Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)

Study Overview
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Brief Summary
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The purpose of the study is to assess the accuracy of Butterfly IQ ultrasound for intra-articular hip injections, and to see if an injection given intra-articular before incision provides any benefit in preemptive pain relief or blood loss reduction.

Detailed Description
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This study is designed to be prospective randomized (1:1) controlled independent trial. Subjects are male and female, aged 18 and above, who are suitable candidates for either a unilateral (i.e. single) total hip replacement. Subjects that are scheduled with a single, extensively trained Physician Assistant assisting in their surgery will be exclusively included. This is single site study with projected enrollment of 150 subjects

Official Title
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Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)

Conditions
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Total Hip Replacement, Arthroplasty

Intervention / Treatment
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* Procedure: Butterfly IQ
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects meeting all of the following specific criteria will be considered for participation in the study: Subject is between 18-80 years of age. Subject is a suitable candidate for total hip replacement. Subject scheduled for surgery with the Butterfly IQ trained PA providing surgical assistance Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to AAHS RI Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures. Subject must be comfortable with speaking, reading, and understanding questions in English and providing an appropriate response. Exclusion Criteria Subjects will be excluded from participation in the study if they meet any of the following criteria: Subject is a woman who is pregnant or lactating Subject from the vulnerable groups: prisoners, adults unable to consent, children, non-English speaking, illiterate, and/or visually impaired) Subject who is not comfortable with speaking, reading, and understanding questions in English and providing an appropriate response. Subject who cannot or refuses to give voluntary, written informed consent to participate in this clinical trial Subject has contraindications for any of the following: Ropivicaine, Epinephrine or Methylene Blue Previous hip surgery History of infection in hip Morbid obesity defined as BMI>40

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: Parallel Assignment
Interventional Model Description: This study is designed to be prospective randomized (1:1) controlled independent trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Butterfly IQ utilized to inject 10cc prior to surgery the remainder after incision | Procedure: Butterfly IQ<br>* 10ml of solution with .5cc (or one drop) sterile methylene blue will be injected intra-articularly under ultrasound guidance after a sterile prep. The remaining 20ml will be injected into the periarticular tissues after prosthesis implantation before closure.<br>|
| Active Comparator: Control<br>Entire injection will be given after initial incision is made. | Other: Standard of Care<br>* The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | Primary objective is to determine the accuracy of the Butterfly IQ portable app based ultrasound device used in intra-articular hip injections determined by patient reported pain ratings using the PROMIS pain score | Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss | Evaluate blood loss as determined by relative change in HCT preoperatively and on the first post-operative day. | Postoperative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THA, THR