Pain caused by bladder removal

Phase 1

• Conditions: Bladder cancer; MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-004581-18-DK
• Lead Sponsor: one Nikolajsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-24
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• All patients
• = 18 years
• Planned for bladder removal

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

•American Society of Anesthesiologists (ASA) physical status IV or V (21)
•Prolonged QTc-interval assessed by electrocardiogram (> 440 milliseconds)
•Existing treatment with a high risk of QTc-interval prolongation
•Allergy to study drugs
•Preoperative daily use of opioids
•Inability to provide informed consent
•Severe respiratory insufficiency (oxygen treatment at home)
•Heart failure (ejection fraction < 30%)
•Acute abdominal pain
•Signs of severe liver dysfunction (cirrhosis, inflammation/hepatitis or liver malignancy)
•Severe kidney insufficiency (estimated Glomerular Filtration Rate < 30 ml/min)
•Treatment with rifampicin
• Treatment with MAO-inhibitor during the last 14 days
• Pregnancy
• Nursing mothers
• Phaeochromocytoma
•Intraoperative conversion to open surgery (secondary inclusion criterion)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •Opioid consumption within the first 3/24 hours ;Secondary Objective: •Postoperative pain intensity within the first 24 hours (at 1, 3, 6, 18, 24 hrs) <br>•Nausea and/or vomiting at 3 and 24 hours; sedation at 3 hours.<br>•Hypoventilation/hypoxemia in the PACU<br>•Patient satisfaction with pain management at 24 hours after extubation<br>•Time from arrival to readiness for discharge from PACU and hospital (hours and minutes) <br>;Primary end point(s): •Opioid consumption ;Timepoint(s) of evaluation of this end point: 3/24 hours after extubation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Pain intensity (NRS, 0-10) at rest and coughing <br>•Nausea and/or vomiting (PONV) on a 4-point Likert scale (none/mild/moderate/severe) <br>•Level of sedation in the PACU (Ramsey sedation score)<br>•Any adverse events during observation at the PACU:<br> - Hypoventilation<br> - Hypoxemia<br>•Patient satisfaction (NRS, 0-10) with pain management <br>•Time from arrival to readiness for discharge from PACU and hospital (hours and minutes);Timepoint(s) of evaluation of this end point: Pain - 1, 3, 6, 18 and 24 hours after extubation <br>Nausea and/or vomiting - 3 and 24 hours <br>Sedation - 3 hours <br>Adverse events <br>- hypoventilation (respiratory rate <10/minutes)<br>- hypoxemia (peripheral oxygen saturation <94%)<br>Patient satisfaction - 24 hours <br>