Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruiting
Participants planned
111
Countries
1
Sites
1
lumbar arthrodesis
Determine the reduction in morphine consumption in mg
Key facts
- Sponsor
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- 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], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 13 Nov 2025 → ongoing
- Decision date (initial)
- 2024-12-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- IRBLleida
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Determine the reduction in morphine consumption in mg
Secondary objectives 2
- To evaluate the efficacy of Ropivacaine in improving postoperative pain
- To characterize the safety and tolerability of Ropivacaine injection
Conditions and MedDRA coding
lumbar arthrodesis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | LLT | 10086110 | Spinal arthrodesis | 100000004848 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participant must be ≥18 years old at the time of signing the Informed Consent
- To have a lumbar arthrodesis programmed at the Hospital Universitari Arnau de Vilanova de Lleida
- ASA grade I-III
- Participant must be capable of giving Informed Consent
Exclusion criteria 11
- Specific contraindications for Ropivacaine treatment
- IMC >35
- Known medical history or evidence of severe liver disease and/or renal impairment (eGFR <30).
- Previous back surgery
- Evidence of immunological diseases
- Evidence of malignancy
- Systemic active infection that requires treatment
- Skin disease at the puncture site
- Active psychiatric disorder, including, but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention
- Other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
- Mujeres embarazadas o en periodo de lactancia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Morphine demand during the 48 hours after surgery
Secondary endpoints 5
- Changes in the VAS scale just after surgery, at 8, 16, 24 and 48 hours after surgery
- Changes in SFMPQ at 24 and 48 hours after surgery
- Changes in QoR-15 scales at 24 and 48 hours after surgery
- Duration of hospitalization after surgery
- Number of adverse effects associated with the drug within the first 48 hours after surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ropivacaine B. Braun 10 mg/ml injektionsvätska, lösning
PRD607845 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 42957
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Sponsor organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Address
- Avinguda De L'Alcalde Rovira Roure 80
- City
- Lleida
- Postcode
- 25196
- Country
- Spain
Scientific contact point
- Organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Contact name
- Diego Arango Del Corro
Public contact point
- Organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Contact name
- Diego Arango Del Corro
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 111 | 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 |
|---|---|---|---|---|---|
| Spain | 2025-11-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-511406-23-00_for publication | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_notpublic | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_public | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ropivacaina | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511406-23-00_ROPIDOL_en | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511406-23-00_ROPIDOL_summary_sp | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-16 | Spain | Acceptable 2024-12-10
|
2024-12-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-07 | Spain | Acceptable 2025-07-04
|
2025-07-04 |