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

Phase 4

Recruiting

• Conditions: Postoperative pain relief after knee arthroscopy

• Registration Number: 2024-510789-17-00
• Lead Sponsor: UZ Leuven

Brief Summary

Evaluating the analgesic effect of oral versus intravenous analgesics postoperative

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• 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: Not specified
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium

UZ Leuven

🇧🇪Leuven, Belgium

An Teunkens

Site contact

+3216344270

an.teunkens@uzleuven.be