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

NCT ID: NCT02209272

Last Updated: 2019-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-02-28

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.

Conditions

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Hip Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bacteriostatic saline

for ultrasound guided hip joint injection local anesthesia

Group Type EXPERIMENTAL

bacteriostatic saline

Intervention Type DRUG

buffered lidocaine

for ultrasound guided hip joint injection local anesthesia

Group Type ACTIVE_COMPARATOR

buffered lidocaine

Intervention Type DRUG

Interventions

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bacteriostatic saline

Intervention Type DRUG

buffered lidocaine

Intervention Type DRUG

Other Intervention Names

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0.9% benzyl alcohol 1% lidocaine combined (9:1) with sodium bicarbonate

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jacob L. Sellon, M.D.

Assistant Professor of Physical Medicine and Rehabilitation, Sports Medicine Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacob Sellon, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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14-002622

Identifier Type: -

Identifier Source: org_study_id

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