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

Hip Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209272
• Other study ID #: 14-002622
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: February 2018

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Pain

Intervention

Drug:
• bacteriostatic saline

• buffered lidocaine

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Anesthetic Infiltration Duration	Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.	baseline

External Links

•   Mayo Clinic Clinical Trials