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

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting; Pain, Postoperative
• Interventions: Procedure: Pulmonary recruitment maneuver; Procedure: Laparoscopic bariatric surgery; Device: Ventilator

• Registration Number: NCT03026530
• Lead Sponsor: Region Östergötland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-20
• Results First Submitted: 2018-09-03
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Results First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary recruitment maneuver	Laparoscopic bariatric surgery	Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Control group	Ventilator	Ordinary ventilation at the end of laparoscopic bariatric surgery.
Pulmonary recruitment maneuver	Pulmonary recruitment maneuver	Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Pulmonary recruitment maneuver	Ventilator	Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Control group	Laparoscopic bariatric surgery	Ordinary ventilation at the end of laparoscopic bariatric surgery.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	4, 12, 24, 36 and 48 hours after surgery	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

Name	Time	Method
Postoperative Nausea	4, 12, 24, 36 and 48 hours after surgery	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.