Which Analgesia is Better for Proximal Femoral Fractures?

Study Overview
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Brief Summary
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This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes. Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.

Detailed Description
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The aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery. Fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control. A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves, but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported The high articular branches from FN and AON are consistently found between the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum. The ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline. Roy et al 2019 recommended the use of PENG block together with LFCN block as adjunctive to cover the lateral surgical incision.

Official Title
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- Efficacy of Combined Lateral Femoral Cutaneous Nerve Block With Pericapsular Nerve Group Block Versus Fascia Iliaca Block in Proximal Femoral Fractures

Conditions
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Proximal Femur Fracture

Intervention / Treatment
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* Procedure: Fascia iliaca block
* Procedure: combined LFCN block with PENG block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I, II and III. Exclusion Criteria: Patient refusal. Neuromuscular diseases Hematological diseases Bleeding abnormality Coagulation abnormality. Psychiatric diseases. Local skin infection at the site of the block. Local skin sepsis at the site of the block Known intolerance to the study drugs. Body Mass Index > 40 Kg/m2. Multiple trauma patients.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fascia iliaca block<br>Patients will receive Fascia iliaca block | Procedure: Fascia iliaca block<br>* A linear probe will be placed in the sagittal plane to the inguinal ligament to obtain an image of bow-tie sign formed by the muscle fascias, a spinal needle will be inserted 1 cm cephalad Using an in-plane approach, the fascia iliaca is penetrated, 30 mL of bupivacaine 0.25% before spinal anesthesia.<br>|
| Active Comparator: combined LFCN block with PENG block<br>Patients will receive a combined lateral femoral cutaneous nerve block with pericapsular nerve group block | Procedure: combined LFCN block with PENG block<br>* With the patient supine, the linear probe is placed parallel to the inguinal ligament. LFCN appear as a hypoechoic oval structure between the tensor fascia lata and Sartorius muscles. The needle is inserted in plane. 5 mL of LA is injected. The PENG block will be performed in the supine position. A curvilinear probe will be placed transversely over the anterior inferior iliac spine and then rotated counterclockwise 45 degrees. the ilio pubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A spinal needle will be inserted in plane to the plane between the psoas tendon and the pubic ramus. 25 mL of bupivacaine 0.25% will be injected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of performance of Spinal Anesthesia | Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection | just before surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement at rest | 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain | immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery. | 
| Pain measurement on movement | (attempted hip flexion to 15 degrees).: 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain | immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery. | 
| Pain measurement during positioning for spinal anesthesia | visual analog scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to sitting one | Just before surgery | 
| The severity of postoperative pain at rest | 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain | immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery. | 
| The severity of postoperative pain on movement | (attempted hip flexion to 15 degrees): 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain | immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery. | 
| Time to onset of Sensory blockade | cold perception loss in the lateral, anterior and medial part of the thigh (corresponding to lateral femoral cutaneous (LFC), femoral (F) and obturator (O)nerve sensory distributions, respectively) | evaluated 15 and 30 min after block administration | 
| Time to onset of motor block | defined as assessment of quadriceps femoris muscle strength by straight leg raise test to 15 degree and classified as follow: +ve =normal power, -ve =motor weakness | evaluated 15 and 30 min after block administration | 
| Duration of sensory block | blockade is defined as the interval between end of injection and complete end of sensory block (score=2) | postoperative 24 hours | 
| Duration of motor block | blockade is defined as the interval between end of injection and complete end of injection and complete recovery of normal motor function (score=0), | postoperative 24 hours | 
| Anesthesiology satisfaction for patient positioning | evaluated as 0=unsatisfactory, 1=satisfactory, 2=good or 3=optimal | just before surgery | 
| heart rate | Changes in heart rate | pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery | 
| Mean arterial blood pressure | Changes in Mean arterial blood pressure | pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery | 
| Peripheral oxygen saturation | Changes in peripheral oxygen saturation as measured with pulse oximetry | pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery | 
| Time for first analgesic request | defined as the time period from end of injection to the first time patient requests analgesia postoperatively | Within 24 hours after surgery | 
| Total analgesics received | cumulative consumption of opioids during the first postoperative day | for 24 hrs after surgery | 
| Pruritis | number of patients with pruritis | Within 24 hours after surgery | 
| nausea | number of patients with nausea | Within 24 hours after surgery | 
| vomiting | number of patients with vomiting | Within 24 hours after surgery |