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

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting; Pain, Postoperative

• 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

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.