Back to resultsEffect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
Primary Purpose
Pain, Postoperative, Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary recruitment maneuver
Laparoscopic bariatric surgery
Ventilator
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- conversion to open surgery
- complication, Clavien-Dindo grade ≥ II
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pulmonary recruitment maneuver
Control group
Arm Description
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Ordinary ventilation at the end of laparoscopic bariatric surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03026530
Brief Title
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
Official Title
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland
4. Oversight
5. Study Description
Brief 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.
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
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary recruitment maneuver
Arm Type
Experimental
Arm Description
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Ordinary ventilation at the end of laparoscopic bariatric surgery.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary recruitment maneuver
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic bariatric surgery
Intervention Type
Device
Intervention Name(s)
Ventilator
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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.
Time Frame
4, 12, 24, 36 and 48 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative Nausea
Description
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.
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 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
Exclusion Criteria:
conversion to open surgery
complication, 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
29290563
Citation
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.
Results Reference
result
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Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
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