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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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The purpose of this study is to learn how well Liposomal Bupivacaine (Exparelâ„¢) controls post-operative pain in patients undergoing both open and laparoscopic (minimally invasive) abdominal hernia repair surgery.
When a person has surgery, there are a few different standard care options for pain relief. Anesthetic (numbing) drugs can be used to cause a loss of feeling in or around a wound but the effect of the numbing medication can be undone.Pain relieving drugs such as acetaminophen (Tylenol), non-steroidal anti-inflammatory drugs (NSAIDs), and opioid (narcotic) medications can also be taken by mouth or through a vein in your arm (intravenous IV.) However, both NSAIDs & Opioid drugs can produce negative side effects such as serious difficulty breathing, stopping breathing altogether, low blood pressure, nausea, vomiting, itching, and constipation.
Bupivacaine is one of the commonly used longer-acting numbing medicines (anesthetics). The effect of Bupivacaine or other anesthetics is limited to usually no more than 12 hours when injected around the area of the incision during surgery. Liposomal Bupivacaine (Exparel) could provide good, continuous and longer pain relief than current therapies/treatments commonly used. This can possibly improve patient satisfaction and time to normal activities such as walking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 1 will have an open surgery for abdominal hernia repair. |
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| Treatment Group 2 | Experimental | Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 2 will have a laparoscopic abdominal hernia repair. |
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| Control Group 1 | Active Comparator | Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment. |
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| Control Group 2 | Active Comparator | Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With Pain Management After Surgery | Satisfaction measured with composite score that includes score from the Likert scale and opioid consumption/satisfaction log. Satisfaction was rated on a scale of 1-5, with 1 being "strongly disagree"/not satisfied with pain control and 5 being "strongly agree"/satisfied with pain control. Patients filled out the log on days 1-4 after surgery and at a 7-14 day follow up visit. | Change from Surgery to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Length of Time in Post-anesthesia Care Unit (PACU) | Length of time subjects stayed in the PACU following surgery | Up to 385 minutes after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Moncure, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laparoscopic Treatment Arm | Laparoscopic abdominal hernia repair with Exparel |
| FG001 | Laparoscopic Control Arm | Laparoscopic abdominal hernia repair without Exparel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ketorolac |
| Drug |
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| laparoscopic abdominal hernia repair | Procedure |
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| an open surgery for abdominal hernia repair | Procedure |
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| FG002 | Open Treatment Arm | Open abdominal hernia repair with Exparel |
| FG003 | Open Control Arm | Open abdominal hernia repair without Exparel |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Laparoscopic Treatment Arm | All patients 18 and older presenting with an abdominal hernia requiring laparoscopic repair were screened for inclusion. |
| BG001 | Laparoscopic Control Arm | All patients 18 and older presenting with an abdominal hernia requiring laparoscopic repair were screened for inclusion. |
| BG002 | Open Treatment Arm | All patients 18 and older presenting with an abdominal hernia requiring open surgical repair were screened for inclusion. |
| BG003 | Open Control Arm | All patients 18 and older presenting with an abdominal hernia requiring open surgical repair were screened for inclusion. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Different arms have different age ranges and number of participants. | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Patient Satisfaction With Pain Management After Surgery | Satisfaction measured with composite score that includes score from the Likert scale and opioid consumption/satisfaction log. Satisfaction was rated on a scale of 1-5, with 1 being "strongly disagree"/not satisfied with pain control and 5 being "strongly agree"/satisfied with pain control. Patients filled out the log on days 1-4 after surgery and at a 7-14 day follow up visit. | Posted | Median | Inter-Quartile Range | score on a scale | Change from Surgery to Day 14 |
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| Secondary | Total Length of Time in Post-anesthesia Care Unit (PACU) | Length of time subjects stayed in the PACU following surgery | Posted | Median | Inter-Quartile Range | minutes | Up to 385 minutes after surgery |
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Patients were assessed for AE/SAE daily while inpatient and then through patient report during the 7-14 day follow-up visit.
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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 | Open Control Arm | Patients were assessed for AE/SAE daily while inpatient and then through patient report during the 7-14 day follow-up visit. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Open Treatment Arm | Patients were assessed for AE/SAE daily while inpatient and then through patient report during the 7-14 day follow-up visit. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Laparoscopic Control Arm | Patients were assessed for AE/SAE daily while inpatient and then through patient report during the 7-14 day follow-up visit. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Laparoscopic Treatment Arm | Patients were assessed for AE/SAE daily while inpatient and then through patient report during the 7-14 day follow-up visit. | 0 | 7 | 0 | 7 | 0 | 7 |
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Trial was ended prematurely due to administrative constraints and only reached half of the projected enrollment numbers.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Moncure, MD | University of Kansas Medical Center | 913-588-1240 | mmoncure@kumc.edu |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Units | Counts |
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| Participants |
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