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A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.
A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries. Subjects of prospective study will be randomly divided using electronic program into two groups:
The first group will receive intraoperative local Liposomal Bupivacaine injection at the port placement site. The control group will receive will local Marcaine (bupivacaine HCl) injection
Primary Outcome Measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. |
|
| Marcaine | Active Comparator | This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively | Postoperative days 1-3 |
| Postoperative Pain Assessment | Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients. | Postoperative day 1 |
| Length of Hospital Stay | Duration of hospital stay after the surgery until time of discharge | Duration of stay in hours |
| Postoperative Complications | Any complication related to the surgery within 30 days | 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Keheila, MD | Loma Linda University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda Medical Center | Loma Linda | California | 92350 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26307232 | Background | Abdelsattar JM, Boughey JC, Fahy AS, Jakub JW, Farley DR, Hieken TJ, Degnim AC, Goede W, Mohan AT, Harmsen WS, Niesen AD, Tran NV, Bakri K, Jacobson SR, Lemaine V, Saint-Cyr M. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol. 2016 Feb;23(2):465-70. doi: 10.1245/s10434-015-4833-4. Epub 2015 Aug 26. | |
| 26056753 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel | This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. |
| FG001 | Marcaine | This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel | This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. |
| BG001 | Marcaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively | During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution. | Posted | Mean | Standard Deviation | morphine equivalent | Postoperative days 1-3 |
|
30-days postoperatively
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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 | Exparel | This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative Ileus | Gastrointestinal disorders | Non-systematic Assessment | Postoperative ileus managed conservatively |
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During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duane Baldwin, MD Director of Urologic Research | Loma Linda University Health | 909 558 4196 | dbaldwin@llu.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 | May 11, 2016 | May 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Marcaine | Drug | This group will receive intraoperative Bupivacaine HCl injection at the surgical site. |
|
|
| Background |
| Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6. |
| 25940854 | Background | White S, Vaughan C, Raiff D, Eward W, Bolognesi M. Impact of liposomal bupivacaine administration on postoperative pain in patients undergoing total knee replacement. Pharmacotherapy. 2015 May;35(5):477-81. doi: 10.1002/phar.1587. Epub 2015 May 4. |
This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Marcaine | This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure. |
|
|
| Primary | Postoperative Pain Assessment | Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients. | During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution. | Posted | Mean | Standard Deviation | units on a scale | Postoperative day 1 |
|
|
|
| Primary | Length of Hospital Stay | Duration of hospital stay after the surgery until time of discharge | During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution. | Posted | Mean | Standard Deviation | Hours | Duration of stay in hours |
|
|
|
| Primary | Postoperative Complications | Any complication related to the surgery within 30 days | During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution. | Posted | Count of Participants | Participants | 30 days postoperatively |
|
|
|
| 0 |
| 63 |
| 6 |
| 63 |
| 0 |
| 63 |
| EG001 | Marcaine | This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. | 0 | 73 | 6 | 73 | 0 | 73 |
|
| Postoperative Bleeding | Surgical and medical procedures | Non-systematic Assessment | Postoperative bleeding requiring blood transfusion |
|
| Postoperative Hypotension | Surgical and medical procedures | Non-systematic Assessment | Postoperative hypotension or dehydration requiring fluid management |
|
| Stricture | Renal and urinary disorders | Non-systematic Assessment | Postoperative stricture requiring dilation |
|
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| D000588 |
| Amines |