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

M

Mahidol University

Status

Unknown

Conditions

Pain, Postoperative

Treatments

Procedure: Intraabdominal pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT04212936
MURA2019/1005

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age > 15 years
  2. Elective procedure of laparoscopic cholecystectomy
  3. Sign to Inform consent

Exclusion criteria

  1. Emergency surgery
  2. Concomitant other procedure performed
  3. Deny to participant

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

84 participants in 2 patient groups

Control group
No Intervention group
Description:
8 mmHg pressure group
Study group
Experimental group
Description:
10 mmHg group
Treatment:
Procedure: Intraabdominal pressure

Trial contacts and locations

1

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Central trial contact

Thanida Janbavonkij, M.D.; Narongsak Rungsakulkij, M.D.

Data sourced from clinicaltrials.gov

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