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

Phase 4

Completed

• Conditions: Hip Pain
• Interventions: Drug: buffered lidocaine; Drug: bacteriostatic saline

• Registration Number: NCT02209272
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study First Submitted: 2014-07-31
• Study Start: 2014-08
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Results First Submitted: 2019-03-04
• Results First Submitted QC: 2019-03-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Results First Posted: 2019-04-02
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
buffered lidocaine	buffered lidocaine	for ultrasound guided hip joint injection local anesthesia
bacteriostatic saline	bacteriostatic saline	for ultrasound guided hip joint injection local anesthesia

Primary Outcome Measures

Name	Time	Method
VAS for Pain Score During Local Anesthesia Infiltration	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 Outcome Measures

Name	Time	Method
VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)	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	baseline	Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States