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Clinical Trials/NCT03026543
NCT03026543
Completed
N/A

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

Region Östergötland1 site in 1 country260 target enrollmentOctober 2014
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ConditionsPain, PostoperativePostoperative Nausea and Vomiting

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Region Östergötland
Enrollment
260
Locations
1
Primary Endpoint
Change in postoperative pain assessed with a numeric rating scale
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 31, 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ebba Kihlstedt Pasquier

Principal Investigator

Region Östergötland

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Change in postoperative nausea assessed with a Questionnaire(4, 12, 24, 36 and 48 hours after surgery)

Study Sites (1)

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