Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia

Study Overview
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Brief Summary
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In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components. In this randomized trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the hypothesis that PENG block will result in significantly less motor block compared to SFIB.

Official Title
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A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement

Conditions
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Postoperative Complications, Postoperative Pain, Weakness, Muscle, Motor Activity

Intervention / Treatment
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* Procedure: Ultrasound-guided suprainguinal fascia iliaca nerve block
* Procedure: Ultrasound-guided pericapsular nerves group of the hip block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 years American Society of Anesthesiologists classification 1-3 Body mass index between 20 and 35 (kg/m2) Exclusion Criteria: Adults who are unable to give their own consent Pre-existing neuropathy (assessed by history and physical examination) Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤a100, International Normalized Ratio ≥01.4 or prothrombin time ≥ 50) Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) Allergy to local anesthetics (LAs) Pregnancy Prior surgery in the corresponding side of the inguinal or suprainguinal area Chronic pain syndromes requiring opioid intake at home

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized comparison between two analgesic techniques
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: suprainguinal fascia iliaca block<br>Forty mL of levobupivacaine 0.25% with epinephrine 5 ug/mL will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle. | Procedure: Ultrasound-guided suprainguinal fascia iliaca nerve block<br>* After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.<br>|
| Experimental: Pericapsular nerve group block<br>Twenty mL of levobupivacaine 0.5% with epinephrine 5 ug/mL will be deposited in the anterior aspect of the iliac bone between its periosteum and the tendon of the iliopsoas muscle. | Procedure: Ultrasound-guided pericapsular nerves group of the hip block<br>* After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of quadriceps motor block (defined as paralysis or paresis). | Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension). | 6 hours after block performance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block performance time | temporal interval between the start of skin disinfection and the end of LA injection through the block needle | 1 hour after surgery | 
| Static and dynamic pain | Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 3 hours after the block | 
| Static and dynamic pain | Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 6 hours after the block | 
| Static and dynamic pain | Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 12 hours after the block | 
| Static and dynamic pain | Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 18 hours after the block | 
| Static and dynamic pain | Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 24 hours after the block | 
| Static and dynamic pain | Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 36 hours after the block | 
| Static and dynamic pain | Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 48 hours after the block | 
| Postoperative morphine consumption | consumption of intravenous morphine registered by a patient controlled analgesia device | 24 hours after the block | 
| Postoperative morphine consumption | consumption of intravenous morphine registered by a patient controlled analgesia device | 48 hours after the block | 
| Sensory block | Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch) | 3 hours after the block | 
| Sensory block | Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch) | 6 hours after the block | 
| Sensory block | Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch) | 24 hours after the block | 
| Presence of quadriceps motor block (defined as paralysis or paresis). | Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension). | 3 hours after the block | 
| Presence of quadriceps motor block (defined as paralysis or paresis). | Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension). | 24 hours after the block | 
| Hip adduction strength. | Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively. | 3 hours after the block | 
| Hip adduction strength. | Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively. | 6 hours after the block | 
| Hip adduction strength. | Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively. | 24 hours after the block | 
| Block-related complications | vascular puncture, paresthesia or systemic local anesthetic toxicity | 1 hour after the block | 
| Postoperative opioid related side effects | Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression | 48 hours after the block | 
| Inability to perform physiotherapy due to motor block | Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated leg. | Postoperative day 1 | 
| Inability to perform physiotherapy due to motor block | Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg. | postoperative day 2 | 
| Inability to perform physiotherapy due to pain | Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated leg. | postoperative day 1 | 
| Inability to perform physiotherapy due to pain | Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg. | postoperative day 2 |