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

May 3, 2024 updated by: Ebba Kihlstedt Pasquier, Region Östergötland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

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

  • Sweden
    • Östergötland
      • Norrkoping, Östergötland, Sweden, 603 79
        • Vrinnevi Hospital

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • conversion to open surgery
  • Clavien-Dindo grade ≥ II

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary recruitment maneuver
One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
Procedure: Laparoscopic cholecystectomy
Device: Ventilator
Procedure: Pulmonary Recruitment Maneuver
Active Comparator: Control group
Ordinary ventilation at the end of laparoscopic cholecystectomy.
Procedure: Laparoscopic cholecystectomy
Device: Ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4, 12, 24, 36 and 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postoperative nausea assessed with a Questionnaire
Time Frame: 4, 12, 24, 36 and 48 hours after surgery
A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.
4, 12, 24, 36 and 48 hours after surgery

Collaborators and Investigators

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

Sponsor

Region Östergötland

Investigators

  • Principal Investigator: Ebba Kihlstedt Pasquier, MD, Vrinnevi Hospital, Norrköping, Sweden
  • Study Chair: Ellen Andersson, MD, PhD, Vrinnevi Hospital, Norrköping, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 1, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimated)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RegionOstergotland

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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