NCT04212936

Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy

Status unknown NA Last updated 25 February 2021

What this trial tests

NA trial testing Intraabdominal pressure in Pain, Postoperative in 84 participants. Status unknown.

Timeline

25 December 2019

Primary endpoint
31 December 2021

30 June 2022

Quick facts

Lead sponsor	Mahidol University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	84
Start date	25 December 2019
Primary completion	31 December 2021
Estimated completion	30 June 2022
Sites	1 location across Thailand

Drugs / interventions tested

• Intraabdominal pressure

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Mahidol University

Who can join

15 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (\<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. However, there are some postoperative morbidity including shoulder-tip pain. The incidence of shoulder-tip pain is about 15-45%, which might be influencing the patient outcome including length of hospital stay. From the previous studies, one of the important factor associated with this condition is pneumoperitoneum pressure. Thus, the suggestion of the intra-abdominal pressure should be low pressure as about 8 mmHg. However, the optimum pressure for the low-pressure during laparoscopic cholecystectomy is controversial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.