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| ID | Type | Description | Link |
|---|---|---|---|
| BHS120036 | Other Identifier | Local IRB |
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A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic urologic surgeries in an effort to determine which method reduced postoperative opioid use the most.
Liposomal bupivacaine was developed to extend the duration of efficacy of bupivacaine from the typical 6 - 8 hours up to 72 hours. The prolonged duration of liposomal bupivacaine was initially demonstrated in mice in 1994. Two randomized controlled trials using liposomal bupivacaine for bunionectomy and hemorrhoidectomy resulted in FDA approval for its use in humans. More recently, liposomal bupivacaine has also been found to improve pain control for patients undergoing total knee arthroplasty. Infiltration of a local anesthetic into laparoscopic port sites is a common practice that has been shown in some studies to improve postoperative pain. To compare liposomal bupivacaine and 0.25% bupivacaine for local analgesia following laparoscopic and robotic urologic surgery, a randomized comparison-controlled trial was performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | Surgical site infiltration of 0.25% bupivacaine. |
|
| Liposomal bupivacaine | Experimental | Surgical site infiltration of liposomal bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug |
| ||
| liposomal bupivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay | Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Scores. | Visual analog pain scores. | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. |
| Length of Hospital Stay. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard B Knight, MD | San Antonio Uniformed Services Health Education Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health System | San Antonio | Texas | 78205 | United States | ||
| Methodist Healthcare System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine | Surgical site infiltration of 0.25% bupivacaine. Bupivacaine |
| FG001 | Liposomal Bupivacaine | Surgical site infiltration of liposomal bupivacaine. liposomal bupivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Six patients were excluded from the 0.25% bupivacaine group: one for seizures; four for NSAID and/or PCA use; and one for incomplete data. Nine patients were excluded from the liposomal bupivacaine group; one for remaining intubated overnight; four for surgical complications; three for a hospital stay >5 days due to ileus; and one for NSAID use.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine | Surgical site infiltration of 0.25% bupivacaine. Bupivacaine |
| BG001 | Liposomal Bupivacaine | Surgical site infiltration of liposomal bupivacaine. liposomal bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| 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 | Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay | Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay | Posted | Median | Inter-Quartile Range | mg (morphine equivalents) | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. |
|
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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 | Bupivacaine | Surgical site infiltration of 0.25% bupivacaine. Bupivacaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Knight, MD | USAF | +44 1638 528186 | richard_b_knight@yahoo.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
Length of hospital stay. |
| All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. |
| Time to First Opioid Use. | Time to first opioid use. | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. |
| San Antonio |
| Texas |
| 78229 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
|
|
|
| Secondary | Visual Analog Pain Scores. | Visual analog pain scores. | Not Posted | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. |
| Secondary | Length of Hospital Stay. | Length of hospital stay. | Not Posted | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. |
| Secondary | Time to First Opioid Use. | Time to first opioid use. | Not Posted | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Liposomal Bupivacaine | Surgical site infiltration of liposomal bupivacaine. liposomal bupivacaine | 0 | 106 | 0 | 106 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |