Post-operative patient controlled intravenous oxyco-done vs patient controlled intrav nous piritramide. A randomized controlled trial.

Phase 1

• Conditions: To determine whether oxycodone gives better postoperative pain relief (using VAS scores) than IV piritramide in abdominal and gynecological surgery.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-003682-19-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-04
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

•= 18 years
•ASA class I, II or III
•Abdominal or gynecological surgery (both open as laparoscopic)

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 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Patient has shown an oversensitivity to oxycodone or piritramide
•Patients requiring urgent surgery (e.g. hemoperitoneum, bowel perforation, GI obstruction)
•Disorders that might have an effect on perception of pain (e.g. fibromyalgia, psychiatric dis-orders)
•Liver insufficiency
•Renal insufficiency witch clearance < 10ml/min
•Pregnancy / breast feeding
•Patients enrolled in another study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether oxycodone gives better postoperative pain relief (using VAS scores) than IV piritramide in abdominal and gynecological surgery.;Secondary Objective: To compare the adverse reactions, total amount of used medication and patient satisfaction between the oxycodone and piritramide group.;Primary end point(s): Sample sizes are calculated on 37 patients per group, so 74 in total. To account for possible drop-outs, we want to include 80 patients in this study, 40 in each study group. The study will be ended when we included 80 patients in total.;Timepoint(s) of evaluation of this end point: Sample sizes are calculated on 37 patients per group, so 74 in total. To account for possible drop-outs, we want to include 80 patients in this study, 40 in each study group. The study will be ended when we included 80 patients in total.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Adverse events:<br>a.Nausea<br>b.Sedation (Richmond agitation/sedation scale)<br>c.Urinary Retention<br>d.Constipation<br>e.Itching<br>2.Amount of medication used:<br>a.Time until first bolus<br>b.Total amount of boluses<br>3.Patient satisfaction<br>;Timepoint(s) of evaluation of this end point: The study will take approximately 4 days, not including the screening phase.