Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty

Study Overview
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Brief Summary
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This study evaluates post-operative pain management and narcotic consumption in patients receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca block with saline for total hip arthroplasty.

Detailed Description
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Although many improvements have been made in implant technology and surgical approaches for total hip arthroplasty, management of post-operative pain remains a major clinical issue. Inadequate pain control can lead to numerous unwanted side effects and limited physical function, especially in a older population. Most surgeons have adopted a multi-modality pain management approach using a variety of pharmaceuticals, including nerve block with local anesthetic. In the literature, there are a number of technical variations described for the fascia iliaca nerve block. At The Christ Hospital, Cincinnati, Ohio, anesthesiologists use a more proximal approach to the fasica iliaca block enabling a significantly easier cephalad spread of the local anesthetic into the pelvis targeting all three nerves; the femoral, lateral femoral cutaneous, and the obturator. This prospective, double-blinded, randomized, single-center study is designed to test the primary hypothesis that fascia iliaca block with a local anesthestic decreases narcotic consumption and provides improved pain control compared to placebo in the first 24 hours after surgery in patients undergoing total hip arthroplasty.

Official Title
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Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Conditions
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Osteoarthritis of the Hip

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: anterior approach total hip arthroplasty (THA) for unilateral osteoarthritis English-speaking age 18 to 75 years American Society of Anesthesiologists (ASA) physical status 1 to 3 BMI < 40 kg/m2 Minimum weight of 50 kg. No contraindications to study procedures Exclusion Criteria: Hip revision surgery Allergy to local anesthetics Allergy to oxycontin Allergy to pregabalin Allergy to fentanyl Allergy to midazolam Allergy to hydromorphone BMI > 40 kg/m2 Chronic pre-operative opioid use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: ropivacaine block<br>Ropivacaine 0.375% as a one-time 60 milliliter injection. | Drug: Ropivacaine<br>* 0.375% ropivacaine as a one-time, 60 milliliter injection<br>* Other names: Naropin;|
| Placebo Comparator: saline block<br>Sodium chloride 0.9% as a one-time 60 milliliter injection. | Drug: Saline<br>* Saline as a one-time, 60 milliliter injection.<br>* Other names: Sodium Chloride 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Control | Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor. | 24 hours | 
| Opioid Consumption | Measured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Operative Care Unit (PACU) Length of Stay | Length of PACU stay is measured from arrival in PACU to clinical discharge from PACU | From 60 minutes to 6 hours |