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Completed

NCT Number: NCT02209272

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bacteriostatic saline

Drug

Other names: 0.9% benzyl alcohol

Buffered Lidocaine

Drug

Other names: 1% lidocaine combined (9:1) with sodium bicarbonate

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2014
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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