Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia

Overview

The purpose of this study is to compare infiltration pain and anesthetic efficacy between lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip injections.

Full Title of Study: “Local Anesthesia for Ultrasound Guided Hip Joint Injections: A Double-Blinded Randomized Controlled Trial of Bacteriostatic Saline Versus Buffered Lidocaine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2018

Detailed Description

Local anesthesia is commonly used to reduce pain during joint injections, particularly for deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most medical practices. It is well known that lidocaine infiltration itself is painful. Many strategies have been studied to minimize pain associated with lidocaine administration, including buffering, warming, and slowing infiltration rate. BS is an alternative local anesthetic that has been shown to be less painful when injected into subcutaneous tissues compared with lidocaine. However, BS use has not been widely implemented for local anesthesia, and it has not been studied in the context of joint injections.

Interventions

  • Drug: bacteriostatic saline
  • Drug: buffered lidocaine

Arms, Groups and Cohorts

  • Experimental: bacteriostatic saline
    • for ultrasound guided hip joint injection local anesthesia
  • Active Comparator: buffered lidocaine
    • for ultrasound guided hip joint injection local anesthesia

Clinical Trial Outcome Measures

Primary Measures

  • VAS for Pain Score During Local Anesthesia Infiltration
    • Time Frame: baseline to 5-10 minutes later — immediately after local anesthetic injection administration
    • The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by “no pain” (score of 0) and “pain as bad as it could be” (score of 100).

Secondary Measures

  • VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)
    • Time Frame: baseline to 5-10 minutes later — immediately after hip joint injection
    • The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by “no pain” (score of 0) and “pain as bad as it could be” (score of 100).
  • Anesthetic Infiltration Duration
    • Time Frame: baseline
    • Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.

Participating in This Clinical Trial

Inclusion Criteria

  • age 18-75 years – referred for US-guided intraarticular hip injections in the Mayo Clinic Sports Medicine Center, Physical Medicine & Rehabilitation Clinic, or Musculoskeletal Clinic EXCLUSION CRITERIA:

  • chronic opioid use – opioid use on day of procedure – history of fibromyalgia or other diffuse chronic pain syndrome – pain behavior during the clinical encounter as judged by the injectionist – anesthetic administration time outside the designated 5-15 second time frame

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jacob L. Sellon, M.D., Assistant Professor of Physical Medicine and Rehabilitation, Sports Medicine Center – Mayo Clinic
  • Overall Official(s)
    • Jacob Sellon, MD, Principal Investigator, Mayo Clinic

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