Overview
Sponsor-declared trial summary
Knee Osteoarthritis
Compare the analgesic efficacy between Geniculate Nerve Blocks versus the combination of IPACK (infiltration between the popliteal artery and the capsule of the knee) and Adductor Canal Blocks in patients undergoing primary total knee replacement (TKR). This will be evaluated during the first physiotherapy session at 2…
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2026-02-06
- 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, Efficacy
Compare the analgesic efficacy between Geniculate Nerve Blocks versus the combination of IPACK (infiltration between the popliteal artery and the capsule of the knee) and Adductor Canal Blocks in patients undergoing primary total knee replacement (TKR). This will be evaluated during the first physiotherapy session at 24 hours postoperatively, using the Numerical Rating Scale (NRS) for pain assessment.
Secondary objectives 4
- Compare the cumulative consumption of rescue opioids at 24 and 48 hours between the aforementioned interventions.
- Assess and compare the analgesic efficacy between the aforementioned blocks in the postoperative period. This includes at the moment of spinal block reversal, and at 0, 12, and 48 hours using the NRS at rest.
- Evaluate the range of joint mobility during the initial assessment by physiotherapy.
- Measure the quality of recovery after surgery.
Conditions and MedDRA coding
Knee Osteoarthritis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- All patients undergoing primary total knee arthroplasty who provide consent to participate in the study and whose attending surgeon also agrees to the study.
- ASA physical status classification I-III.
- BMI 18-40 kg/m2.
Exclusion criteria 10
- Patients who refuse to undergo the block procedure, who refuse to give their consent, or who are unable to cooperate with protocol compliance.
- Patients requiring general anesthesia.
- Age younger than 18 years or older than 90 years.
- Patients undergoing bilateral arthroplasty, revision arthroplasties, or prosthetic replacements.
- Contraindication for peripheral nerve block (local infection, neurological deficit, complex regional pain syndrome, previous trauma, or surgery on the ipsilateral knee).
- Systemic infection.
- Consumption of opioids during the last 4 weeks at doses greater than 30 mg of oral morphine or equivalent.
- Patients with a hemorrhagic diathesis or coagulopathy (diagnosed by medical history or laboratory tests).
- Patients with allergies to any medication that is part of the protocol (e.g., allergy to local anesthetics).
- Patients in whom the total dose of local anesthetic exceeds the calculated toxic dose based on their ideal body weight.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The Numerical Rating Scale (NRS) for pain.
Secondary endpoints 4
- Opioid consumption measured in morphine equivalents in milligrams.
- Range mobility measured by active and passive Range of Motion (ROM) Assessment.
- Quality of recovery 15 (QoR 15 questionnare).
- Evaluate NRS at 0, 12 and 48h postoperatively.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Ropivacaína B. Braun 2 mg/ml solución inyectable y para perfusión EFG
PRD2147352 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 70 mg milligram(s)
- Max total dose
- 70 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 76678
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Adrenalina B. Braun 1 mg/ml Solución Inyectable
PRD11876805 · Product
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 350 µg microgram(s)
- Max total dose
- 350 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA — ADRENERGIC AND DOPAMINERGIC AGENTS
- Marketing authorisation
- 68552
- 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
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Clinical Trials Unit
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Clinical Trials Unit
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 64 | 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 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol ADIPGEN EN | 2.0 |
| Protocol (for publication) | Protocol ADIPGEN v2 1 EN | 2.1 |
| Protocol (for publication) | Protocol ADIPGEN v2 1 EN control de cambios | 2.1 |
| Recruitment arrangements (for publication) | Recruitment arrengements | 1 |
| Subject information and informed consent form (for publication) | Apendice 1 Informacion esencial para el paciente. | 1 |
| Subject information and informed consent form (for publication) | HIP y CI ADIPGEN v1 2 | 1.2 |
| Subject information and informed consent form (for publication) | HIP y CI ADIPGEN v1 3 | 1.3 |
| Subject information and informed consent form (for publication) | HIP y CI ADIPGEN v1 3 control de cambios | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | adrenalina ficha tecnica | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ropivacaina Ficha tecnica | 1 |
| Synopsis of the protocol (for publication) | ADIPGEN sinopsis ENG | 1 |
| Synopsis of the protocol (for publication) | Sinopsis del protocolo ADIPGEN | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-09 | Spain | Acceptable 2026-02-02
|
2026-02-06 |