Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection technique (also called a nerve block) that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. The SIFI technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This block may affect movement in the leg and make the legs weak. The amount of leg weakness is not known and assessment of this will be included in the study. Many institutions use the SIFI block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.

Official Title
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Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty

Conditions
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Pain, Hip Osteoarthritis, Primary Total Hip Arthroplasty

Intervention / Treatment
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* Procedure: Suprainguinal fascia iliaca (SIFI) block
* Procedure: Sham block
* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking between 18 and 75 years old American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty Exclusion Criteria: ASA 4 or 5 revision hip arthroplasty diagnosis of chronic pain daily chronic opioid use (over 3 months of continuous opioid use) inability to communicate pain scores or need for analgesia acute hip fracture Infection at the site of block placement Age under 18 years old or greater than 75 years old Pregnant women Intolerance/allergy to local anesthetics Weight <50 kg Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprainguinal Fascia Iliaca (SIFI) block<br>A nerve block technique using a numbing medication called ropivacaine. | Procedure: Suprainguinal fascia iliaca (SIFI) block<br>* An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.<br>Drug: Ropivacaine<br>* Local anesthetic (numbing drug)<br>* Other names: Naropin;|
| Placebo Comparator: Sham group<br>The same nerve block technique as above, however using an inactive solution of salt water. | Procedure: Sham block<br>* An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.<br>Drug: Saline<br>* Salt water placebo<br>* Other names: Salt water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11 | The NRS 11 ranges from 0 (no pain) to 10 (intense pain). | 4 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Opioid Consumption | Reported in IV morphine equivalents. | 24 hours | 
| Motor Strength, as Measured by Dynamometry | Reported as pounds per square inch (PSI). | 4 hours postoperatively | 
| Numeric Pain Score at 24 Hours, as Measured by NRS 11 | The NRS 11 ranges from 0 (no pain) to 10 (intense pain). | 24 hours | 
| Ambulation, as Measured by Distanced Walked |  | post-op day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suprainguinal fascia iliaca (SIFI), nerve block