Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery

Study Overview
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Brief Summary
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Evaluation of the combination of lateral femoral cutaneous nerve single shot and femoral nerve single shot block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.

Detailed Description
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Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.

Conditions
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-Postoperative Pain

Intervention / Treatment
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* Procedure: LFCNB
* Procedure: FNB
* Procedure: LFCNB
* Procedure: FNB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary hip arthroplasty with posterolateral approach. Exclusion Criteria: Known allergy to levobupivacaine and / or piritramide Known neurological disorders or peripheral neuropathies Existing drug or alcohol abuse Chronic use of pain medication (> started 3 months ago) not related to the hip suffering Coagulopathy (international normalized ratio) > 1.4 Thrombocytopenia <70,000 platelets, Dementia Pregnancy Local infection hip Hepatic and / or renal impairment BMI> 45.

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Group 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%. | Procedure: LFCNB<br>* LFCNB - Normal Saline solution 10 cc<br>Procedure: FNB<br>* FNB - Normal saline solution 10 cc<br>|
| Active Comparator: Group 2<br>Group 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%. | Procedure: LFCNB<br>* LFCNB - Normal Saline solution 10 cc<br>Procedure: FNB<br>* FNB - Chirocaine 0.25%, 20 cc<br>|
| Active Comparator: Group 3<br>Group 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution. | Procedure: LFCNB<br>* LFCNB - Chirocaine 0.25%, 20 cc<br>Procedure: FNB<br>* FNB - Chirocaine 0.25%, 20 cc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of opioids | The primary outcome measure will be a consumption of opioids through the Intravenous Patient Controlled Analgesia pump. Those amounts will be measured en documented at the fixed intervals during the first 48 hours post-procedure. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) scores (0-10) | The secondary outcome measure will be pain scores (VAS 0-10). Those scores will be measured en documented at the fixed intervals during the first 48 hours post-procedure. | 48 hours |