Skip to content

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510789-17-00
Acronym
OVIKA-trial S68618
Enrollment
108
Registered
2024-06-03
Start date
2024-09-03
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Postoperative pain relief after knee arthroscopy

Brief summary

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

Detailed description

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, NRS for pain 4h after discharge, NRS for pain 24h after discharge, Mean dose of opioid rescue medication (mean calculated per patient), Presence of Post-Operative Nausea and Vomiting (PONV) (at least once), Number of times emetics were used after discharge until 24 hours postop, Analgesic use during the first 24 hours, Economic evaluation, Quality of Recovery-40 questionnaire

Interventions

DRUGNatriumchlorid 0
DRUG9 % w/v Viaflo
DRUGPARACETAMOL
DRUGNaCl 0
DRUGsolution pour perfusion
DRUGIBUPROFEN
DRUGtablet

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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, NRS for pain 4h after discharge, NRS for pain 24h after discharge, Mean dose of opioid rescue medication (mean calculated per patient), Presence of Post-Operative Nausea and Vomiting (PONV) (at least once), Number of times emetics were used after discharge until 24 hours postop, Analgesic use during the first 24 hours, Economic evaluation, Quality of Recovery-40 questionnaire

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026