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Study halted due to COVID-19 pandemic and terminated early per request of principal investigator as Chloroprocaine use in spinal procedures has become incorporated as standard of care at HSS.
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Outpatient knee surgeries with duration of less than one hour pose a challenge to the use of spinal anesthesia given that traditional agents remain in effect for 2-3 hours, thus creating a mismatch between length of surgery and anesthetic resolution. The investigators hypothesize that the use of chloroprocaine can combine the benefits of a short spinal anesthetic while avoiding the side effects of a general anesthetic, thus promoting earlier discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloroprocaine | Experimental |
| |
| Mepivacaine | Active Comparator |
| |
| General Anesthesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroprocaine | Drug | A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Readiness for Discharge | Defined as duration from arrival in the post-anesthesia care unit (PACU0 to the time patient meets the discharge criteria from the post anesthesia discharge scoring system (PADSS) for home readiness after ambulatory surgery | Determine within 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kim | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chloroprocaine | Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed |
| FG001 | Mepivacaine | Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed |
| FG002 | General Anesthesia | General Anesthetics: General anesthetics will be administered intravenously |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chloroprocaine | Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed |
| BG001 | Mepivacaine | Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed |
| 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 | Readiness for Discharge | Defined as duration from arrival in the post-anesthesia care unit (PACU0 to the time patient meets the discharge criteria from the post anesthesia discharge scoring system (PADSS) for home readiness after ambulatory surgery | Posted | Mean | Standard Deviation | minutes | Determine within 24 hours after surgery |
|
Safety surveillance and reporting starts as soon as the subject undergoes surgery and receives treatment and lasts until the subject concludes their participation in the study or the subject/investigator withdraws the subject from the study. Up to 7 days following surgery.
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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 | Chloroprocaine | Chloroprocaine: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed |
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This project was terminated early, as enrollment was negatively impacted to due to the COVID-19 pandemic and because clinical practice has shifted to include the use of chloroprocaine in spinal procedures as standard of care at the Hospital for Special Surgery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marla Sharp, MPH, MA | Hospital for Special Surgery | 646-797-8419 | sharpm@hss.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 | Feb 4, 2021 | May 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C004616 | chloroprocaine |
| D008619 | Mepivacaine |
| D018681 | Anesthetics, General |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000777 | Anesthetics |
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| Mepivacaine | Drug | A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed |
|
| General Anesthetics | Drug | General anesthetics will be administered intravenously |
|
| BG002 | General Anesthesia | General Anesthetics: General anesthetics will be administered intravenously |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| ASA Physical Status Classification | Count of Participants | Participants |
|
| General Anesthesia |
General Anesthetics: General anesthetics will be administered intravenously |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Mepivacaine | Mepivacaine: A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | General Anesthesia | General Anesthetics: General anesthetics will be administered intravenously | 0 | 13 | 0 | 13 | 0 | 13 |
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| D002492 |
| Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |