Equivalence study for a comparison of the impact on postoperative functional recovery in total hip arthroplasty between periarticular infiltration, pericapsular nerve group block (PENG), and suprainguinal iliaca fascia block

Phase 1

Conditions: Total hip arthroplasty surgery
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2022-002250-97-BE

Lead Sponsor: CHU de Liège

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 219

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures