Overview
Sponsor-declared trial summary
Total Hip Arthroplasty
To compare two regional anaesthesia techniques for primary hip replacement in terms of pain relief and muscular strength of the quadriceps
Key facts
- Sponsor
- Hospital Del Mar
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 8 May 2024 → ongoing
- Decision date (initial)
- 2024-03-15
- 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: Therapy
To compare two regional anaesthesia techniques for primary hip
replacement in terms of pain relief and muscular strength of the
quadriceps
Secondary objectives 4
- To compare lenght of hospital stay
- To compare patient mobilization
- To compare pain experience
- To compare incidence of adverse effects
Conditions and MedDRA coding
Total Hip Arthroplasty
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-507506-14-00 | Comparison of PENG block and lumbar plexus block in terms of postoperative analgesia and mobilization for fast track primary hip arthroplasty | Hospital Del Mar |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients scheduled for primary hip replacement who agree to participate in the study and sign the informed consent
Exclusion criteria 6
- Refusal to participate in the study
- blood coagulation dysfunction
- Neuropathies
- Punction site or systemic infections
- Local anesthestic alergies
- Women of reproductive age without contraceptive control, maternity or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Pain
- Quadriceps muscular strength
Secondary endpoints 5
- Adverse effects: Nausea, vomiting, sedation, toxicity, others
- Opioid consumption
- Need for additional analgesia
- Length of hospital stay
- Pain experience
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Levobupivacaína Altan 2,5 mg/ml solución inyectable y para perfusión EFG
PRD990726 · Product
- Active substance
- Levobupivacaine
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 62.5 mg milligram(s)
- Max total dose
- 62.5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB10 — LEVOBUPIVACAINE
- Marketing authorisation
- 78240
- MA holder
- ALTAN PHARMACEUTICALS S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio
PRD567870 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 25 ml millilitre(s)
- Max total dose
- 25 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 58449
- MA holder
- B.BRAUN MEDICAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Del Mar
- Sponsor organisation
- Hospital Del Mar
- Address
- Passeig Maritim De La Barceloneta 25-29
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Del Mar
- Contact name
- Xavier Santiveri
Public contact point
- Organisation
- Hospital Del Mar
- Contact name
- parc de salut mar
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 64 | 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 | 2024-05-08 | 2024-05-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-21 | Spain | Acceptable with conditions 2024-03-15
|
2024-03-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-08 | Spain | Acceptable 2024-07-04
|
2024-07-04 |