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

Not Applicable

Completed

• Conditions: Total Hip Replacement; Arthroplasty
• Interventions: Other: Standard of Care; Procedure: Butterfly IQ

• Registration Number: NCT04219098
• Lead Sponsor: Anne Arundel Health System Research Institute

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

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Study Start: 2020-02-01
• Primary Completion: 2021-07-30
• Study Completion: 2021-08-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard of Care	Entire injection will be given after initial incision is made.
Treatment	Butterfly IQ	Butterfly IQ utilized to inject 10cc prior to surgery the remainder after incision

Primary Outcome Measures

Name	Time	Method
Accuracy	Surgery	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 Patient Reported Outcome Measure Information System (PROMIS) pain rating 0(no pain)- 5 (most pain)

Secondary Outcome Measures

Name	Time	Method
Blood Loss	Postoperative day 1	Evaluate blood loss as determined by relative change in HCT preoperatively and on the first post-operative day.

Trial Locations

Locations (1)

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States