AnalgesiaAnalgesia PTGNCT07751653
Evaluation of Three Different Antalgic Blocks in Total Knee Prosthesis
A study testing Levobupivacaine in people with Analgesia, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- Levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesItaly
- Study dates
- 6 Aug 2026to 10 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total Knee prosthesis
- ASAC I-II
- signed Informed consent form
Who cannot join
- <40 years
- Mental confusion and delirium
- Coagulation disorders
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 1 recruiting
- Completed
Ospedale Galeazzi S.p.A.
Milan, Italy, 20100
- Recruiting
IRCCS Galeazzi Milano
Milan, Michigan, 20148
Giorgio Oriani G.O. Principal Investigator, Senior Consultant, +39 2 335225452, giorgio.oriani@grupposandonato.it
About this study
Official title: Evaluation of Different Antalgic Blocks in Total Knee Prodthesis
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.
Read the detailed description
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
- Conditions
- Analgesia
- Being tested
- Levobupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Single shot injection at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve, | Active comparator | Femoral nerve block with levo-bupivacaine and Mepivacaine Receives: Drug: Levobupivacaine |
| , Saphenous nerve, | Active comparator | Saphenous nerve at two level, with the same drug composition Receives: Drug: Levobupivacaine |
| , i-pack position | Active comparator | Interspace between popliteal artery and femoral condilus plus low level saphenous, with the same drug Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From surgery until the end of the third day after surgery
Secondary outcomes (1)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start6 Aug 2026
- Primary completion23 Feb 2027 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751653
- Sponsor's protocol ID
- PTG analgesia
- Acronym
- Analgesia PTG
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Antalgic Blocks in Total Knee Prodthesis
- ClinicalTrials.gov ID
- NCT07751653
- Acronym / sponsor ID
- Analgesia PTG / PTG analgesia
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve, | Active comparator | Drug: LevobupivacaineFemoral nerve block with levo-bupivacaine and Mepivacaine |
| , Saphenous nerve, | Active comparator | Drug: LevobupivacaineSaphenous nerve at two level, with the same drug composition |
| , i-pack position | Active comparator | Drug: LevobupivacaineInterspace between popliteal artery and femoral condilus plus low level saphenous, with the same drug |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total Knee prosthesis
- ASAC I-II
- signed Informed consent form
Key exclusion criteria (3 listed)
- <40 years
- Mental confusion and delirium
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineSingle shot injection at the end of surgery | Drug | , Saphenous nerve,, , i-pack position, Femoral nerve, |
Primary outcome
pain, range of motion, weakness and mobilization.
Time frame: From surgery until the end of the third day after surgery
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
1 secondary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine in people with Analgesia, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain, range of motion, weakness and mobilization. (time frame: From surgery until the end of the third day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.