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

A Prospective, Blinded, Randomized Clinical Trial Investigating the Effect on Postoperative Pain and Nausea, When Performing a Ventilator-piloted PRM at the End of Laparoscopic Cholecystectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03026543
Enrollment
260
Registered
2017-01-20
Start date
2014-10-31
Completion date
2018-12-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Postoperative Nausea and Vomiting

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.

Interventions

PROCEDURELaparoscopic cholecystectomy

Sponsors

Region Östergötland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in postoperative pain assessed with a numeric rating scale4, 12, 24, 36 and 48 hours after surgeryA questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.

Secondary

MeasureTime frameDescription
Change in postoperative nausea assessed with a Questionnaire4, 12, 24, 36 and 48 hours after surgeryA questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026