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Clinical Trials/NCT02209272
NCT02209272
Completed
Phase 4

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

Mayo Clinic1 site in 1 country68 target enrollmentAugust 2014

Overview

Phase
Phase 4
Intervention
bacteriostatic saline
Conditions
Hip Pain
Sponsor
Mayo Clinic
Enrollment
68
Locations
1
Primary Endpoint
VAS for Pain Score During Local Anesthesia Infiltration
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
February 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jacob L. Sellon, M.D.

Assistant Professor of Physical Medicine and Rehabilitation, Sports Medicine Center

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

bacteriostatic saline

for ultrasound guided hip joint injection local anesthesia

Intervention: bacteriostatic saline

buffered lidocaine

for ultrasound guided hip joint injection local anesthesia

Intervention: buffered lidocaine

Outcomes

Primary Outcomes

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

  • VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)(baseline to 5-10 minutes later -- immediately after hip joint injection)
  • Anesthetic Infiltration Duration(baseline)

Study Sites (1)

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