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

  • STATUS
    Recruiting
  • days left to enroll
    37
  • participants needed
    84
  • sponsor
    Mahidol University
Updated on 5 March 2021
cholecystectomy

Summary

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.

Description

We designed the prospective randomized controlled trial to comparing the postoperative shoulder tip pain between two low pressure level (8 and 10 mmHg) during laparoscopic cholecystectomy. After the enrolled participant signed the inform consent, the participant was randomly assigned to 8 or 10 mmHg group. The standard procedure of the laparoscopic cholecystectomy was performed by experience surgeons. During the operation, the pressure limit can be adjusted to facilitate the procedure according to the surgeons. Following the operation, the investigator will ask about the shoulder tip pain from the participant during 48 hours. The standard of care including pain medication during postoperative period was performed.

Details
Condition Postoperative pain, post-operative pain, post-op pain
Treatment Intraabdominal pressure
Clinical Study IdentifierNCT04212936
SponsorMahidol University
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > 15 years
Elective procedure of laparoscopic cholecystectomy
Sign to Inform consent

Exclusion Criteria

Emergency surgery
Concomitant other procedure performed
Deny to participant
Clear my responses

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