Pain, PostoperativeNCT03026530

Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery

A study testing Pulmonary recruitment maneuver, Laparoscopic bariatric surgery and Ventilator in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Region Östergötland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this prospective, blinded, randomized clinical trial is to investigate whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall postoperative pain and nausea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative, Postoperative Nausea and Vomiting
What is being tested?: Pulmonary recruitment maneuver, Laparoscopic bariatric surgery and Ventilator
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: No sites listed yet
Study dates: Nov 2014to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

elective laparoscopic bariatric surgery (LBS)
American Society of Anaesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
written consent

Who cannot join

conversion to open surgery
complication, Clavien-Dindo grade ≥ II

About this study

Conditions: Pain, Postoperative, Postoperative Nausea and Vomiting
Being tested: Pulmonary recruitment maneuver, Laparoscopic bariatric surgery, Ventilator
Medical subject headings: Pain, Postoperative, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulmonary recruitment maneuverProcedure or surgery
The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgeryProcedure or surgery
VentilatorDevice

Study groups in NCT03026530
Study group	Role	What they receive
Pulmonary recruitment maneuver	Experimental	Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery. Receives: Procedure: Pulmonary recruitment maneuver; Procedure: Laparoscopic bariatric surgery; Device: Ventilator
Control group	Active comparator	Ordinary ventilation at the end of laparoscopic bariatric surgery. Receives: Procedure: Laparoscopic bariatric surgery; Device: Ventilator

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Pain
A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.
Measured: 4, 12, 24, 36 and 48 hours after surgery

Secondary outcomes (1)

Postoperative Nausea
A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea.
Measured: 4, 12, 24, 36 and 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014May 2016

First posted20 Jan 2017 (estimated)
Study startNov 2014
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03026530
Sponsor's protocol ID: Region Östergötland
Status last verified: Dec 2018
First submitted: 12 Jan 2017
Last updated: 5 Dec 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22.
PubMed 29290563

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
ClinicalTrials.gov ID: NCT03026530
Acronym / sponsor ID: Region Östergötland
Conditions: Pain, Postoperative, Postoperative Nausea and Vomiting
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Region ÖstergötlandUniversity, hospital or other
Study start: Nov 2014
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 20 Jan 2017 (estimated)
Results: Posted 5 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Pulmonary recruitment maneuver	Experimental	Procedure: Pulmonary recruitment maneuver, Procedure: Laparoscopic bariatric surgery, Device: VentilatorVentilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Control group	Active comparator	Procedure: Laparoscopic bariatric surgery, Device: VentilatorOrdinary ventilation at the end of laparoscopic bariatric surgery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

elective laparoscopic bariatric surgery (LBS)
American Society of Anaesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
written consent

Key exclusion criteria (2 listed)

conversion to open surgery
complication, Clavien-Dindo grade ≥ II

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 recruitment maneuverThe participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.	Procedure or surgery	Pulmonary recruitment maneuver
Laparoscopic bariatric surgery	Procedure or surgery	Control group, Pulmonary recruitment maneuver
Ventilator	Device	Control group, Pulmonary recruitment maneuver

Primary outcome

Postoperative Pain
Time frame: 4, 12, 24, 36 and 48 hours after surgery
A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.

1 secondary outcome

Postoperative Nausea
Time frame: 4, 12, 24, 36 and 48 hours after surgery

Results and safety

Results posted to the registry on 5 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pulmonary Recruitment Maneuver	100	79
Control Group	100	71

Primary outcome: Postoperative Pain

Time frame: 4, 12, 24, 36 and 48 hours after surgery. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Pulmonary Recruitment Maneuver n = 79	Control Group n = 71
4 hr	3 (1 to 3)	2 (1 to 4)
12 hr	2 (1 to 4)	3 (1 to 4)
24 hr	2 (1 to 3)	3 (2 to 5)
36 hr	2 (1 to 3)	2 (1 to 4)
48 hr	1 (0 to 2)	1 (0 to 2.75)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pulmonary Recruitment Maneuver	0 of 100 (0%)	0 of 100 (0%)	Not reported
Control Group	0 of 100 (0%)	0 of 100 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29290563Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22.

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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.

Ebba Kihlstedt Pasquier, MD principal investigator

Vrinnevi Hospital, Norrköping, Sweden

Ellen Andersson, MD, PhD study chair

Vrinnevi Hospital, Norrköping, Sweden

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary recruitment maneuver, Laparoscopic bariatric surgery and Ventilator in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Region Östergötland.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 5 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain (time frame: 4, 12, 24, 36 and 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03026530, which also lists 1 linked publication.

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 5 Dec 2018.