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

Not Applicable

Completed

• Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting
• Interventions: Procedure: Laparoscopic cholecystectomy; Procedure: Pulmonary Recruitment Maneuver; Device: Ventilator

• Registration Number: NCT03026543
• Lead Sponsor: Region Östergötland

Brief Summary

This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-20
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• elective laparoscopic cholecystectomy
• American Society of Anesthesiologists (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
• Clavien-Dindo grade ≥ II

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary recruitment maneuver	Ventilator	One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
Control group	Laparoscopic cholecystectomy	Ordinary ventilation at the end of laparoscopic cholecystectomy.
Control group	Ventilator	Ordinary ventilation at the end of laparoscopic cholecystectomy.
Pulmonary recruitment maneuver	Pulmonary Recruitment Maneuver	One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
Pulmonary recruitment maneuver	Laparoscopic cholecystectomy	One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.

Primary Outcome Measures

Name	Time	Method
Change in postoperative pain assessed with a numeric rating scale	4, 12, 24, 36 and 48 hours after surgery	A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Change in postoperative nausea assessed with a Questionnaire	4, 12, 24, 36 and 48 hours after surgery	A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.

Trial Locations

Locations (1)

Vrinnevi Hospital; 🇸🇪 Norrkoping, Östergötland, Sweden