Back to resultsEffect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Cholecystectomy
Primary Purpose
Pain, Postoperative, Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Pulmonary Recruitment Maneuver
Laparoscopic cholecystectomy
Ventilator
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- Vrinnevi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pulmonary recruitment maneuver
Control group
Arm Description
One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
Ordinary ventilation at the end of laparoscopic cholecystectomy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in postoperative nausea assessed with a Questionnaire
A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03026543
Brief Title
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Cholecystectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary recruitment maneuver
Arm Type
Experimental
Arm Description
One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Ordinary ventilation at the end of laparoscopic cholecystectomy.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Recruitment Maneuver
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Type
Device
Intervention Name(s)
Ventilator
Primary Outcome Measure Information:
Title
Change in postoperative pain assessed with a numeric rating scale
Description
A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.
Time Frame
4, 12, 24, 36 and 48 hours after surgery
Secondary Outcome Measure Information:
Title
Change in postoperative nausea assessed with a Questionnaire
Description
A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.
Time Frame
4, 12, 24, 36 and 48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebba Kihlstedt Pasquier, MD
Organizational Affiliation
Vrinnevi Hospital, Norrköping, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Andersson, MD, PhD
Organizational Affiliation
Vrinnevi Hospital, Norrköping, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Vrinnevi Hospital
City
Norrkoping
State/Province
Östergötland
ZIP/Postal Code
603 79
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
34482412
Citation
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.
Results Reference
derived
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Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Cholecystectomy
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