Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
108
Countries
1
Sites
1
Postoperative pain relief after knee arthroscopy
Evaluating the analgesic effect of oral versus intravenous analgesics postoperative
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 3 Sep 2024 → 15 Jan 2026
- Decision date (initial)
- 2024-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Laboratoria Wolfs Westpoort 50, 2070 Zwijndrecht - www.wolfs.eu
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy, Prophylaxis, Pharmacoeconomic
Evaluating the analgesic effect of oral versus intravenous analgesics postoperative
Secondary objectives 1
- Effect on PONV, discharge and economics
Conditions and MedDRA coding
Postoperative pain relief after knee arthroscopy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10036237 | Post operative analgesia | 10042613 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening During screening written informed consent will be obtained, inclusion & exclusion criteria will be checked, demographic data and vital signs will be recorded; Baseline pain score wil be assessed
|
Not Applicable | None | ||
| 2 | Randomisation Patient's eligibility criteria will be checked. Patient wil be randomised by an unblinded memeber of the study team not involved in patient care. Patients will be randomised in two groups.
|
Randomised Controlled | Double | [{"id":58633,"code":1,"name":"Subject"},{"id":58635,"code":2,"name":"Investigator"},{"id":58634,"code":5,"name":"Carer"}] | Intervention group: The intervention group will receive 30 minutes before general anaesthesia oral paracetamol 1000 mg and ibuprofen 600 mg and 30 minutes before the end of surgery two infusions containing 100ml of normal saline 0.9 Control group: The control group will receive 30 minutes before general anaesthesia, two placebo pills and 30 minutes before the end of surgery intravenous paracetamol 1000 mg and ibuprofen 600mg. |
| 3 | Surgery All patients will receive at induction of general anaesthesia: sufentanil 0.15 µg/kg, 0.5 mg/kg lidocaine, and propofol in a target-controlled infusion (TCI). Remifentanil 0.15µg/kg/min and propofol TCI are used to maintain anaesthesia. The airway will be secured with a laryngeal mask. Every patient will receive 10 mg dexamethasone and 4 mg ondansetron as prophylactic antiemetic medication0 min before the start of the surgery the blinded investigator will administer the oral trial medication to the subject.
30 min before the end of surgery the IV trial medication will be administerd to the patient
|
Randomised Controlled | Double | [{"id":58637,"code":1,"name":"Subject"},{"id":58639,"code":2,"name":"Investigator"},{"id":58638,"code":5,"name":"Carer"}] | |
| 4 | Follow- up At 2min, 15min, 30min and at dischargepostoperatively vital signs will be checked and pain scores will be recorded.
4h and 24h after discharge patient will be contacted by phone to evaluate pain scores and analgesic consumption
|
Not Applicable | Double | [{"id":58642,"code":1,"name":"Subject"},{"id":58643,"code":5,"name":"Carer"},{"id":58641,"code":2,"name":"Investigator"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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 7
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 10
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB08098MIG · Substance
- Active substance
- Ibuprofen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
SUB08098MIG · Substance
- Active substance
- Ibuprofen
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 3
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Natriumchlorid 0,9 % w/v Viaflo, Infusionslösung
PRD1606932 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 ml millilitre(s)
- Max total dose
- 200 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XX — OTHER I.V. SOLUTION ADDITIVES
- Marketing authorisation
- BE 253827
- MA holder
- BAXTER SA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
NaCl 0,9 % B. Braun, solution pour perfusion
PRD5372762 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- BE138476
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- department of Anesthesiology
Public contact point
- Organisation
- UZ Leuven
- Contact name
- department of Anesthesiology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 108 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-09-03 | 2026-01-15 | 2024-09-11 | 2026-01-14 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-12 | Belgium | Acceptable 2024-06-03
|
2024-06-03 |