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

NCT04219098 | Completed

• 1 other identifier: Designer [1544619
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement; Arthroplasty

Keywords

THA; THR

Outcome Measures

Primary Outcomes (1)

• Accuracy

  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)

  Surgery

Secondary Outcomes (1)

• Blood Loss

  Postoperative day 1

Study Arms (2)

Treatment

EXPERIMENTAL

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

Procedure: Butterfly IQ

Control

ACTIVE COMPARATOR

Entire injection will be given after initial incision is made.

Other: Standard of Care

Interventions

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.

Treatment

Standard of Care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anne Arundel Health System Research Institute: lead

Study Sites (1)

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Only the surgeon and PA will be aware of the randomization assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Joint Replacement

Model Details: This study is designed to be prospective randomized (1:1) controlled independent trial.

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 6, 2020
• Study Start: February 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)