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NCT03026543 Clinical Trial

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

Pain, Postoperative Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03026543
Other study ID # Regionostergotland
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date December 31, 2018

Study information
Verified date May 2024
Source Region Östergötland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 260
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Pulmonary Recruitment Maneuver

• Laparoscopic cholecystectomy

Device:
• Ventilator

Locations
Country Name City State
Sweden Vrinnevi Hospital Norrkoping Östergötland

Sponsors (1)
Lead Sponsor Collaborator
Region Östergötland

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Kihlstedt Pasquier E, Andersson E. Pulmonary Recruitment Maneuver Reduces Shoulder Pain and Nausea After Laparoscopic Cholecystectomy: A Randomized Controlled Trial. World J Surg. 2021 Dec;45(12):3575-3583. doi: 10.1007/s00268-021-06262-6. Epub 2021 Sep 5 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 4, 12, 24, 36 and 48 hours after surgery
Secondary Change in postoperative nausea assessed with a Questionnaire A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. 4, 12, 24, 36 and 48 hours after surgery
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