Comparison of PENG Associated With LFCN Block Versus FICB for Multimodal Analgesic Management in THA

Study Overview
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Brief Summary
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Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FIC) has been recommended since it offers the best pain control with low risk of motor block. Pericapsular nerve group block (PENG) with lateral femoral cutaneous block (LFCN) has been proposed as an effective alternative to FIB that offers similar pain control with a considerably lower risk of motor block. The aim of this study is to compare the afore mentioned blocks and determine which one yielded the least degree of quadriceps femoris muscle weakness and the better pain control (the lowest NRS score with least need for opioids).

Detailed Description
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This single-center, double blinded RCT investigation will be conducted at ASST Nord Milano - Bassini hospital. The study was approved by the ethics committee Comitato Etico Territoriale Lombardia 3. Each patient undergoing elective total hip replacement surgery with lateral approach will be subjected (unless contraindicated) to subarachnoid neuraxial anesthesia and immediately afterwards to a peripheral analgesic block: the FIC block or the association of PENG and FCLN block. The choice of block type will be randomized. At the end of the procedure, a clinician unaware of the anesthetic technique used will assess the degree of residual motor block. Simultaneously, he will assess pain control in terms of NRS (Numerical Rating Scale) and the need for opioid use.

Official Title
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Comparison of Pericapsular Nerve Group (PENG) Block Associated With Lateral Femoral Cutaneous Nerve (LFCN) Block Versus Fascia Iliaca Compartment Block (FICB) for Multimodal Analgesic Management in Total Hip Replacement Surgery: a Double-blinded Randomized Controlled Trial

Conditions
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Regional Anesthesia Morbidity, Arthropathy of Hip, Hip Arthropathy, Post Operative Pain, Anesthesia Complication

Intervention / Treatment
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* Procedure: PENG plus LFCN block
* Procedure: FIC Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective total hip replacement surgery for non-traumatic hip disease, THA (total hip arthroplasty) with lateral approach age >18 years, signed consent form for spinal anesthesia and peripheral nerve block provided by the patient or legal guardian if appointed Exclusion Criteria: Non elective THA Lack of consent to the procedure Contraindications to performing neuraxial anesthesia (i.e. Signs suggestive of puncture site infection, INR > 1.5, aPTT > 1.5, PLT < 40.000) Documented or suspected allergy to local anesthetics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind, randomized, controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENG - LFCN Block<br>group in which PENG and LFCN Block was performed. After performing neuraxial anesthesia, the PENG associated with LFCN block will be performed. Under ultrasound guidance, 20ml and 5ml of Ropivacaine 0.5% will be administered respectively. | Procedure: PENG plus LFCN block<br>* The experimental arm will be subjected to a combination of peripheral blocks: the interfascial block of the PENG and the perinervous block of the LFCN The PENG block involves deposition of local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. The LFCN block consists of applying local anesthetic near the nerve. The LFCN lies in the subcutaneous plane deep to the fascia lata below the anterior superior ischiatic spine.<br>* Other names: PENG and lateral femoral cutaneous nerve block;|
| Active Comparator: FIC Block<br>group in which FIC Block was performed After performing neuraxial anesthesia, FIC block will be performed. Under ultrasound guidance, 20 ml of Ropivacaine 0.5% will be administered. | Procedure: FIC Block<br>* The control arm will be subjected to an interfascial block, the fascia iliaca Compartment Block. The FICB consists in the injection of anaesthetic agents into the fascia iliaca compartment.<br>* Other names: FICB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRC at 6h | evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning no contraction  and five meaning Full range of motion against gravity with full resistance. | six hours after performing the regional anesthesia technique | 
| MRC at 24h | evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning no contraction  and five meaning Full range of motion against gravity with full resistance. | 24 hours after performing the regional anesthesia technique | 
| MRC at 48h | evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning no contraction  and five meaning Full range of motion against gravity with full resistance. | 48 hours after performing the regional anesthesia technique | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first postoperative ambulation | we studied the effect or Regional anesthesia on residual paralysis | From date of surgery until up to 72 hours after | 
| Pain control at 6h | pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | six hours after performing the regional anesthesia technique | 
| Pain control at 24h | pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | 24 hours after performing the regional anesthesia technique | 
| Pain control at 48h | pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | 48 hours after performing the regional anesthesia technique | 
| MME of PRN opioid total doses | Morphine Milligram Equivalents (MME) of pro re nata (PRN) opioid total doses we will study the effect of Regional anesthesia on opioid-sparing with the same pre-established pain relief protocol | From date of surgery until up to 72 hours after | 
| time to first PRN opioid request | time to first PRN (pro re nata) opioid request expressed in minutes | From date of surgery until up to 72 hours after | 
| need for PRN opioid | number of opioid administration | From date of surgery until up to 72 hours after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Postoperative muscle weakness, Regional Block, Post Operative Analgesia