- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03069586
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
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Two groups:
- A cholecystectomy at a low pressure pneumoperitoneum (8-10 mmHg)
- 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
-
-
-
Kortrijk, Belgium, 8500
- Recruiting
- AZ Groeninge
-
Contact:
- Isabelle Casier
- Email: isabelle.casier@azgroeninge.be
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZGS2014160
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.
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