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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hip Pain

Intervention / Treatment
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* Drug: bacteriostatic saline
* Drug: buffered lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bacteriostatic saline<br>for ultrasound guided hip joint injection local anesthesia | Drug: bacteriostatic saline<br> <br> * Other names: 0.9% benzyl alcohol;|
| Active Comparator: buffered lidocaine<br>for ultrasound guided hip joint injection local anesthesia | Drug: buffered lidocaine<br> <br> * Other names: 1% lidocaine combined (9:1) with sodium bicarbonate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for Pain Score During Local Anesthesia Infiltration | 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). | baseline to 5-10 minutes later -- immediately after local anesthetic injection administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy) | 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). | baseline to 5-10 minutes later -- immediately after hip joint injection | 
| Anesthetic Infiltration Duration | Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds. | baseline |