Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03026543
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ebba Kihlstedt Pasquier, Region Östergötland

Brief 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Postoperative Nausea and Vomiting Procedure: Pulmonary Recruitment Maneuver Procedure: Laparoscopic cholecystectomy Device: Ventilator Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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: Pulmonary Recruitment Maneuver
Procedure: Laparoscopic cholecystectomy
Device: Ventilator
Active Comparator: Control group
Ordinary ventilation at the end of laparoscopic cholecystectomy.
Procedure: Laparoscopic cholecystectomy
Device: Ventilator



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026543


Contacts
Layout table for location contacts
Contact: Ebba Kihlstedt Pasquier, MD +46104100000 ebba.kihlstedt.pasquier@regionostergotland.se
Contact: Ellen Andersson, MD, PhD +46104100000 ellen.andersson@regionostergotland.se

Locations
Layout table for location information
Sweden
Vrinnevi Hospital Recruiting
Norrkoping, Östergötland, Sweden, 603 79
Contact: Ebba Kihlstedt Pasquier, MD    +46104100000    ebba.kihlstedt.pasquier@regionostergotland.se   
Contact: Ellen Andersson, MD, PhD    +46104100000    ellen.andersson@regionostergotland.se   
Sponsors and Collaborators
Region Östergötland
Investigators
Layout table for investigator information
Principal Investigator: Ebba Kihlstedt Pasquier, MD Vrinnevi Hospital, Norrköping, Sweden
Study Chair: Ellen Andersson, MD, PhD Vrinnevi Hospital, Norrköping, Sweden

Layout table for additonal information
Responsible Party: Ebba Kihlstedt Pasquier, Principal Investigator, Region Östergötland
ClinicalTrials.gov Identifier: NCT03026543     History of Changes
Other Study ID Numbers: Regionostergotland
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations