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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bacteriostatic saline | Experimental | for ultrasound guided hip joint injection local anesthesia |
|
| buffered lidocaine | Active Comparator | for ultrasound guided hip joint injection local anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bacteriostatic saline | Drug |
|
| |
| buffered lidocaine |
| 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 |
| 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 |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Sellon, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bacteriostatic Saline | In this arm patients received 2 injections:
VAS-pain scores were collected immediately after each injection. |
| FG001 | Buffered Lidocaine | In this arm patients received 2 injections:
VAS-pain scores were collected immediately after each injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bacteriostatic Saline | In this arm patients received 2 injections:
VAS-pain scores were collected immediately after each injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | baseline to 5-10 minutes later -- immediately after local anesthetic injection administration |
|
The study treatment follow-up period is defined as two weeks post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bacteriostatic Saline | for ultrasound guided hip joint injection local anesthesia bacteriostatic saline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob L. Sellon | Mayo Clinic | 507-284-2608 | sellon.jacob@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2014 | Mar 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019905 | Benzyl Alcohol |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001592 | Benzyl Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001593 | Benzyl Compounds |
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| Drug |
|
|
| Anesthetic Infiltration Duration | Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds. | baseline |
| BG001 | Buffered Lidocaine | In this arm patients received 2 injections:
VAS-pain scores were collected immediately after each injection. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | seconds | baseline |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Buffered Lidocaine | for ultrasound guided hip joint injection local anesthesia buffered lidocaine | 0 | 36 | 0 | 36 | 0 | 36 |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |