Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

Not Applicable

• Conditions: Recruitment; Pneumoperitoneum; Postoperative Pain
• Interventions: Procedure: Pulmonary recruitment; Procedure: No pulmonary recruitment

• Registration Number: NCT03069586
• Lead Sponsor: General Hospital Groeninge

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-02-10
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Primary Completion: 2017-03
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• ASA I and II

Exclusion Criteria

• refusal to give consent
• cholecystitis
• BMI above 35
• intolerance to one of the pain medication
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low pressure peritoneum and pulmonary recruitment	Pulmonary recruitment	Surgery on low pressure pneumoperitoneum (8 - 10 mmHg) and at the end of surgery a manual pulmonary recruitment manoeuver (2 x 5sec max 40cmH2O) will be done
Low pressure pneumoperitoneum	No pulmonary recruitment	Surgery on low pressure pneumoperitoneum (8 - 10 mmHg).

Primary Outcome Measures

Name	Time	Method
pain relief during the first 24 hours	24hours	VAS (0-10)

Secondary Outcome Measures

Name	Time	Method
Total analgesic use during the first 24 hours	24hours
Length of hospital stay	2 days
Recovery after 48 hours	48 hours	quality of recovery scale

Trial Locations

Locations (1)

AZ groeninge; 🇧🇪 Kortrijk, Belgium