NCT04219098

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Anne Arundel Health System Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Total Hip Replacement
• Arthroplasty

Interventions

Type	Name	Description
PROCEDURE	Butterfly IQ	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.
OTHER	Standard of Care	The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure.

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-07-30
• Completion: 2021-08-30
• First posted: 2020-01-06
• Last updated: 2024-08-07

Locations

1 site across 1 country: United States