Clinical trial • Not applicable • Musculoskeletal
LEVOBUPIVACAINE for Total hip arthroplasty
Not applicable trial of LEVOBUPIVACAINE for Total hip arthroplasty.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Total hip arthroplasty
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 21-11-2023
- First CTIS Authorization Date
- 15-03-2024
Trial design
Test: Levobupivacaína Altan 2,5 mg/ml solución inyectable y para perfusión EFG (active substance: LEVOBUPIVACAINE), max total dose 62.5 mg, route: perineural use. Comparator/Placebo: Suero Fisiológico Braun 0,9% (sodium chloride), max total dose 25 ml, route: perineural use.-controlled Not applicable trial in Spain.
- Comparator
- Test: Levobupivacaína Altan 2,5 mg/ml solución inyectable y para perfusión EFG (active substance: LEVOBUPIVACAINE), max total dose 62.5 mg, route: perineural use. Comparator/Placebo: Suero Fisiológico Braun 0,9% (sodium chloride), max total dose 25 ml, route: perineural use.
- Target Sample Size
- 64
- Trial Duration For Participant
- 366
Eligibility
Recruits 64 Vulnerable population not selected (isVulnerablePopulationSelected=false); participants must sign informed consent ("sign the informed consent"). No assent or paediatric consent arrangements specified..
- Pregnancy Exclusion
- Women of reproductive age without contraceptive control, maternity or breastfeeding
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false); participants must sign informed consent ("sign the informed consent"). No assent or paediatric consent arrangements specified.
Inclusion criteria
- {"criterion_text":"- Patients scheduled for primary hip replacement who agree to participate in the study and sign the informed consent"}
Exclusion criteria
- {"criterion_text":"- Refusal to participate in the study"}
- {"criterion_text":"- blood coagulation dysfunction"}
- {"criterion_text":"- Neuropathies"}
- {"criterion_text":"- Punction site or systemic infections"}
- {"criterion_text":"- Local anesthestic alergies"}
- {"criterion_text":"- Women of reproductive age without contraceptive control, maternity or breastfeeding"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Pain","definition_or_measurement_approach":""}
- {"endpoint_text":"- Quadriceps muscular strength","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Adverse effects: Nausea, vomiting, sedation, toxicity, others","definition_or_measurement_approach":""}
- {"endpoint_text":"- Opioid consumption","definition_or_measurement_approach":""}
- {"endpoint_text":"- Need for additional analgesia","definition_or_measurement_approach":""}
- {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":""}
- {"endpoint_text":"- Pain experience","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 12
- Consent Approach
- Participants must sign informed consent ('sign the informed consent'). No assent or paediatric consent procedures or languages specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 64
Spain
- Earliest CTIS Part Ii Submission Date
- 26-01-2024
- Latest Decision Or Authorization Date
- 04-07-2024
- Processing Time Days
- 160
- Number Of Sites
- 1
- Number Of Participants
- 64
Sites
- Site Name
- Parc De Salut Mar
- Department Name
- Anestesiología
- Principal Investigator Name
- Xavier Santiveri
- Principal Investigator Email
- fsantiveri@psmar.cat
- Contact Person Name
- Xavier Santiveri
- Contact Person Email
- fsantiveri@psmar.cat
- Number Of Participants
- 64
Sponsor
Primary sponsor
- Full Name
- Hospital Del Mar
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Levobupivacaína Altan 2,5 mg/ml solución inyectable y para perfusión EFG
- Active Substance
- LEVOBUPIVACAINE
- Modality
- Small molecule
- Routes Of Administration
- PERINEURAL USE
- Route
- Perineural
- Authorisation Status
- Authorised (marketing authorisation number 78240, country ES)
- Maximum Dose
- 62.5 mg
- Investigational Product Name
- Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- PERINEURAL USE
- Route
- Perineural
- Authorisation Status
- Authorised (marketing authorisation number 58449, country ES)
- Maximum Dose
- 25 ml
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