To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
517
Teaching Hospital Bulovka, Department of Urology
Prague, Czechia
Anaesthetisia - Resuscitation Department, Tenon Hospital
Paris, Cedex 20, France
Universitätsklinikum Bonn, Klinik und Poliklinik f. Anaesthesiologie
Bonn, Germany
Department of Anaesthesiology, Leiden University Medical Centre
Leiden, Netherlands
Incidence and severity of nausea
To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24-hour post-operative period. Pain relief and nausea were determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.
Time frame: The 6-18 hour period after titration to pain relief
Analgesic effect
To compare the analgesic effect of the study treatments using an Investigator- and patient-administered VRS-11 scale of pain intensity over the following time periods following achievement of baseline pain relief. 1. 0-12 hours (AUCbaseline-12) 2. 0-48 hours (AUCbaseline - 48) 3. 12-24 hours (AUC12 - 24) 4. 24-48 hours (AUC24 - 48) Pain levels will be compared using the AUC from baseline.
Time frame: 0-48 hours after titration to pain relief
The incidence and severity of nausea
To compare the incidence and severity of nausea in the study treatment groups over the following time periods following achievement of baseline pain relief: 0-12 hours, 0-24 hours, 0-48 hours, 12-24 hours, 24-48 hours.
Time frame: 0-48 hours
The incidence and severity of vomiting
To compare the incidence and severity of vomiting in the study treatment groups over the following time periods following achievement of baseline pain relief: 0-12 hours, 0-24 hours, 0-48 hours, 12-24 hours, 24-48 hours
Time frame: 0-48 hours
The amounts of study drug required to achieve a baseline pain severity score of ≤ 3
To compare the amounts of study drug required to achieve a baseline pain severity score of ≤ 3
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Ii Klinika Anestezjologii i It
Lublin, Poland
Intensive Care Unit, Level 5, Western Infirmary,
Glasgow, Renfrewshire, United Kingdom
St John's Hospital
Livingston, West Lothian, United Kingdom
Time frame: 60-30mins before close of surgery to time 0.