Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
114
Countries
1
Sites
1
Total hip arthroplasty under spinal anesthesia
The primary objective is to demonstrate the usefulness of intrathecal administration of morphine (ITM) with or without ropivacaine in supra-inguinal fascia iliaca compartment block (SFIB) in total hip arthrpplasty (THA) to improve analgesia and reduce pain at mobilization (numeric rating scale, NRS 0 to 10) 8 hours aft…
Key facts
- Sponsor
- Centre hospitalier universitaire de Liege
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 12 Jun 2024 → 6 Nov 2025
- Decision date (initial)
- 2024-05-08
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The primary objective is to demonstrate the usefulness of intrathecal administration of morphine (ITM) with or without ropivacaine in supra-inguinal fascia iliaca compartment block (SFIB) in total hip arthrpplasty (THA) to improve analgesia and reduce pain at mobilization (numeric rating scale, NRS 0 to 10) 8 hours after surgery.
Conditions and MedDRA coding
Total hip arthroplasty under spinal anesthesia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult man/women over 18 and less 85 years old
- American Society of Anesthesiologists (ASA) Physical Status 1 or 2 or 3
- Able to speak, read and understand French
- Admitted for scheduled elective total hip replacement surgery with spinal anesthesia
Exclusion criteria 14
- Pregnant women (or woman of childbearing potential who are breastfeeding or not taking an effective contraception, defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly, cfr. CTFG Guidelines “Recommendations related to contraception and pregnancy testing in clinical trials”)
- Patients with peripheral neuropathy or other severe neurological pathology
- Patients unable to give consent
- Patients with chronic pain syndromes or chronic opioid addiction (more than 20 mg per day of equivalents oral morphine)
- Chronic renal failure (glomerular filtration rate < 45 mL/min/1.73 m2)
- Severe liver failure
- Recent (<12 months) thrombo-embolic events
- Suspected or confirmed allergy to local anesthetics or morphine
- Allergy or hypersensitivity to the active ingredient or to any of the excipients of MORPHINE HCl STEROP, MINI-PLASCO NaCl BBRAUN 0,9% or Naropin 0.75%
- Any patients where intrathecal morphine low dose (100 mcg) is contraindicated
- Patients over 85 years old
- Acute respiratory failure
- Patients with acute abdominal syndrome, spasm of the sphincter of Oddi, bile duct contraction, pyloric spasm, intracranial hypertension, convulsive states, coma.
- Patients with alcohol intoxication, barbiturate intoxication or acute porphyria.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoints will be dynamic NRS pain (NRS 0 to 10) at passive 90- degree flexion of the lower limb on the trunk in the supine position at 8 hours after surgery.
Secondary endpoints 6
- Total consumption of morphine equivalents during the first 48 hours post- operatively, through IV administration of morphine on a Patient Controlled Intravenous Analgesia (PCIA) device.
- NRS pain scores at rest and mobilization at fixed times: 8 hours after surgery, at 8:00 am, 1:00 pm and 6:00 pm on the first (D1) and second (D2) day after surgery (pain trajectory)
- Postoperative complications such as: orthostatic intolerance, falls and postoperative nausea and vomiting
- Morphine-related side effects: bladder globe, constipation, dizziness and drowsiness
- Patient's pain related experience assessed by the International Pain Outcome (IPO) questionnaire at D2
- Quality-of-Recovery 15-items (QoR-15) score for assessment of functional recovery on D1, D2, day-7 (D7) and day-30 (D30)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
MORPHINE HCl STEROP 10mg/1ml Solution injectable
PRD7571642 · Product
- Active substance
- Morphine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Max daily dose
- 100 µg microgram(s)
- Max total dose
- 100 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- BE414346
- MA holder
- LABORATOIRES STEROP
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
NAROPIN 7,5 mg/ml, solution injectable
PRD4858919 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- BE177344
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
MINI-PLASCO NACL B. BRAUN 0,9 %, oplossing voor injectie
PRD5424751 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 40 ml millilitre(s)
- Max total dose
- 40 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- BE119016
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MINI-PLASCO NACL B. BRAUN 0,9 %, solution injectable
PRD5414432 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- BE119016
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 5
Etoricoxib AB 60 mg comprimés pelliculés
PRD5266476 · Product
- Active substance
- Etoricoxib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 180 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AH05 — -
- Marketing authorisation
- BE506782
- MA holder
- AUROBINDO N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dafalgan Caps Forte 1 g harde capsules
PRD11090317 · Product
- Active substance
- Paracetamol
- Substance synonyms
- ACETAMINOPHEN
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 20 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- BE662104
- MA holder
- UPSA SAS
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Linisol 1 %, solution injectable
PRD5359608 · Product
- Active substance
- Lidocaine Hydrochloride Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- BE166695
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MARCAINE 0,5 %, solution injectable
PRD4877143 · Product
- Active substance
- Bupivacaine Hydrochloride, Anhydrous
- Substance synonyms
- ANHYDROUS BUPIVACAINE HYDROCHLORIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- BE078251
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Aacidexam 5 mg/ml solution injectable
PRD4933050 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- BE080026
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre hospitalier universitaire de Liege
- Sponsor organisation
- Centre hospitalier universitaire de Liege
- Address
- Avenue De L'hopital 1
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- Centre hospitalier universitaire de Liege
- Contact name
- Michele Carella
Public contact point
- Organisation
- Centre hospitalier universitaire de Liege
- Contact name
- Michele Carella
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 114 | 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 | 2024-06-12 | 2025-11-06 | 2024-06-12 | 2025-10-06 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-23 | Belgium | Acceptable 2024-05-06
|
2024-05-08 |