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Inadequate patient population to complete enrollment
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The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown.
The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group
Group 1 will be administered 266 mg of Exparel, diluted to 30 mL. Group 2 will be given 28 mL of 0.375% bupivacaine and 8mg/2 mL dexamethasone.Before injection of the study medication, 2mL of normal saline with be injected under ultrasound visualization to ensure needle tip is in the transversus abdominis plane.Randomization will occur following the written informed consent and prior to the start of the surgical procedure. Postoperatively, study patients will receive intravenous acetaminophen 1000mg every 8 hours for 3 doses, then oral acetaminophen 650mg every 6 hours. Subjects will also have patient-controlled analgesia (PCA) with morphine or hydromorphone. The research staff recording data will be blinded to the treatment group. Demographic data will be recorded, including age, date of birth, height and weight to ensure similarity between the two groups. A medical history will be obtained as well as surgical and anesthesia details. Study patients will be followed for 72 hours postoperatively to record the amount of opioid consumption, as well as other pain score data using the Visual Analogue Scale (VAS).The subject's participation will end 72 hours after surgery. A telephone interview will occur with the subject if hospital discharge occurs prior to 72 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-Exparel | Active Comparator | Bupivacaine Extended-Release Liposome Injection (Exparel)will be administered via TAP block procedure |
|
| Group 2-Bupivacaine and Dexamethasone IV | Active Comparator | Bupivacaine and Dexamethasone Injection will be administered via TAP block procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Extended-Release Liposome Injection (Exparel) | Drug | 266mg/30mL of Exparel will be injected via unilateral TAP block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Opioid Consumption | The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group. | Post Surgery (Up to 72 Hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Analogue Scale (VAS) Pain Score at Rest | The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain. | Post-Surgery 24 Hours, 48 Hours, 72 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colette Curtis, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital |
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Participants were recruited from the Emory University Hospital and the Emory University Hospital Midtown between July 2014 through June 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1-Exparel | Bupivacaine Extended-Release Liposome Injection (Exparel) were administered via TAP block procedure Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block. |
| FG001 | Group 2-Bupivacaine and Dexamethasone IV | Bupivacaine and Dexamethasone Injection were administered via TAP block procedure. Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1-Exparel | Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block |
| BG001 | Group 2-Bupivacaine and Dexamethasone IV |
| 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 | Mean Opioid Consumption | The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group. | Posted | Mean | Standard Deviation | milligrams | Post Surgery (Up to 72 Hours) |
|
Adverse events were collected throughout the duration of the study (1 year).
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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 | Group 1-Exparel | Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Colette Curtis | Emory University | 404-778-3900 | ccurti3@emory.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D002123 | Calcium Dobesilate |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine and Dexamethasone Injection | Drug | As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block. |
|
| IV Acetaminophen | Drug | Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses. |
|
| Oral Acetaminophen | Drug | Oral acetaminophen 650 mg every 6 hours. |
|
| Mean Visual Analogue Scale (VAS) Pain Score With Movement | The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain. | Post-Surgery 24 Hours, 48 Hours, 72 Hours |
| Mean Time of First Opioid Use | The time of first opioid use after surgery will be recorded for up to 72 hours. | Post-surgery (Up to 72 Hours) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
Bupivacaine and Dexamethasone Injection was administered via TAP block procedure. Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Mean Visual Analogue Scale (VAS) Pain Score at Rest | The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain. | Posted | Mean | Standard Deviation | units on a scale | Post-Surgery 24 Hours, 48 Hours, 72 Hours |
|
|
|
| Secondary | Mean Visual Analogue Scale (VAS) Pain Score With Movement | The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain. | Posted | Mean | Standard Deviation | units on a scale | Post-Surgery 24 Hours, 48 Hours, 72 Hours |
|
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| Secondary | Mean Time of First Opioid Use | The time of first opioid use after surgery will be recorded for up to 72 hours. | Posted | Mean | Standard Deviation | hours | Post-surgery (Up to 72 Hours) |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Group 2-Bupivacaine and Dexamethasone IV | Bupivacaine and Dexamethasone Injection was administered via TAP block procedure. Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D000588 |
| Amines |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000083 | Acetanilides |
| 72 Hours Post Surgery |
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| 72 Hours Post Surgery |
|