Perioperative oral analgesia versus intravenous analgesia for knee arthroscopy, a randomized, double-blinded, non-inferiority trial. OVIKA-trial - S68618

Phase 1

Conditions: Postoperative pain relief after knee arthroscopy
MedDRA version: 20.0Level: LLTClassification code: 10036237Term: Post operative analgesia Class: 10042613
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: CTIS2024-510789-17-00

Lead Sponsor: Z Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 108

Inclusion Criteria

Minor knee surgery under general anaesthesia, including arthroscopic meniscectomy and synovectomy, diagnostic arthroscopy, meniscus repair and arthroscopic lavage., >=18 years of age, ASA 1-3 suitable for ambulatory surgery, >= 50 kg, Voluntary written informed consent of the participant, Dutch speaking

Exclusion Criteria

History of liver diseases, renal insufficiency, epilepsy, allergy to paracetamol or ibuprofen, Any disorder which, in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial., Participation in an interventional Trial with an investigational medicinal product (IMP) or device., A contraindication for the use of paracetamol or ibuprofen, Non-compliance of the patient, postive urine pregnancy test in women of childbearing potential

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluating the analgesic effect of oral versus intravenous analgesics postoperative;Secondary Objective: Effect on PONV, discharge and economics;Primary end point(s): The primary endpoint will be the mean postoperative pain scores measured with the Numeric Rating Scale (NRS) during for minor knee arthroscopy, measured once preoperatively and at different time points postoperatively up to discharge

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Key-secondary: - The need (number of patients) for postoperative rescue medication (morphine or clonidine) and time to readiness for discharge;Secondary end point(s):Timepoint-specific NRS for pain during the hospital stay;Secondary end point(s):NRS for pain 4h after discharge;Secondary end point(s):NRS for pain 24h after discharge;Secondary end point(s):Mean dose of opioid rescue medication (mean calculated per patient);Secondary end point(s):Presence of Post-Operative Nausea and Vomiting (PONV) (at least once);Secondary end point(s):Number of times emetics were used after discharge until 24 hours postop;Secondary end point(s):Analgesic use during the first 24 hours;Secondary end point(s):Economic evaluation;Secondary end point(s):Quality of Recovery-40 questionnaire