Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

The Effect of Low Pressure Pneumoperitoneum and Pulmonary Recruitment Manoeuvre on Postoperative Pain After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03069586
• Other study ID #: AZGS2014160
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2016
• Last updated: February 27, 2017
• Start date: May 2015
• Est. completion date: April 2017

Study information

• Verified date: February 2017
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain. Therefore the investigators will conduct a prospective randomized controlled, single blind trial.

Description:

Two groups:

1. A cholecystectomy at a low pressure pneumoperitoneum (8-10 mmHg)

2. A cholecystectomy at a lowpressure pneumoperitoneum (8-10mmhg) and at the end a pulmonary recruitment manoeuvre (5 sec at max 40 cmH2O).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA I and II

Exclusion Criteria:

• refusal to give consent

• cholecystitis

• BMI above 35

• intolerance to one of the pain medication

• pregnancy

Related Conditions & MeSH terms

• Pain, Postoperative
• Pneumoperitoneum
• Postoperative Pain
• Recruitment

Intervention

Procedure:
• Pulmonary recruitment
At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt
• No pulmonary recruitment
At the end of surgery no intervention was completed

Locations

Country	Name	City	State
Belgium	AZ groeninge	Kortrijk

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Groeninge

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief during the first 24 hours	VAS (0-10)	24hours
Secondary	Total analgesic use during the first 24 hours		24hours
Secondary	Length of hospital stay		2 days
Secondary	Recovery after 48 hours	quality of recovery scale	48 hours