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

• Sponsor: Anne Arundel Health System Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04219098
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.9
• Patients Per Site Per Month: 21.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Replacement; Arthroplasty	Procedure: Butterfly IQ; Other: Standard of Care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study is designed to be prospective randomized (1:1) controlled independent trial.This study is designed to be prospective randomized (1:1) controlled independent trial.
• Masking: Double (Care Provider, Investigator)
• Masking Description: Only the surgeon and PA will be aware of the randomization assignment
• Primary Purpose: Treatment
• Official Title: Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)
• Anticipated Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Jul 30, 2020
• Anticipated Study Completion Date: Aug 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Butterfly IQ utilized to inject 10cc prior to surgery the remainder after incision	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.
Active Comparator: Control Entire injection will be given after initial incision is made.	Other: Standard of Care; The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure.

Outcome Measures

Primary Outcome Measures

1. 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 PROMIS pain score

Secondary Outcome Measures

1. Blood Loss [Postoperative day 1]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anne Arundel Medical Center	Annapolis	Maryland	United States	21401

Sponsors and Collaborators

• Anne Arundel Health System Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul King, Director of the Center for Joint Replacement, Anne Arundel Health System Research Institute
• ClinicalTrials.gov Identifier: NCT04219098
• Other Study ID Numbers: Designer [1544619
• First Posted: Jan 6, 2020
• Last Update Posted: Jan 6, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Paul King, Director of the Center for Joint Replacement, Anne Arundel Health System Research Institute: THA; THR

Study Results

No Results Posted as of Jan 6, 2020