Comparative study between two groups of patients who underwent ultrasound-guided peripheral nerve blocks to improve postoperative painin the knee arthroplasty

Phase 1

• Conditions: Patients undergoing knee replacement; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-005443-23-ES
• Lead Sponsor: Hospital Sant Joan de Reus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-05
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

The included patients will undergo unilateral primary total knee arthroplasty, aged between 50 and 80 years, ASA I-III, BMI <35 kg / m2, with no previous history of adverse effects and / or allergy to local anesthetics, NSAIDs , metamizole or tramadol, without psychiatric pathology, with correct cognitive capacity, as well as the understanding and written consent of their participation in this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Those patients with indication for primary total knee arthrosplasty with decompensated systemic diseases (hyperthyroidism, severe peripheral vascular disease, diabetics ...), prosthetic replacement surgeries, uncontrolled psychiatric disorders, denial or contraindication to intradural regional anesthesia and peripheral, with a previous history of adverse effects and / or allergy to local anesthetics, NSAIDs, metamizole or tramadol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) To compare the analgesic quality between two groups of patients who underwent bicompartmental unilateral total knee arthroplasty at Hospital Sant Joan de Reus, who will undergo a femoral block, associated or not with a tibial block at the popliteal level whit ropivacaine;Secondary Objective: As secondary objectives:<br><br>2) Evaluate start of rehabilitation. <br>3) Quantify hospital stay.<br>4) Evaluate the postoperative clinical and functional complications.<br> 5) Evaluate patient satisfaction.<br>6) Evaluate opiate use.;Primary end point(s): -Analgesic evaluation according to the EN scale (numerical scale: 0-10);Timepoint(s) of evaluation of this end point: -Analgesic evaluation according to the EN scale (numerical scale: 0-10) in the immediate postoperative period, upon discharge from the URPA (postanesthetic recovery unit), 6-12-24-36 and at 48 hours, at rest and in motion, considering mild pain less than or equal to 3, moderate from 4 to 6 and severe greater than 7.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Demographic: age, sex and BMI (weight and height).<br>- ASA (I-III).<br>- Assessment of functionality in basic activities: preoperative Barthel index. <br>- Surgical time in minutes.<br>- Ischemia time in minutes.<br>- Type of knee prosthesis.<br>- Assessment of motor and sensitive block in URPA. Reversion time.<br>- Consumption of postoperative analgesia in the first 48h.<br>- Time elapsed until the first rescue analgesic.<br>- Postoperative pharmacological and technical complications and side effects.<br>- Rehabilitation start at 24h.<br>- Assessment of risk of falling: Tinetti scale at 24 hours after surgery and before discharge.<br>- Days of hospital stay.<br>- Overall patient satisfaction at discharge: very satisfied, acceptable or dissatisfied. <br>- Would you repeat the technique performed? YES/NO;Timepoint(s) of evaluation of this end point: Patient control during the first 48 postoperative hours