Ultrasound Guided Fascia Iliaca Block for Pain Control After Elective Hip Replacement Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks performed before surgery help to reduce pain after elective total hip replacements.

Detailed Description
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Total hip arthroplasty is associated with moderate to severe pain in the acute postoperative period, which can increase the risk of postoperative complications such as thromboembolism, myocardial ischemia/infarction, pneumonia, poor wound healing, insomnia, and delirium. Sensory innervation of the hip joint comes from a combination of peripheral nerves, including femoral, obturator, sciatic, superior gluteal, and nerve for the quadratus femoris muscle. Superficial innervation of the skin involved in incision for hip arthroplasty comes from the lateral femoral cutaneous nerve (LFCN). The fascia iliaca block (FIB) was originally described in 1989 using a landmark technique. The ultrasound guided FIB was introduced in recent years, and has been shown to produce a better quality of block than the landmark technique. It appears to consistently block the femoral and LFCN, while being less successful in achieving consistent obturator blockade. The FIB is effective for analgesia for hip fracture injuries in the emergency department. Thus far, there has been limited exploration into the potential use of this block as a tool for postoperative analgesia after elective hip arthroplasty. The potential benefits of this regional block, as with other regional techniques, include better analgesia, less opioid use and associated side effects, and an improved overall patient satisfaction with postoperative recovery.

Official Title
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Ultrasound Guided Fascia Iliaca Block for Postoperative Analgesia After Elective Total Hip Arthroplasty

Conditions
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Arthroplasty, Replacement, Hip, Fascia Iliaca Block

Intervention / Treatment
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* Drug: .2% Ropivacaine
* Drug: Saline
* Procedure: Fascia Iliaca Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists' (ASA) score I, II or III Scheduled for elective total hip arthroplasty Exclusion Criteria: Contraindication to regional anesthesia (allergy to local anesthetic, coagulopathy, infection or malignancy in the area) Neurologic disorder affecting the ability to sense pain Long term opioid use or chronic pain disorder History of drug or alcohol abuse Patient refusal Pregnancy Revision procedures General anesthetic Psychiatric or mental conditions that may affect assessment of outcomes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fascia Iliaca Block - Ropivacaine<br>Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of 0.2% ropivacaine. | Drug: .2% Ropivacaine<br> <br> Procedure: Fascia Iliaca Block<br>* Ultrasound-guided regional anesthesia block to the groin area.<br>|
| Sham Comparator: Fascia Iliaca Block - Saline<br>Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of Saline. | Drug: Saline<br> <br> Procedure: Fascia Iliaca Block<br>* Ultrasound-guided regional anesthesia block to the groin area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative opioid consumption | Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison | 12 hours after surgery | 
| Cumulative opioid consumption | Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative opioid consumption | Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison | 4, 8, and 48 hours after surgery | 
| Verbal pain score (static and dynamic) | Pain score 0-10 with 10 being worst possible pain | PACU, 4, 8, 12, 24, and 48 hours after surgery | 
| Opioid side effect (nausea/vomiting, pruritus, constipation, urinary retention, sedation) | Presence of each side effect documented as yes or no. Sedation will be assessed by the Ramsay Sedation Scale. | PACU, 4, 8, 12, 24, and 48 hours after surgery | 
| Overall patient satisfaction | Satisfaction rated as: very dissatisfied, dissatisfied, neutral, satisfied, or very satisfied | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Hip, Pain, Postoperative, Nerve Block, Anesthesia, Regional, Fascia Iliaca Block, Ultrasound Guided