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

NCT05209399 | Completed

• 1 other identifier: STUDY00006887
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hip injection with prior local anesthesia

ACTIVE COMPARATOR

Procedure: Ultrasound guided injection

Hip injection without prior local anesthesia

ACTIVE COMPARATOR

Procedure: Ultrasound guided injection

Interventions

Ultrasound guided injection PROCEDURE

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.

Hip injection with prior local anesthesia; Hip injection without prior local anesthesia

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• American Medical Society for Sports Medicine: collaborator

Study Sites (1)

University of Rochester Medical Center Physical Medicine and Rehabilitation

Rochester, New York, 14618, United States

Location

Related Publications (1)

• Lazaro RM, Smith JM, Bender N, Punreddy A, Barford N, Paul JH. Comparison of Pain With Ultrasound-Guided Intra-Articular Hip Injections With and Without Prior Subcutaneous Local Anesthesia. Clin J Sport Med. 2024 Jul 24;35(5):543-548. doi: 10.1097/JSM.0000000000001260.

  PMID: 39046314 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: June 30, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)