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| ID | Type | Description | Link |
|---|---|---|---|
| CO11701 | Other Identifier | UWCCC | |
| 2011-0274 | Other Identifier | Institutional Review Board | |
| A532820 | Other Identifier | UW Madison | |
| SMPH\OBSTET & GYNECOL ONC | Other Identifier | UW Madison | |
| NCI-2011-03675 | Registry Identifier | NCI Trial ID |
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This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivicaine | Experimental | TAP block with bupivicaine/epinephrine placed prior to surgery. |
|
| Placebo | Placebo Comparator | TAP block with placebo placed prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivicaine | Drug | The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis |
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Pain scores by the Visual Analog Scale (VAS) [0-5, where 0 is no pain and 5 is extreme] and Wisconsin Brief Pain Inventory (BPI) [where 0 is no pain and 10 is the most painful], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Kushner, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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A total of 75 patients agreed to participate in the study. Eight patients did not meet inclusion criteria for the study, 2 patients were excluded from the analysis secondary to intraoperative conversion to laparotomy, and 1 additional patient was excluded because the robot was unavailable. This left a total of 64 subjects who completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivicaine | TAP block with bupivicaine/epinephrine placed prior to surgery. Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis |
| FG001 | Placebo | TAP block with placebo placed prior to surgery Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The treatment group, who received TAP block placement, was younger than the saline injection group, on average (55.2 versus 62.1, P = 0.028).
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivicaine | TAP block with bupivicaine/epinephrine placed prior to surgery. Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis |
| 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 | 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents | Posted | Mean | Standard Deviation | mg | 24 hours |
|
2-4 weeks post-op
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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 | Bupivicaine | TAP block with bupivicaine/epinephrine placed prior to surgery. Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis |
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Unilateral placement of block may decrease overall effectiveness. Sample size was small, from single institution, and encompassed a variety of diagnoses and procedures. Analysis also included intraoperative medications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Kushner | University of Wisconsin Hospitals and Clinics | 608-263-0796 | dmkushner@facstaff.wisc.edu |
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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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|
| Placebo | Drug | The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline. |
|
| from 2 hours post-op to the afternoon/evening of post-op day #1 |
| BG001 | Placebo | TAP block with placebo placed prior to surgery Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Pain Scores | Pain scores by the Visual Analog Scale (VAS) [0-5, where 0 is no pain and 5 is extreme] and Wisconsin Brief Pain Inventory (BPI) [where 0 is no pain and 10 is the most painful], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score. | Posted | Mean | 95% Confidence Interval | units on a scale | from 2 hours post-op to the afternoon/evening of post-op day #1 |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Placebo | TAP block with placebo placed prior to surgery Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline. | 0 | 33 | 0 | 33 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |