Skip to main content
OpenTrials
Completed

NCT Number: NCT04219098

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Hip Replacement Arthroplasty

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Butterfly IQ

Procedure

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.

Standard of care

Other

The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure.

Primary outcomes

  1. Accuracy

    Time frame: 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 outcomes

  1. Blood Loss

    Time frame: Postoperative day 1

    Evaluate blood loss as determined by relative change in HCT preoperatively and on the first post-operative day.

Sponsors and collaborators

Lead sponsor

Anne Arundel Health System Research Institute

Other

Registry information

Acronym: PUSH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2020
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.