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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.
Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Narcotic Use | Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day. | Surgery to post operative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale of Pain (0-10) | Visual Analog Scale (VAS) of pain (0-10); with 10 indicating the greatest amount of pain. Post anesthesia care unit admission, post anesthesia care unit discharge, day of surgery, post operative day 1, post operative day 2, post operative day 3 | Post anesthesia care unit admission to post operative day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M Odum, PhD | OrthoCarolina Research Institute | Study Director |
| Bruce Cohen, MD | OrthoCarolina Foot & Ankle Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina, PA | Charlotte | North Carolina | 28203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel | Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients completing study
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel | Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case. |
| 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 | Amount of Narcotic Use | Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day. | Posted | Mean | Full Range | mg | Surgery to post operative day 3 |
|
|
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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 | Overall | Data across all patients | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased pain | General disorders | Non-systematic Assessment | Increased pain caused admission to floor from PACU. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| superficial cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Developed a superficial cellulitis that required antibiotic treatment. There were no secondary surgical procedures necessary. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Odum | OrthoCarolina Research Institute | 7049457710 | susan.odum@orthocarolina.com |
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| Anti-emetic Use |
Anti-emetic use (as a binary yes/no) between the admission in the post anesthesia care unit through hospital discharge (i.e. if a patient took an anti-emetic at any point duration the time frame the patient was a yes; if the patient did not take an anti-emetic during the time frame the patient was a no). |
| After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3) |
| Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | Measured at hospital discharge (on post operative day 3). Measured on a scale of 1-5, with 5 being the most satisfaction | Measured at hospital discharge (on post operative day 3) |
| Number of Patients With Post-operative Complications | Any complications occurring between the day of surgery and the first scheduled appointment at our clinic after the surgery. | After surgery to the first scheduled clinic visit, usually 14 days after surgery |
| 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 | Number | participants |
|
|
| Secondary | Visual Analog Scale of Pain (0-10) | Visual Analog Scale (VAS) of pain (0-10); with 10 indicating the greatest amount of pain. Post anesthesia care unit admission, post anesthesia care unit discharge, day of surgery, post operative day 1, post operative day 2, post operative day 3 | Posted | Mean | Full Range | units on a scale | Post anesthesia care unit admission to post operative day 3 |
|
|
|
| Secondary | Anti-emetic Use | Anti-emetic use (as a binary yes/no) between the admission in the post anesthesia care unit through hospital discharge (i.e. if a patient took an anti-emetic at any point duration the time frame the patient was a yes; if the patient did not take an anti-emetic during the time frame the patient was a no). | Posted | Count of Participants | Participants | After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3) |
|
|
|
| Secondary | Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | Measured at hospital discharge (on post operative day 3). Measured on a scale of 1-5, with 5 being the most satisfaction | Posted | Count of Participants | Participants | Measured at hospital discharge (on post operative day 3) |
|
|
|
| Secondary | Number of Patients With Post-operative Complications | Any complications occurring between the day of surgery and the first scheduled appointment at our clinic after the surgery. | Posted | Count of Participants | Participants | After surgery to the first scheduled clinic visit, usually 14 days after surgery |
|
|
|
| 36 |
| 1 |
| 36 |
| 1 |
| 36 |
|
|
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| Post-Operative Day 1 |
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| Post-operative Day 2 |
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| Post-operative Day 3 |
|
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| 5 |
|