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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003682-19-BE

Enrollment

400

Registered

2020-12-04

Start date

2020-12-18

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To determine whether oxycodone gives better postoperative pain relief (using VAS scores) than IV piritramide in abdominal and gynecological surgery.

Interventions

Trade Name: Oxycodon - OxyNorm Product Name: Oxycodone Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: Oxycodone CAS Number: 124-90-3 Current Sponsor code: 52

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

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

Countries

Belgium

Contacts

Public ContactEvelien Vandeurzen

Department of Anesthesiology and perioperative medicine

evelien.vandeurzen@uzbrussel.be024749237

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026