Pain, PostoperativeNCT03026543

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

A study testing Pulmonary Recruitment Maneuver, Laparoscopic cholecystectomy and Ventilator in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Region Östergötland at 1 site in Sweden.

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

This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy. 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 cholecystectomy and Ventilator
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 260 participants
Where: 1 siteSweden
Study dates: Oct 2014to 31 Dec 2018
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

elective laparoscopic cholecystectomy
American Society of Anesthesiologists (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
Clavien-Dindo grade ≥ II

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Vrinnevi Hospital
Norrköping, Östergötland County, 603 79

Other trials in Sweden

About this study

Official title: A Prospective, Blinded, Randomized Clinical Trial Investigating the Effect on Postoperative Pain and Nausea, When Performing a Ventilator-piloted PRM at the End of Laparoscopic Cholecystectomy

This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.

Conditions: Pain, Postoperative, Postoperative Nausea and Vomiting
Being tested: Pulmonary Recruitment Maneuver, Laparoscopic cholecystectomy, 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
Laparoscopic cholecystectomyProcedure or surgery
VentilatorDevice

Study groups in NCT03026543
Study group	Role	What they receive
Pulmonary recruitment maneuver	Experimental	One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen. Receives: Procedure: Pulmonary Recruitment Maneuver; Procedure: Laparoscopic cholecystectomy; Device: Ventilator
Control group	Active comparator	Ordinary ventilation at the end of laparoscopic cholecystectomy. Receives: Procedure: Laparoscopic cholecystectomy; Device: Ventilator

What is being measured

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

Change in postoperative pain assessed with a numeric rating scale
A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.
Measured: 4, 12, 24, 36 and 48 hours after surgery

Secondary outcomes (1)

Change in postoperative nausea assessed with a Questionnaire
A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.
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.

Oct 201431 Dec 2018

First posted20 Jan 2017 (estimated)
Study startOct 2014
Primary completion31 Dec 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03026543
Sponsor's protocol ID: Regionostergotland
Status last verified: May 2024
First submitted: 12 Jan 2017
Last updated: 6 May 2024
Results posted: No

Publications

Kihlstedt Pasquier E, Andersson E. Pulmonary Recruitment Maneuver Reduces Shoulder Pain and Nausea After Laparoscopic Cholecystectomy: A Randomized Controlled Trial. World J Surg. 2021 Dec;45(12):3575-3583. doi: 10.1007/s00268-021-06262-6. Epub 2021 Sep 5.
PubMed 34482412

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Blinded, Randomized Clinical Trial Investigating the Effect on Postoperative Pain and Nausea, When Performing a Ventilator-piloted PRM at the End of Laparoscopic Cholecystectomy
ClinicalTrials.gov ID: NCT03026543
Acronym / sponsor ID: Regionostergotland
Conditions: Pain, Postoperative, Postoperative Nausea and Vomiting
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Region ÖstergötlandUniversity, hospital or other
Study start: Oct 2014 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 20 Jan 2017 (estimated)
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.

This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.

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 cholecystectomy, Device: VentilatorOne minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
Control group	Active comparator	Procedure: Laparoscopic cholecystectomy, Device: VentilatorOrdinary ventilation at the end of laparoscopic cholecystectomy.

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 cholecystectomy
American Society of Anesthesiologists (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
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 Maneuver	Procedure or surgery	Pulmonary recruitment maneuver
Laparoscopic cholecystectomy	Procedure or surgery	Control group, Pulmonary recruitment maneuver
Ventilator	Device	Control group, Pulmonary recruitment maneuver

Primary outcome

Change in postoperative pain assessed with a numeric rating scale
Time frame: 4, 12, 24, 36 and 48 hours after surgery
A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.

1 secondary outcome

Change in postoperative nausea assessed with a Questionnaire
Time frame: 4, 12, 24, 36 and 48 hours after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
Results publication: PubMed 34482412Kihlstedt Pasquier E, Andersson E. Pulmonary Recruitment Maneuver Reduces Shoulder Pain and Nausea After Laparoscopic Cholecystectomy: A Randomized Controlled Trial. World J Surg. 2021 Dec;45(12):3575-3583. doi: 10.1007/s00268-021-06262-6. Epub 2021 Sep 5.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 May 2024. 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 Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in postoperative pain assessed with a numeric rating scale (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 NCT03026543, 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 6 May 2024.