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This study was conducted to compare the effectiveness of two local pain control methods in bariatric patients by assessing the amount of postoperative pain and amount of postoperative pain medications needed. This information was used to determine which local anesthetic provided the best pain control.
The investigators have previously utilized the On-Q® pain ball to obtain local control by continuous delivery of bupivacaine to pain fibers at the incision site. On-Q makes use of an implanted catheter and a continuous infusion pump that the patient carries with them typically for 48-72 hours after surgery. EXPAREL is a long-acting liposomal delivery vehicle that extends the life of bupivacaine in the surgical site for up to 72 hours. It can be injected in all trocar sites and offers another potential solution to patient pain control without the need for a catheter and the hardware needed to deliver the local anesthetic. Patient NRS (numerical rating scale) scores for postoperative pain and total medication consumed were used to assess the differences between the two treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPAREL | Active Comparator | EXPAREL (bupivacaine liposome injectable suspension) |
|
| On-Q Pain Ball | Active Comparator | Device for delivering bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL | Drug |
|
| |
| On-Q Pain Ball |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) pain intensity scores | The NRS was from 0 = no pain and 10 = worst pain. | 4-6 hours postoperatively and in the mornings of postoperative Day 1 and Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid consumption | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franchell Richard-Hamilton, MD | Bariatric Medical Institute of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bariatric Medical Institute of Texas | San Antonio | Texas | 78240 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2015 | |
| Reset | Jan 22, 2015 | |
| Release | Aug 6, 2015 | |
| Reset | Aug 13, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2015 | Jan 22, 2015 | |||
| Aug 6, 2015 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic 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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| Drug |
bupivacaine HCl 0.25% |
|
|
| Aug 13, 2015 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D000588 |
| Amines |