Evaluation of Three Different Antalgic Blocks in Total Knee Prosthesis

NCT07751653 | Completed

• 1 other identifier: PTG analgesia
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

Study Arms (3)

Femoral nerve,

ACTIVE COMPARATOR

Femoral nerve block with levo-bupivacaine and Mepivacaine

Drug: Levobupivacaine

, Saphenous nerve,

ACTIVE COMPARATOR

Saphenous nerve at two level, with the same drug composition

Drug: Levobupivacaine

, i-pack position

ACTIVE COMPARATOR

Interspace between popliteal artery and femoral condilus plus low level saphenous, with the same drug

Drug: Levobupivacaine

Interventions

Levobupivacaine DRUG

Single shot injection at the end of surgery

, Saphenous nerve,; , i-pack position; Femoral nerve,

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<40 years
• Mental confusion and delirium
• Coagulation disorders

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Ospedale Galeazzi S.p.A.

Milan, Italy, 20100, Italy

Location

MeSH Terms

Conditions

Agnosia

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: August 7, 2026
• Study Start: February 6, 2025
• Primary Completion: October 23, 2025
• Study Completion: May 10, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)