Comparison Between Low Pressure Pneumoperitoneum with High Pressure Pneumoperitoneum in Post-operative Pain, Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorGulab Devi Hospital

About this trial

This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of pain and common bile duct injuries in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum versus high pressure pneumoperitoneum.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients from both genders

Patients undergoing laparoscopic cholecystectomy for cholelithiasis.

Disqualifiers

Patients with cardiac abnormalities.

Patients with previous abdominal surgeries.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Changing pressure of Pneumoperitoneum to 6-10 mmHg

    Device

    Result of changing pneumoperitoneum pressure on CBD injury and pain

  • Changing pressure of Pneumoperitoneum to 12-15 mmHg

    Device

    Result of changing pneumoperitoneum pressure on CBD injury and pain

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Low Pressure PneumoperitoneumOther 1 intervention
Group B: High Pressure PneumoperitoneumOther 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of pain and common bile duct injury in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum is less versus High pressure pneumoperitoneum.

Pain will accessed using VAS. Pain (VAS): The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). It was assessed at 4, 8, 12 hours post-operatively by using Visual Analogue Pain Scale. No pain \|0\_\_\_\_1\_\_\_\_2\_\_\_\_3\_\_\_\_4\_\_\_\_5\_\_\_\_6\_\_\_\_7\_\_\_\_8\_\_\_\_9\_\_\_\_10\| sever pain Mild pain-Moderate Pain-Sever pain Visual Analogue Pain Scale And CBD injury will be accessed using bismuth classification. CBD INJURY: Injury to CBD Is Classified According to Bismuth Classification: Type I is a low injury with a stump length more than 2 cm. Type II is a middle level injury with a stump length less than 2 cm. Type III is a high-level injury without common hepatic duct available but preserved confluence. Type IV involves loss of hepatic confluence with no communication between right and left ducts.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Gulab Devi Hospital

Lead sponsor

University of Health Sciences Lahore

Sponsor institution