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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Intraabdominal pressure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thanida Janbavonkij, M.D.; Phone Number: (660)909851540; Email: Than_bow@hotmail.com
• Study Contact Backup: Name: Narongsak Rungsakulkij, M.D.; Phone Number: (660)22011527; Email: narongsak.run@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Faculty of Medicine, Ramathibodi Hospital, Mahidol University
    • Contact: Thanida Janbavonkij, M.D.; Phone Number: (660)909851540; Email: Than_bow@hotmail.com
    • Contact: Narongsak Rungsakulkij, M.D.; Phone Number: (660)2011527; Email: narongsak.run@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 8 mmHg pressure group
Experimental: Study group; 10 mmHg group	Procedure: Intraabdominal pressure; Limited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Narongsak Rungsakulkij, M.D., Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MURA2019/1005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No