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Departure of principal investigator
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This is a dose finding study to identify the minimum effective anesthetic concentration (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane (TAP) blocks in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Experimental | Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine concentration | Drug | Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population | The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Complications | All patients were followed up for complications such as bleeding, infection, side effects, nerve damage | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Lam, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Mexico Outpatient Surgical and imaging service | Albuquerque | New Mexico | 87102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine | Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine | Each patient received ropivacaine-based nerve blockade at a fixed volume, with concentration determined per protocol |
| 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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| Gender | Count of Participants | 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 | Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population | The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol. | Posted | Number | percentage concentration, ropivacaine | 1 day |
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| Secondary | Number of Patients With Complications | All patients were followed up for complications such as bleeding, infection, side effects, nerve damage | Posted | Count of Participants | Participants | 3 days |
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3 days
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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 | Ropivacaine | Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block | 0 | 49 | 11 | 49 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failure of regional anesthesia | Surgical and medical procedures | Non-systematic Assessment | As this was a dose-finding study, it was expected that some patients would experience failure of regional anesthesia. |
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Early termination leading to small numbers of subjects analyzed. Confidence intervals for primary outcome are not reliable and therefore not reported.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tim Petersen | UNM Department of Anesthesiology | 5052722610 | 505 | timpetersen@salud.unm.edu |
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