Analgesia
Conditions
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.
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
Interventions
DRUGLevobupivacaine
Single shot injection at the end of surgery
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Total Knee prosthesis * ASAC I-II * signed Informed consent form
Exclusion criteria
* \<40 years * Mental confusion and delirium * Coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed