Evaluation of Three Different Antalgic Blocks in Total Knee Prosthesis

NCT07751653 — Not applicable, Completed, 141 participants, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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Evaluation of Different Antalgic Blocks in Total Knee Prodthesis

Registry	NCT07751653, acronym Analgesia PTG
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	141 (Actual)
Sponsor	I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio (Other)
Conditions	Analgesia
Interventions	Levobupivacaine (Drug)
Dates	start 2025-02-06, primary completion 2025-10-23, completion 2026-05-10, first posted 2026-08-07, last updated 2026-09-14
Locations	1 site in Italy

-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.

Other outcomes include medication use and an analysis of any differences based on sex and age.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Femoral nerve,	Active comparator	Drug: Levobupivacaine	Femoral nerve block with levo-bupivacaine and Mepivacaine
, Saphenous nerve,	Active comparator	Drug: Levobupivacaine	Saphenous nerve at two level, with the same drug composition
, i-pack position	Active comparator	Drug: Levobupivacaine	Interspace between popliteal artery and femoral condilus plus low level saphenous, with the same drug

Levobupivacaine (Drug): Single shot injection at the end of surgery

+Outcome measures

Primary outcomes

pain, range of motion, weakness and mobilization. [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

Secondary outcomes

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 [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]: This secondary outcome are important to evaluate recovery and difference between age, sex, BMI, lenght of stay

+Eligibility

Sex: All, ages: 40 Years to any

Inclusion Criteria:

* Total Knee prosthesis
* ASAC I-II
* signed Informed consent form

Exclusion Criteria:

* <40 years
* Mental confusion and delirium
* Coagulation disorders

+Locations (1)

Facility	City	Country	Status
Ospedale Galeazzi S.p.A.	Milan, Italy	Italy