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OpenTrials
Completed

NCT Number: NCT03026543

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

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.

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Key information

Conditions

Pain, Postoperative Nausea Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrinnevi Hospital

Norrköping, Östergötland County, 603 79, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary recruitment maneuver

Procedure

Laparoscopic cholecystectomy

Procedure

Ventilator

Device

Primary outcomes

  1. Change in postoperative pain assessed with a numeric rating scale

    Time frame: 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 outcomes

  1. Change in postoperative nausea assessed with a Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Östergötland

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2017
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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