Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

NCT ID: NCT03069586

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-04-30

Brief Summary

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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

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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).

Conditions

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Pneumoperitoneum Recruitment Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Low pressure pneumoperitoneum

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

Group Type OTHER

No pulmonary recruitment

Intervention Type PROCEDURE

At the end of surgery no intervention was completed

low pressure peritoneum and 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

Group Type ACTIVE_COMPARATOR

Pulmonary recruitment

Intervention Type PROCEDURE

At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt

Interventions

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Pulmonary recruitment

At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt

Intervention Type PROCEDURE

No pulmonary recruitment

At the end of surgery no intervention was completed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I and II

Exclusion Criteria

* refusal to give consent
* cholecystitis
* BMI above 35
* intolerance to one of the pain medication
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital Groeninge

OTHER

Sponsor Role lead

Responsible Party

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Casier Isabelle

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AZ groeninge

Kortrijk, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Isabelle Casier

Role: primary

Other Identifiers

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AZGS2014160

Identifier Type: -

Identifier Source: org_study_id

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