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

NCT ID: NCT04219098

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-08-30

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

Conditions

Total Hip Replacement; Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Butterfly IQ utilized to inject 10cc prior to surgery the remainder after incision

Group Type: EXPERIMENTAL

Butterfly IQ

Intervention Type: 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.

Control

Entire injection will be given after initial incision is made.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: PROCEDURE

Standard of Care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anne Arundel Health System Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Paul King

Director of the Center for Joint Replacement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anne Arundel Medical Center

Annapolis, Maryland, United States

Countries

United States

Other Identifiers

Designer [1544619

Identifier Type: -

Identifier Source: org_study_id