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

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Pain
• Intervention / Treatment: Drug: bacteriostatic saline; Drug: buffered lidocaine

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Benzyl Alcohol
• Other Study ID Numbers: 14-002622