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

NCT ID: NCT04212936

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-25
• Study Completion Date: 2022-06-30

Brief 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.

Detailed 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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

8 mmHg pressure group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study group

10 mmHg group

Group Type: EXPERIMENTAL

Intraabdominal pressure

Intervention Type: PROCEDURE

Limited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg.

Interventions

Intraabdominal pressure

Limited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Narongsak Rungsakulkij

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Narongsak Rungsakulkij, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

Locations

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Thanida Janbavonkij, M.D.

Role: CONTACT

Than_bow@hotmail.com

(660)909851540

Narongsak Rungsakulkij, M.D.

Role: CONTACT

narongsak.run@mahidol.ac.th

(660)22011527

Facility Contacts

Narongsak Rungsakulkij, M.D.

Role: primary

narongsak.run@mahidol.ac.th

(660)2011527

Thanida Janbavonkij, M.D.

Role: backup

Than_bow@hotmail.com

(660)909851540

Other Identifiers

MURA2019/1005

Identifier Type: -

Identifier Source: org_study_id