Clinical trial • Not applicable • Neurology|Other

Ropivacaine hydrochloride for Lumbar fusion (lumbar arthrodesis)

Not applicable trial of Ropivacaine hydrochloride for Lumbar fusion (lumbar arthrodesis).

Overview

Trial Therapeutic Area
Neurology|Other
Trial Disease
Lumbar fusion (lumbar arthrodesis)
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-05-2025
First CTIS Authorization Date
07-08-2025

Trial design

Randomised, control arm: 2 infiltrations (bilateral blockade) at the level of the transverse process, volume of 20 ml/side. comparator product recorded: adrenalina b. braun 1 mg/ml solución inyectable (epinephrine). Not applicable trial across 2 sites in Spain.

Randomised
Yes
Comparator
Control arm: 2 infiltrations (bilateral blockade) at the level of the transverse process, volume of 20 ml/side. Comparator product recorded: Adrenalina B. Braun 1 mg/ml Solución Inyectable (epinephrine).
Target Sample Size
62

Eligibility

Recruits 62 No vulnerable populations selected. Inclusion requires Age >18 years and Signed informed consent form; no assent or proxy consent procedures are described..

Vulnerable Population
No vulnerable populations selected. Inclusion requires Age >18 years and Signed informed consent form; no assent or proxy consent procedures are described.

Inclusion criteria

  • {"criterion_text":"- Men and women scheduled for lumbar fusion surgery (maximum of 3 instrumented levels)."}
  • {"criterion_text":"- Age >18 years."}
  • {"criterion_text":"- Signed informed consent form"}

Exclusion criteria

  • {"criterion_text":"- Allergy to local anesthetics."}
  • {"criterion_text":"- Revision lumbar spine surgery."}
  • {"criterion_text":"- Patients with a local infection."}
  • {"criterion_text":"- Patients with connective tissue diseases or vasculitis."}
  • {"criterion_text":"- Chronic pain treated with opioids (Oral Morphine Equivalent Dose > 50 mg/day)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary variable will be intraoperative bleeding in the two study groups, calculated based on the suctioned fluids from the surgical field and the gauzes after extracting the irrigation fluids. Bleeding will be measured in milliliters (ml). The research team will collect the data from the anesthesia record of the procedure.","definition_or_measurement_approach":"Intraoperative bleeding calculated from suctioned fluids from the surgical field and gauzes after extracting irrigation fluids; measured in milliliters (ml); data collected from the anesthesia record of the procedure."}

Recruitment

Planned Sample Size
62
Recruitment Window Months
17
Consent Approach
Signed informed consent required from participants (Age >18). Subject information and informed consent form available (document: L1_SIS and ICF pub). No assent or proxy consent procedures described. Translations/documents available in Spanish.

Geography

Total Number Of Sites
2
Total Number Of Participants
62

Spain

Earliest CTIS Part Ii Submission Date
28-07-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
172
Number Of Sites
2
Number Of Participants
62

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Anesthesiology, Resuscitation and Pain Therapy
Contact Person Name
Mireia Rodríguez Prieto
Contact Person Email
mrodriguezpr@santpau.cat
Site Name
Hospital Quironsalud Murcia
Department Name
Anesthesiology
Contact Person Name
Vicente Roqués

Sponsor

Primary sponsor

Full Name
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Ropivacaína Altan 2 mg/ml solución inyectable EFG
Active Substance
Ropivacaine hydrochloride
Modality
Small molecule
Routes Of Administration
INTRA-ARTICULAR INJECTION
Route
INTRA-ARTICULAR INJECTION
Authorisation Status
Marketing authorisation present (marketingAuthNumber: 75.679, authorisationCountryCode: ES)
Maximum Dose
0.2 % (V/V)
Investigational Product Name
Adrenalina B. Braun 1 mg/ml Solución Inyectable
Active Substance
Epinephrine
Modality
Small molecule
Routes Of Administration
INTRA-ARTICULAR INJECTION
Route
INTRA-ARTICULAR INJECTION
Authorisation Status
Marketing authorisation present (marketingAuthNumber: 68552, authorisationCountryCode: ES)
Maximum Dose
10 µg

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