Comparison of Ultrasound-guided Intraarticular Hip Injections With and Without Prior Local Anesthesia

Comparison of Ultrasound-guided Intraarticular Hip Injections With and Without Prior Local Anesthesia: a Randomized Controlled Trial

In this single-center randomized controlled trial, subjects undergoing a first-time ultrasound-guided unilateral intraarticular hip injection will be randomized into one of two groups: hip injection with prior local anesthesia (With LA) or hip injection without prior local anesthesia (Without LA). Visual analog scale (VAS) pain scores (0-100) will be collected after the local anesthesia injection (With LA group) and intraarticular hip injection (both groups). The primary outcome measure for comparison between the two groups will be VAS score for the intraarticular hip injection.

Study Overview

• Status: Completed
• Conditions: Hip Pain
• Intervention / Treatment: Procedure: Ultrasound guided injection

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14618
      • University of Rochester Medical Center Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients undergoing a first-time ultrasound-guided unilateral intraarticular hip injection
• Subjects must be fluent in English
• Subject must be able to consent for themselves and mark pain levels on a visual analog scale.

Exclusion Criteria:

• previous intraarticular hip injection (to remove bias from prior injection experiences)
• prior surgery on the hip to be injected
• use of opioid medication on the day of or day before the procedure
• diabetes mellitus
• body mass index (BMI) greater than 40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hip injection with prior local anesthesia	Procedure: Ultrasound guided injection; All intraarticular hip injections will be performed under real-time ultrasound guidance using a GE LOGIQ P9 ultrasound machine with a C1-5-RS 1-5 MHz curvilinear transducer (GE Healthcare, Chicago, IL, USA). For the procedure, patients will be placed in a supine position. The curvilinear transducer and ultrasound machine will be used to visualize the anterior aspect of the hip joint in a sagittal oblique plane. Sterile technique will be used to perform the procedure.
Active Comparator: Hip injection without prior local anesthesia	Procedure: Ultrasound guided injection; All intraarticular hip injections will be performed under real-time ultrasound guidance using a GE LOGIQ P9 ultrasound machine with a C1-5-RS 1-5 MHz curvilinear transducer (GE Healthcare, Chicago, IL, USA). For the procedure, patients will be placed in a supine position. The curvilinear transducer and ultrasound machine will be used to visualize the anterior aspect of the hip joint in a sagittal oblique plane. Sterile technique will be used to perform the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean pain score	A visual analog pain score will be collected. The scale of the score is 0-100 with 100 indicating more pain.	baseline

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: American Medical Society for Sports Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00006887

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No