Overview
Sponsor-declared trial summary
proximal femur fracture
To verify that intrathecal administration of morphine results in better patient analgesia than administration of opioids by other routes.
Key facts
- Sponsor
- Fakultni Nemocnice Ostrava
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- completed 30 Sep 2025
- Decision date (initial)
- 2024-10-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University Hospital Ostrava
External identifiers
- EU CT number
- 2024-513996-42-00
- EudraCT number
- 2021-002765-17
- ClinicalTrials.gov
- NCT05920642
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To verify that intrathecal administration of morphine results in better patient analgesia than administration of opioids by other routes.
Secondary objectives 1
- To determine whether intrathecal administration of morphine is comparably safe to opioids submitted by another route.
Conditions and MedDRA coding
proximal femur fracture
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10016450 | Femoral neck fracture | 100000004863 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- ASA classification I - III
- patient indicated for procedure in subarachnoid block
- signed informed consent form
Exclusion criteria 3
- patient allergic to opioid analgesics
- the assumption of a high risk of postoperative respiratory depression
- procedure under general anaesthesia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- pain assessment using VAS10 at rest (value 0-10 according to pain intensity, measured every 2 h for 24 h)
- pain assessment using VAS10 while positioning the patient
- time until the first administration of rescue medication – analgesics
- total consumption of opioids in the ICU per 24 h
- the dose of administered non-opioid analgesics
Secondary endpoints 7
- monitoring of hypoventilation
- monitoring of hypotension
- monitoring of bradycardia
- postoperative nausea and vomiting
- effect of antiemetic mediation
- monitoring of pruritus
- the effectiveness of the treatment of pruritus
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP1000773 · ATC
- Route of administration
- INTRATHECAL USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fakultni Nemocnice Ostrava
- Sponsor organisation
- Fakultni Nemocnice Ostrava
- Address
- 17. Listopadu 1790/5, Poruba Poruba
- City
- Ostrava
- Postcode
- 708 00
- Country
- Czechia
Scientific contact point
- Organisation
- Fakultni Nemocnice Ostrava
- Contact name
- Denis Buršík
Public contact point
- Organisation
- Fakultni Nemocnice Ostrava
- Contact name
- Denis Buršík
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | FNO-KARIM2021_TT_Case report form - verze 5 | 5 |
| Protocol (for publication) | FNO-KARIM2021_TT_Protokol-verze_8 | 8 |
| Recruitment arrangements (for publication) | FNO-KARIM2021_TT_Popis zpusobu naboru subjektu hodnoceni_v2 | 2 |
| Subject information and informed consent form (for publication) | FNO-KARIM2021_TT_ICF_Main_morfin_v6 | 6 |
| Synopsis of the protocol (for publication) | FNO-KARIM2021_TT_Souhrn_protokolu_verze 2 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Czechia | Acceptable with conditions 2024-09-16
|
2024-10-31 |