Total hip arthroplasty surgery
Conditions
Interventions
Trade Name: Naropin
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Ropivacaine
Other descriptive name: Ropivacaine hydrochloride
Concentration unit: mg/ml milligram(s)/milli
Sponsors
CHU de Liège
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be recruited during the preoperative anesthesia consultation. They will have to be of age (> 18 years old), classified in the categories American Society of Anesthesiologists (ASA) 1-2-3, admitted for a programmed total hip arthroplasty surgery with spinal anesthesia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 119
Exclusion criteria
Exclusion criteria: Excluded from the study are pregnant women, patients with peripheral neuropathy or other severe neurological pathology, chronic pain syndromes, chronic renal insufficiency or severe hepatic insufficiency, allergy to local anaesthetics, major haemostasis disorders or opioid addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of our study is to evaluate the equivalence of supra-inguinal fascia iliaca block to pericapsular nerve group block and periarticular infiltration in 2-minute walk test (2MWT) performance at 24 hours after the intervention.;Secondary Objective: We expect supra-inguinal fascia iliaca block (SFIB) block to be equivalent to pericapsular nerve group (PENG) block and periarticular infiltration in postoperative functional performance, without motor and quadriceps femoral impairment and with equivalent postoperative analgesia. If the hypothesis is correct, we could propose to integrate SFIB or PENG as first line in the postoperative analgesia strategy for this surgery.;Primary end point(s): The primary endpoint will be the assessment of performance on the 2-minute walking test;Timepoint(s) of evaluation of this end point: At 24 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Consumption of morphine equivalents: oral administration of oxycodone - The distance in meters covered in the 2-minute walk test - Distance in meters covered in the 6-minute walk test - Timed Up-and-Go (TUG) test - Numerical rating scale (NRS) of pain - Postoperative complications such as: 1. Orthostatic intolerance 2. Falls 3. Postoperative nausea and vomiting 4. Morphine-related side effects: bladder globe, constipation, dizziness and drowsiness - Tampa-scale for the measurement of kinesiophobia - Quality-of-Recovery 15-item score (QoR-15) to assess functional recovery - Analysis of quadriceps strength before and after the intervention using the dynamometer for isometric contraction - Analysis with the Inertial Measurment Units (IMUs) system with accelerometer technology and angular acceleration measurement;Timepoint(s) of evaluation of this end point: - Opioid consumption: first 24 hours postoperatively - 2-minute walk test: second postoperative day (D2). - Timed Up-and-Go (TUG) test and 6-minute walk test on the first (D1) and second (D2) day after surgery - NRS of pain at fixed times: 6h and 12h after surgery, at D1 at 8h, 13h and 18h. First 48 hours for postoperative complications Tampa-scale for the measurement of kinesiophobia at D2 Quality-of-Recovery 15-item score (QoR-15) to assess functional recovery on day-2 and day-30 Analysis of quadriceps strength before and after the intervention using the dynamometer for isometric contraction at D1 and D2 Analysis with the Inertial Measurment Units (IMUs) system with accelerometer technology and angular acceleration measurement at D1 and D2 | — |
Countries
Belgium
Contacts
Public ContactMichele Carella
CHU de Liège
Outcome results
None listed