Periarticular Infiltration of Local Anesthetics Versus Pericapsular Nerve Group Block for Total Hip Replacement

Study Overview
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Brief Summary
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This randomized trial is set out to compare the postoperative strength preservation capacity of local infiltration anesthesia (LIA) and pericapsular nerve group (PENG) block after performing a primary total hip arthroplasty (THA). The hypothesis is that LIA represents a superior alternative to PENG block in terms of strength preservation but providing effective analgesia during the first 24 postoperative hours after THA. Hence, the trial was designed as a superiority study hypothesizing a fivefold reduction in quadriceps paresis/paralysis at 3 hours.

Detailed Description
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Patients who agree to participate in the protocol will be assigned to one group or another (LIA and PENG) through computationally generated block randomization. Outcome assessors blinded to randomization will perform all measurements. All blocks, LIA or PENG, will be performed (or supervised) by one of the co-authors, an expert orthopedic surgeon or an expert anesthesiologist, respectively. Both blocks will be executed in the operating room, on the surgical table, under sedation, and with the barrier that separates the surgical field from the cranial area of the patient to keep the latter blind to the technique received. All patients will undergo spinal anesthesia using 0.5% bupivacaine (10mg) plus 20 μg of fentanyl. Both groups will also receive tranexamic acid 1g intravenous (IV), ketoprofen 100mg IV, and acetaminophen 1gr IV. Propofol sedation guided with a targeted controlled infusion (TCI) model will be administered in order to obtain an adequate level of sedation. All surgeries will be conducted by the same team of surgeons, performing a posterior approach technique in the lateral decubitus position. In the recovery room, all patients will receive patient-controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (1 g per os every 6 hours), ketoprofen (100 mg per os every 8 hours) as well and patient-controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).

Official Title
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A Randomized Comparison Between Periarticular Infiltration of Local Anesthetics and Ultrasound-Guided Pericapsular Nerve Group Block for Total Hip Replacement

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

Intervention / Treatment
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* Procedure: Ultrasound-guided pericapsular nerves group of the hip block
* Procedure: Pericapsular local anesthetic infiltration of the hip


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 ≤ 100, 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) or morphine Pregnancy Prior surgery in the inguinal area of the corresponding surgical side Previous hip arthroplasty due to hip fracture 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pericapsular nerve group block<br>Twenty milliliters of bupivacaine 0.5% (100 milligrams) 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. Additionally, ketorolac 30 mg will be administered intravenously. | Procedure: Ultrasound-guided pericapsular nerves group of the hip block<br>* After the ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between the iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% bupivacaine.<br>|
| Experimental: Periarticular local anesthetic infiltration<br>Sixty milliliters of 0.25% bupivacaine (150 milligrams), 5ug/mL epinephrine, and ketorolac 30 mg will be deposited at the periarticular level under direct vision during surgery. Fascia, subcutaneous tissues, and skin will also be infiltrated with part of the solution before wound closure. | Procedure: Pericapsular local anesthetic infiltration of the hip<br>* Intraoperatively, 60 mL of adrenalized 0.25% bupivacaine plus ketorolac 30 mg will be infiltrated by the surgeon.<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 lying on the bed and with the hip joint at 45º and the knee at 90º. 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 post anesthesia care unit (PACU) arrival | 

Secondary 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 lying on the bed and with the hip joint at 45º and the knee at 90º. 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 PACU arrival | 
| Presence of quadriceps motor block (defined as paralysis or paresis) | Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. 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 PACU arrival | 
| 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% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively. | 3 hours after PACU arrival | 
| 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% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively. | 6 hours after PACU arrival | 
| 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% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively. | 24 hours after PACU arrival | 
| Postoperative morphine consumption | Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device. | 24 hours after PACU arrival | 
| Postoperative morphine consumption | Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device. | 48 hours after PACU arrival | 
| Time until first morphine demand | Time (minutes) until first patient-controlled analgesia morphine demand. | 48 hours after PACU arrival | 
| Static and dynamic pain | Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 3 hours after PACU arrival | 
| Static and dynamic pain | Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 6 hours after PACU arrival | 
| Static and dynamic pain | Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 12 hours after PACU arrival | 
| Static and dynamic pain | Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 18 hours after PACU arrival | 
| Static and dynamic pain | Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 24 hours after PACU arrival | 
| Static and dynamic pain | Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain) | 48 hours after PACU arrival | 
| 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 PACU arrival | 
| 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 PACU arrival | 
| 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 PACU arrival | 
| Block/Infiltration-related complications | Incidence of adverse events related to nerve block or local anesthetic infiltration (i.e. vascular puncture, local anesthetic systemic toxicity) | 1 hour after nerve block or local anesthetic infiltration | 
| Postoperative opioid related side effects | Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression. | 48 hours after PACU arrival | 
| Duration of surgery | Time between skin incision and closure (min) | 4 hours after skin incision | 
| Inability to perform physiotherapy due to motor block | Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to decreased strength in the operated limb. | 6 hours after PACU arrival | 
| 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 limb. | 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 limb. | Postoperative day 2 | 
| Inability to perform physiotherapy due to pain | Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to pain in the operated limb. | 6 hours after PACU arrival | 
| 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 limb. | 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 limb. | Postoperative day 2 | 
| Readiness to discharge | Days to be ready for discharge following physiotherapist criteria | 4 days after surgery | 
| Length of hospital stay | Length of hospital stay after surgery | 7 days after surgery |