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The objective of our study is to determine if technique of lidocaine administration can decrease pain perception.
Hypothesis: There will be a significant difference in pain perception between patients who are given lidocaine on the skin surface prior to subcutaneous injection and patients who are given only subcutaneous injection by standard approach.
This is a single center prospective, randomized, blinded study assessing pain perception following 2 different lidocaine administration techniques in subjects who have planned medical procedures requiring local injection of lidocaine. Subjects will be approached and consented to participate in the study. They will be interviewed after the scheduled medical procedure to assess their pain using validated pain scores. An investigator who is not present for the procedure and blinded to the randomization will gather data regarding perceptions of pain from the entire procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine onto skin prior to lidocaine subcutaneous injection | Experimental | 1-2ml of 1% lidocaine dripped onto the surface of the skin immediately prior to subcutaneous injection of 1% lidocaine. |
|
| lidocaine subcutaneous injection alone | Active Comparator | 1% lidocaine subcutaneous injection alone by standard approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine | Drug | 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment: Overall | Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome. | post procedure (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment: Lidocaine Injection | visual analog scale (VAS) 0= no pain to 100 = worse pain possible | post procedure (day 1) |
| Pain Assessment: During Procedure | visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Kress, MD. | Univeristy of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29698720 | Derived | Patel BK, Wendlandt BN, Wolfe KS, Patel SB, Doman ER, Pohlman AS, Hall JB, Kress JP. Comparison of Two Lidocaine Administration Techniques on Perceived Pain From Bedside Procedures: A Randomized Clinical Trial. Chest. 2018 Oct;154(4):773-780. doi: 10.1016/j.chest.2018.04.018. Epub 2018 Apr 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection | lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection. |
| FG001 | Lidocaine Subcutaneous Injection Alone | lidocaine: 1% lidocaine subcutaneous injection alone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection | lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection. |
| BG001 | Lidocaine Subcutaneous Injection Alone |
| 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 | Pain Assessment: Overall | Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | post procedure (day 1) |
|
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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 | Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection | lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John P. Kress, MD | University of Chicago | 773-702-1000 | jkress@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| lidocaine | Drug | 1% lidocaine subcutaneous injection alone |
|
| post procedure (day 1) |
lidocaine: 1% lidocaine subcutaneous injection alone.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pain Assessment: Lidocaine Injection | visual analog scale (VAS) 0= no pain to 100 = worse pain possible | Posted | Mean | Standard Deviation | units on a scale | post procedure (day 1) |
|
|
|
| Secondary | Pain Assessment: During Procedure | visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection. | Posted | Mean | Standard Deviation | units on a scale | post procedure (day 1) |
|
|
|
| 0 |
| 244 |
| 0 |
| 244 |
| 0 |
| 244 |
| EG001 | Lidocaine Subcutaneous Injection Alone | lidocaine: 1% lidocaine subcutaneous injection alone | 0 | 237 | 0 | 237 | 0 | 237 |
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| Aniline Compounds |
| D000588 | Amines |