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

Pain, Postoperative Clinical Trial

Official title:

Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy, a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212936
• Other study ID #: MURA2019/1005
• Status: Recruiting
• Phase: N/A
• Start date: December 25, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2021
• Source: Mahidol University
• Contact: Thanida Janbavonkij, M.D.
• Phone: (660)909851540
• Email: Than_bow[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Intraabdominal pressure
Limited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder tip pain	The shoulder tip pain was assessed by the investigator during postoperative period unfil 48 hours. The measurement of the outcome, the investigator would ask the participant by the clinical record form and questionnair. The answer of the questionnaire is presence or absence of the shoulder pain or pain around the shoulder and scapular region.	48 hours
Secondary	Change of intra-abdominal pressure	The change of intra-abminal pressure was measure by two parameters. Firstly, the adjustment of the pressure during the operation was recorded by the questionnaire. The answer of the questionnaire is the presence or absence of the intra-abdominal pressure change. Secondly, the maximum intra-abdominal pressure which is the highest pressure used during the operation, is measure by the level of the pressure appearing in the laparoscopic station by mmHg unit.	Immediately after surgery
Secondary	Difficulty of the operation	The difficulty level of the operation which evaluated by the surgeons. The measurement of this outcome by the questionnaire.	Immediately after surgery