Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

February 27, 2017 updated by: Casier Isabelle, General Hospital Groeninge

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low pressure pneumoperitoneum
Surgery on low pressure pneumoperitoneum (8 - 10 mmHg).
At the end of surgery no intervention was completed
Active Comparator: 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
At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain relief during the first 24 hours
Time Frame: 24hours
VAS (0-10)
24hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total analgesic use during the first 24 hours
Time Frame: 24hours
24hours
Length of hospital stay
Time Frame: 2 days
2 days
Recovery after 48 hours
Time Frame: 48 hours
quality of recovery scale
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumoperitoneum

Clinical Trials on No pulmonary recruitment

3
Subscribe