Fascia Iliaca Blocks for Total Hip Arthroplasty

Study Overview
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Brief Summary
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The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Although this technique requires a smaller incision than other approaches used for hip surgery, adequate postoperative pain management remains crucial for enhanced recovery and early rehabilitation. The fascia iliaca block (FIB) is commonly used to enhance analgesia after hip replacement surgery, however the effect of FIB volume on analgesia quality and sensory-motor blockade have not been adequately studied. In this study, total postsurgical opioid consumption (morphine equivalents IV in hospital and oral at home) through the first postoperative week will be compared and extent and duration of sensory motor block through the 2-day inpatient stay will be evaluated.

Official Title
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Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty

Conditions
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THA

Intervention / Treatment
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* Drug: Marcaine 0.25 % Injectable Solution
* Drug: Marcaine 0.25 % Injectable Solution
* Drug: Sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, at least 18 years of age at screening Scheduled for unilateral DAA THA American Society of Anesthesiologists (ASA) physical status 1, 2 or 3 Able to demonstrate sensory function by exhibiting sensitivity to light touch, pinprick and cold Able to ambulate Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments Exclusion Criteria: Previous open hip surgery History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics Contraindication to bupivacaine or morphine Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to the hip surgery and which may confound the postsurgical assessments Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®) Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2 Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Low dosis bupivacaine<br>Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height) | Drug: Marcaine 0.25 % Injectable Solution<br>* Fascia iliaca block with volume 0.11 mL x subject height<br>|
| Active Comparator: High dosis bupivacaine<br>Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height) | Drug: Marcaine 0.25 % Injectable Solution<br>* Fascia iliaca block with volume 0.22 mL x subject height<br>|
| Placebo Comparator: Placebo<br>Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height) | Drug: Sodium chloride<br>* Fascia iliaca block with volume 0.11 mL x subject height<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with movement | Day 0 | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | PACU arrival | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | PACU discharge | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 6 hours | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 12 hours | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 24 hours | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 36 hours | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | 48 hours | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 2 evening | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 3 morning | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 3 evening | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 4 | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 5 | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 6 | 
| Current pain assessed by numeric rating scale (NRS) | Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | PACU arrival | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | PACU discharge | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 6 hours | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 12 hours | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 24 hours | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 36 hours | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | 48 hours | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 2 evening | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 3 morning | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 3 evening | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 4 | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 5 | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 6 | 
| Total opioid consumption | Amount of opioid medication taken (IVPCA or oral) | Day 7 | 
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | Day 0 | 
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | Post block | 
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | PACU arrival | 
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | PACU discharge | 
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | 6 hours | 
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | 12 hours | 
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | 36 hours | 
| Sensory-motor blockade onset and duration | Cold, pinprick, light touch in affected dermatomes + strength and angle of knee | 48 hours |