An interventional study of Levobupivacaine in Analgesia, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 2 sites in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Not applicable, Interventional, and Supportive care
This randomised trial examines the three main anaesthetic blocks used in knee replacement surgery, comparing them in terms of analgesic efficacy (primary outcome), range of motion and degree of flexion in the immediate post-operative period.
Other outcomes include medication use and an analysis of any differences based on sex and age.
The three groups, each comprising 47 patients for a total of 141 patients, were randomly assigned and followed up in a 'double-blind' evaluation; they include patients meeting the following criteria Inclusion criteria are Both sexes, Unilateral knee prosthesis, Age > 40 years Informed consent
Exclusion criteria are:
Severe medical conditions and coagulation disorders Lack of cooperation Absence of informed consent Unicompartmental and/or bilateral prostheses
Patients will be monitored for the first 3 days of their hospital stay, and will then be followed up by telephone at 30 days.
All data will be recorded in a dedicated case report form and subsequently analysed and evaluated
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Femoral nerve block with levo-bupivacaine and Mepivacaine
Drug: Levobupivacaine
Saphenous nerve at two level, with the same drug composition
Drug: Levobupivacaine
Interspace between popliteal artery and femoral condilus plus low level saphenous, with the same drug
Drug: Levobupivacaine
Single shot injection at the end of surgery
pain, range of motion, weakness and mobilization.
Primary outcome is pain evaluation. We willi use NRS scale, that's Numeric Scale Rating, with value between "0" and "10" where "0" means no pain and "10" the maximum possible pain. This evaluation should be repeated on day of surgery and after, creating a real "value report" The other primary outcome is a change in ROM (range of movement). For this measure we will use a goniometer to evaluate ROM. This goniometer allows us to measure the degree of Movement , starting from "0" and "120" degree. This values shlould be measured at day of surgery and more for the first three days after surgery
Time frame: From surgery until the end of the third day after surgery
Motility, evaluated by a Physician (blind on kind of antalgic block) at day "0" (surgery day) and more on 1st - 2nd and Third day after surgery. Presence of any complication (fever, weakness, limitation in movements
This secondary outcome are important to evaluate recovery and difference between age, sex, BMI, lenght of stay
Time frame: From surgery until third day and, as follow up, 15 and 30 days after surgery. The follo up will be performed, by phone calla, at 15 and 30 days after discharge
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2027, 6 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: start Feb 2025 → Aug 2026, primary completion Oct 2025 → Feb 2027 and completion May 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Levobupivacaine
Agnosia
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio →