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

Region Östergötland260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

260

Conditions

Pain, Postoperative Postoperative Nausea and Vomiting

Interventions

Pulmonary Recruitment ManeuverPROCEDURE

Laparoscopic cholecystectomyPROCEDURE

VentilatorDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vrinnevi Hospital

Norrköping, Östergötland County, Sweden

Outcomes

Primary Outcomes

Change in postoperative pain assessed with a numeric rating scale

A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.

Time frame: 4, 12, 24, 36 and 48 hours after surgery

Secondary Outcomes

Change in postoperative nausea assessed with a Questionnaire

A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.

Time frame: 4, 12, 24, 36 and 48 hours after surgery

Data from ClinicalTrials.gov

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