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| ID | Type | Description | Link |
|---|---|---|---|
| DDI.FY13.07 | Other Identifier | Digestive Disease Institute/Ferguson Clinic |
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The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Block Experal | Experimental | Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally. |
|
| No TAP Block | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score | Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience. | participants will be followed for the duration of hospital stay, an expected average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Narcotic Use | Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups. | participants will be followed for the duration of hospital stay, an expected average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications. | Any postoperative complications within 30 days of procedure, including death will be recorded. | participants will be followed for the duration of hospital stay, and 30 days after discharge. |
| Length of Hospital Stay. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAP Block Arm | Twenty five patients randomized to this arm. A volume of 7.5 ml of bupivacaine liposome injectable suspension was used for each side of the TAP blocks so that a total of 15 ml were utilized. The remaining 5 ml of bupivacaine liposome injectable suspension were diluted with 30 ml of sterile preservative free saline and used for local infiltration of the laparoscopic wound |
| FG001 | no TAP Block Arm | Twenty five patients randomized to this arm. did not receive TAP block. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAP Block | Patient received TAP block |
| BG001 | no TAP Block | patient did not received TAP block |
| 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 | Postoperative Pain Score | Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience. | Posted | Mean | Full Range | units on a scale | participants will be followed for the duration of hospital stay, an expected average of 4 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 | TAP Block | adverse event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nezar Jrebi | Spectrum Health | 507-271-8284 | jrebi.nezar@hotmail.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| TAP Block | Procedure | no intervention will be done to this arm. |
|
Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.
| participants will be followed for the duration of hospital stay, an expected average of 4 days |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Postoperative Narcotic Use | Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups. | Posted | Mean | Full Range | mg | participants will be followed for the duration of hospital stay, an expected average of 4 days |
|
|
|
| Other Pre-specified | Postoperative Complications. | Any postoperative complications within 30 days of procedure, including death will be recorded. | Posted | Number | participants | participants will be followed for the duration of hospital stay, and 30 days after discharge. |
|
|
|
| Other Pre-specified | Length of Hospital Stay. | Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge. | Posted | Mean | Full Range | days | participants will be followed for the duration of hospital stay, an expected average of 4 days |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | no TAP Block | adverse event | 0 | 25 | 0 | 25 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |