Overview
Sponsor-declared trial summary
Total knee arthroplasty
Evaluate the efficacy of perineural magnesium sulfate in prolonging analgesia when administered as an adjuvant to the local anesthetic ropivacaine in total knee arthroplasty.
Key facts
- Sponsor
- Fundacion Progreso Y Salud
- 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]
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518601-17-00
- EudraCT number
- 2021-002712-30
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Evaluate the efficacy of perineural magnesium sulfate in prolonging analgesia when administered as an adjuvant to the local anesthetic ropivacaine in total knee arthroplasty.
Conditions and MedDRA coding
Total knee arthroplasty
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients scheduled for total knee arthroplasty due to gonarthrosis
- ASA I, II, and III patients of both sexes.
- Age between 18 and 80 years.
- Informed consent signed, accepting participation in the study.
Exclusion criteria 14
- Allergy or intolerance to local anesthetics, morphine or its derivatives, magnesium sulfate.
- Diabetes mellitus with the last glycated hemoglobin control greater than 7%.
- Patients with neuromuscular diseases.
- Morbid obesity.
- Fibromyalgia
- Myofascial pain syndrome.
- Patients with prior treatment with corticosteroids or calcium antagonists in the last three months.
- Patients with cardiovascular disease (congestive heart failure, severe valvular disease, symptomatic coronary artery disease, and/or congenital/anatomical heart abnormalities).
- Patients with severe renal, hepatic, or respiratory disease.
- Patients with any condition that prevents the use of regional analgesia: anticoagulated, antiplatelet therapy, local or systemic infection.
- Patients with difficulty understanding study-related information and collaborating in pain assessment.
- Patients with major psychiatric pathology as per DSM-V.
- Pregnancy and/or breastfeeding.
- ASA IV Patients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time in minutes elapsed from when the patient receives the adductor canal block until the first request for rescue analgesia.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB14448MIG · Substance
- Active substance
- Magnesium Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 6
- Max total dose
- 6 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 100 g gram(s)
- Max total dose
- 1000 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
SUB04264MIG · Substance
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Progreso Y Salud
- Sponsor organisation
- Fundacion Progreso Y Salud
- Address
- Bloque 2, Calle Americo Vespucio 5, Parque Cientifico Y Tecnologico Cartuja 93 Calle Americo Vespucio 5 Parque Cientifico Y Tecnologico Cartuja 93
- City
- Sevilla
- Postcode
- 41092
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Progreso Y Salud
- Contact name
- David Lineros Orozco
Public contact point
- Organisation
- Fundacion Progreso Y Salud
- Contact name
- David Lineros Orozco
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 131 | 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 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PROTOCOL 2024_518601_17_00 | 3.0 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | ICF | 3.0 |
| Synopsis of the protocol (for publication) | PROTOCOL SYNOPSIS 2024_518601_17_00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-02 | Spain | Acceptable 2024-10-14
|
2024-10-14 |