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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026530
• Other study ID #: Region Östergötland
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: December 2018
• Source: Region Östergötland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Procedure:
• Pulmonary recruitment maneuver
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.
• Laparoscopic bariatric surgery

Device:
• Ventilator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Östergötland

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4, 12, 24, 36 and 48 hours after surgery
Secondary	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.	4, 12, 24, 36 and 48 hours after surgery