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A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores.
This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Experimental | Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine. |
|
| Placebo | Placebo Comparator | Participants will have bilateral TAP catheters placed along with continuous infusion of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine HCL | Drug | Ropivacaine injected after placement of catheters, then infused during the operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Pain scores from the visual analog scale | Days 0-7 following the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of anesthetic | MAC of inhalational agent, or total amount of IV anesthetic used during the operation | During the operation |
| Amount of narcotic administered postoperatively | Amount of morphine equivalents per day measured after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Douglas Overbey, MD | Contact | 573-225-7728 | douglas.overbey@ucdenver.edu | |
| Thomas Robinson, MD | Contact | 303-399-8020 Ext. 2952 | thomas.robinson@ucdenver.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Robinson, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Veterans Affairs Medical Center | Recruiting | Denver | Colorado | 80221 | United States |
No sharing
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Randomized Controlled Double Blind Trial
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"Study drug" label of drug
| sodium chloride | Drug | Placebo |
|
|
| Days 0-7 postop |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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