Clinical trial NCT04219098: Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)
Official title: Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Arthroplasty
Keywords: THA
THR
Lead sponsor: Anne Arundel Health System Research Institute
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed to be prospective randomized (1:1) controlled independent trial.
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: Inclusion Criteria

Subjects meeting all of the following specific criteria will be considered for participation in the study:

1. Subject is between 18-80 years of age.
2. Subject is a suitable candidate for total hip replacement.
3. Subject scheduled for surgery with the Butterfly IQ trained PA providing surgical assistance
4. 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
5. 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.
6. 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:

1. Subject is a woman who is pregnant or lactating
2. Subject from the vulnerable groups: prisoners, adults unable to consent, children, non-English speaking, illiterate, and/or visually impaired)
3. Subject who is not comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.
4. Subject who cannot or refuses to give voluntary, written informed consent to participate in this clinical trial
5. Subject has contraindications for any of the following: Ropivicaine, Epinephrine or Methylene Blue
6. Previous hip surgery
7. History of infection in hip
8. Morbid obesity defined as BMI\>40

Primary outcomes:
measure: Accuracy
timeFrame: Surgery
Secondary outcomes:
measure: Blood Loss
timeFrame: Postoperative day 1
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
Study officials:
References: