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Completed

NCT Number: NCT07751653

Evaluation of Three Different Antalgic Blocks in Total Knee Prosthesis

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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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Galeazzi S.p.A.

Milan, Italy, 20100

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Levobupivacaine plus mepivacaine

Drug

Single shot injection at the end of surgery

Primary outcomes

  1. 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

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

    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

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

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

Evaluation of Different Antalgic Blocks in Total Knee Prodthesis

Acronym: Analgesia PTG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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