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

Region Östergötland0 sites200 target enrollmentNovember 2014

ConditionsPain, Postoperative Postoperative Nausea and Vomiting

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pain, Postoperative
Sponsor: Region Östergötland
Enrollment: 200
Primary Endpoint: Postoperative Pain
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

May 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Region Östergötland

Responsible Party

Principal Investigator

Ebba Kihlstedt Pasquier

Principal Investigator

Region Östergötland

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

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: 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.