PneumoperitoneumNCT03069586
Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain
A study testing Pulmonary recruitment and No pulmonary recruitment in people with Pneumoperitoneum and Recruitment, run by General Hospital Groeninge at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumoperitoneum, Recruitment, Postoperative Pain
- What is being tested?
- Pulmonary recruitment and No pulmonary recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and II
Who cannot join
- refusal to give consent
- cholecystitis
- BMI above 35
- intolerance to one of the pain medication
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ groeninge
Kortrijk, 8500
Isabelle Casier, isabelle.casier@azgroeninge.be
About this study
Official title: 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.
Read the 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).
- Conditions
- Pneumoperitoneum, Recruitment, Postoperative Pain
- Being tested
- Pulmonary recruitment, No pulmonary recruitment
- Medical subject headings
- Pneumoperitoneum, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary recruitmentProcedure or surgery
At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt
No pulmonary recruitmentProcedure or surgery
At the end of surgery no intervention was completed
| Study group | Role | What they receive |
|---|---|---|
| Low pressure pneumoperitoneum | Other | Surgery on low pressure pneumoperitoneum (8 - 10 mmHg). Receives: Procedure: No pulmonary recruitment |
| low pressure peritoneum and pulmonary recruitment | Active comparator | 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 Receives: Procedure: Pulmonary recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief during the first 24 hours
VAS (0-10)
Measured: 24hours
Secondary outcomes (3)
Total analgesic use during the first 24 hours
Measured: 24hours
Length of hospital stay
Measured: 2 days
Recovery after 48 hours
quality of recovery scale
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startMay 2015
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital Groeninge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casier Isabelle, General Hospital Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069586
- Sponsor's protocol ID
- AZGS2014160
- Status last verified
- Feb 2017
- First submitted
- 10 Feb 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Pressure Pneumoperitoneum and Pulmonary Recruitment Manoeuvre on Postoperative Pain After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03069586
- Acronym / sponsor ID
- AZGS2014160
- Conditions
- Pneumoperitoneum, Recruitment, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pressure pneumoperitoneum | Other | Procedure: No pulmonary recruitmentSurgery on low pressure pneumoperitoneum (8 - 10 mmHg). |
| low pressure peritoneum and pulmonary recruitment | Active comparator | Procedure: Pulmonary recruitmentSurgery 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I and II
Key exclusion criteria (5 listed)
- refusal to give consent
- cholecystitis
- BMI above 35
- intolerance to one of the pain medication
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary recruitmentAt the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt | Procedure or surgery | low pressure peritoneum and pulmonary recruitment |
| No pulmonary recruitmentAt the end of surgery no intervention was completed | Procedure or surgery | Low pressure pneumoperitoneum |
Primary outcome
pain relief during the first 24 hours
Time frame: 24hours
VAS (0-10)
3 secondary outcomes
Total analgesic use during the first 24 hours
Time frame: 24hours
Length of hospital stay
Time frame: 2 days
Recovery after 48 hours
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary recruitment and No pulmonary recruitment in people with Pneumoperitoneum and Recruitment, run by General Hospital Groeninge at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief during the first 24 hours (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.