Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

General Hospital Groeninge

Status: Unknown

Conditions: Postoperative Pain; Recruitment; Pneumoperitoneum

Treatments: Procedure: Pulmonary recruitment; Procedure: No pulmonary recruitment

Study type: Interventional

Funder types: Other

Identifiers

NCT03069586

AZGS2014160

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I and II

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Low pressure pneumoperitoneum

Other group

Description:

Surgery on low pressure pneumoperitoneum (8 - 10 mmHg).

Treatment:

Procedure: No pulmonary recruitment

low pressure peritoneum and pulmonary recruitment

Active Comparator group

Description:

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

Treatment:

Procedure: Pulmonary recruitment