Lateral Cutaneous Nerve and PENG Blocks Versus Suprainguinal Fascia Iliaca Block in Post-op Analgesia of Hip Fractures

Study Overview
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Brief Summary
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Postoperative pain in hip fractures is challenging and requires adequate management. Peripheral nerve blocks are already known as superior than systemic analgesia in this scenario, but the best analgesic regional technique is still unknown. The investigators propose a study to compare the postoperative analgesia of hip fractures between pericapsular nerve group block plus lateral femoral cutaneous nerve block and suprainguinal fascia iliaca block

Detailed Description
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Postoperative pain in hip fractures is challenging and requires adequate management. In this scenario, peripheral nerve blocks present superior results to systemic analgesia, minimizing the use of opioids and their adverse effects. The lumbar plexus is responsible for the nociception of the hip joint through the femoral, obturator, and accessory obturator nerves, besides being responsible for the sensory innervation of the lateral aspect of the thigh through the lateral femoral cutaneous nerve. Due to this intricate network, several regional techniques have already been proposed. However, the best analgesic approach is still unknown. Ultrasound-guided suprainguinal fascia iliaca block (SIFIB), which addresses the femoral and lateral femoral cutaneous nerves, and ultrasound-guided pericapsular nerve group block (PENG), which addresses terminal branches of the femoral and accessory obturator nerves, are techniques currently used successfully in the context of analgesia for hip surgery. PENG block generates less motor impairment of the quadriceps, which can be significant in terms of mobility and rehabilitation. Both techniques show similar analgesic results in the still scarce literature, but SIFIB has shown slight advantage in some scenarios. However, the PENG block does not reach the lateral cutaneous nerve, which may lead to greater postoperative pain perception. In an attempt to fill this knowledge gap, the investigators propose a study to analyze whether the association between PENG block and lateral femoral cutaneous nerve block (LFCNB) promotes postoperative analgesia equal to SIFIB in a population of adults with hip fractures. This will be a prospective, controlled, randomized, double blind study. Patients with hip fractures (femoral neck, transtrochanteric and subtrochanteric) who will undergo surgical treatment (hip arthroplasty and osteosynthesis with intramedullary nails or screws) will be recruited and randomly allocated into two groups: control (C) and experimental (E). In group C, patients will undergo SIFIB with 30 ml of 0.5% ropivacaine, and to maintain blinding they will also undergo PENG and LFCNB with 20 ml and 10 ml of saline, respectively. In group E, patients will receive the PENG block associated with LFCNB, with 20ml + 10ml of 0.5% ropivacaine, respectively, and 30 ml of saline solution in the SIFIB. After performing the blocks, all patients will undergo spinal anesthesia, with intrathecal injection of 10mg of 0.5% isobaric bupivacaine. As a primary objective, the investigators will evaluate dynamic pain (passive elevation of the leg at 15°) using the Numeric Rating Scale (0-10), 6 hours, 12 hours and 24 hours after spinal anesthesia.

Official Title
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Lateral Femoral Cutaneous Nerve and Pericapsular Nerve Group (PENG) Blocks Versus Suprainguinal Fascia Iliaca Block in Postoperative Analgesia of Hip Fractures: a Prospective, Controlled, Randomized and Double Blind Study

Conditions
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Anesthesia, Conduction

Intervention / Treatment
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* Drug: Ropivacaine + saline solution
* Drug: Saline solution + Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hip fractures who will undergo surgical treatment. Adults over 18 years. American Society of Anesthesiology physical status 1 to 3. Body mass index (BMI) < 35 Kg/m2. Exclusion Criteria: Local anesthetic allergy Coagulopathy American Society of Anesthesiology physical status ≥ 4, Dementia Peripheral polyneuropathy Pregnancy Chronic opioid use (> 3 months) BMI >35 Kg/m2 Stroke with lower limb motor sequelae Patient refusal/withdrawal Those whose spinal anesthesia has been changed to general anesthesia.

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: Prospective, controlled, randomized and double blind
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suprainguinal Fascia Iliaca Block Group<br>Patients will undergo SIFIB with ropivacaine and PENG plus LFCNB with saline solution. | Drug: Ropivacaine + saline solution<br>* SIFIB with 30 ml of 0.5% ropivacaine and PENG Block plus LFCNB with 20 ml and 10 ml of saline solution, respectively.<br>* Other names: Naropin + saline solution;|
| Experimental: PENG Block + Lateral Femoral Cutaneous Nerve Block Group<br>Patients will undergo SIFIB with saline solution and PENG plus LFCNB ropivacaine. | Drug: Saline solution + Ropivacaine<br>* SIFIB with 30 ml of saline solution and PENG Block plus LFCNB with 20 ml and 10 ml of 0,5% ropivacaine, respectively.<br>* Other names: Saline solution + Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Post-op Hip Pain | To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain). | 6 hours after spinal anesthesia. | 
| Dynamic Post-op Hip Pain | To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain). | 12 hours after spinal anesthesia | 
| Dynamic Post-op Hip Pain | To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain). | 24 hours after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op Hip Pain at Rest | To evaluate hip pain at rest in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from ) (no pain) to 10 (worst possible pain).. | 6 hours, 12 hours and 24 hours after spinal anesthesia. | 
| Quadriceps muscle strength measured by dynamometry in newton (N). | To test the quadriceps muscle strength by dynamometry (Med Force hand-held push dynamometer, tHHD, MED.DOR Ltd., Governador Valadares, Brazil) in newton. | 6 hours, 12 hours and 24 hours after spinal anesthesia. | 
| Quadriceps muscle strength index | To calculate quadriceps muscle strength index by the ratio between the strengths (collected by dynamometry) of the non-operated and operated lower limbs. | 6 hours, 12 hours and 24 hours after spinal anesthesia. | 
| Total intravenous morphine dose in milligram over 24 hours | To quantify the total rescue morphine dose (or morphine equivalent) in mg over 24h. | 24 hours | 
| Time of the first morphine order in minutes | To record the time of the first morphine order in minutes after the spinal anesthesia | 24 hours | 
| Incidence of opioid side effects | To record the incidence of opioid side effects - nausea/vomiting, pruritus, urinary retention and respiratory depression | 24 hours | 
| Incidence of blockades complications | To record the incidence of blockades complications - vascular puncture, hematoma, local anesthetic toxicity and nerve injury. | 24 hours | 
| Incidence of delirium | To evaluate altered cognition and conclude as positive or negative. | 24 hours |