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The duration of the autonomic (sympathetic) block will last longer than the sensory block. The duration of the increased perfusion index will last longer than either the sympathetic or sensory block.
The Masimo SpHb™ (SpHb) is a device used to monitor the blood hemoglobin level via a sticky sensor connected to a finger. Our results from 2 recent studies undertaken with this device concluded: 1) that it is not always accurate when the finger is cold such as during surgical blood loss, and 2) a local nerve block to the finger improved the finger temperature and the accuracy of the device.
Our purpose is to investigate the duration of effect of two local nerve blocking drugs (lidocaine and bupivacaine - both FDA approved drugs in routine use) in a finger on each hand. Having a better understanding of how long the nerve block lasts could help determine when an additional block might be necessary to maintain the accuracy of the device during surgical blood loss.
We previously listed the primary outcome for this study as the time until return to baseline finger temperature. However, in blinded looks at the data it became clear that defining time until return to baseline from the serial temperature measurements in an objective fashion would be extremely difficult and potentially controversial. We have modified the primary outcome to be the change in the average temperature from baseline to post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | Lidocaine 1% Digital Nerve Block (2 cc) |
|
| Bupivacaine | Active Comparator | Bupivacaine 0.25% Digital Block (2 cc) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Digital Nerve Block | Drug | Lidocaine 1% Digital Nerve Block (2 cc |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in the Average Finger Temperature From Baseline to Post-intervention. | 30 minutes prior and 240 minutes post intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Miller, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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Volunteers recruited through local media source. Protocol consisted of a single study day in anesthesia research study space at the University of California San Francisco Parnassus campus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger | Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger. |
| FG001 | Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bupivacaine Digital Block |
| Drug |
Bupivacaine 0.25% Digital Block (2 cc) |
|
Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger | Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger |
| BG001 | Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger | Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | The Change in the Average Finger Temperature From Baseline to Post-intervention. | The correspondingly-treated(lidocaine, bupivacaine) finger of all 12 study participants included in analysis for each arm/group | Posted | Mean | Standard Error | degrees centigrade | 30 minutes prior and 240 minutes post intervention. |
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1 day
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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 | Lidocaine digital block in right or left finger | 0 | 12 | 1 | 12 | ||
| EG001 | Bupivacaine | Bupivacaine digital block right or left finger | 0 | 12 | 1 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment | 2-3 millimeter raised, reddened blister-like area at the base of both the right and left 4th finger of the same participant. No drainage, pain or irritation noted. Participant was contacted to verify resolution at 7 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald D Miller, MD | University of California San Francisco | 415 476-9034 | millerr@anesthesia.ucsf.edu |
| >=65 years |
|
| Male |
|