma, COPD, and previous malignancy. 9. Patients requiring other concomitant procedures. 10. Patients who do not give consent for participation in the study or patient with cognitive impairments 11. Patients on chronic analgesic use

Design outcomes

Primary

MeasureTime frame
Incidence and severity of shoulder pain on Visual Analogue ScaleTimepoint: 4, 8, 24 hours and 7 days after Laparoscopic Cholecystectomy—

Secondary

MeasureTime frame
1. Duration of surgery 2. Surgeons satisfaction score 3. Technical difficulty 4. Abdominal pain on VAS score 5. Intra-operative changes in heart rate and blood pressure Timepoint: Abdominal pain is measured by VAS at 4, 8, 24 hours and 7 days after laparoscopic cholecystectomy Intra operative changes in heart rate and blood pressure at every five minutes interval—

Countries

India

Contacts

Public ContactHemanga K Bhattacharjee

All India Institute of Medical Sciences, New Delhi

azrudn@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 12, 2026