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| ID | Type | Description | Link |
|---|---|---|---|
| OCR18951 | Other Identifier | University of Florida |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery.
The purpose of this research study is to compare the ability of the TAPB and RSB to provide anesthesia for overweight and obese patients undergoing abdominal wall surgery. At the present time, this procedure is performed under general anesthesia, which often poses increased risks for overweight and obese individuals. It is not known if these blocks could be used to avoid the use of general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAPB Group | Active Comparator | Compare the instance in the TAPB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing TAPB to anesthetize the abdominal wall. |
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| RSB Group | Active Comparator | Compare the instance in the RSB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing RSB to anesthetize the abdominal wall. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAPB Group | Procedure | Subjects allocated to the TAPB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes between the two groups to provide surgical anesthesia | Assessed by the ability of the TAPB and RSB to provide primary surgical anesthesia | Changes from baseline (pre-op) to 1 hour post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Changes between the two groups assessed by post-operative pain control | Assessed by instances of numerical rating scale pain scores (0-10) | Changes from baseline (post-operative) to 48 hours post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José R Soberón, MD | Malcom Randall VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malcom Randall VA Medical Center | Gainesville | Florida | 32608 | United States |
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| ID | Term |
|---|---|
| D006554 | Hernia, Umbilical |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |
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| ID | Term |
|---|---|
| D018681 | Anesthetics, General |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.
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| RSB Group | Procedure | Subjects allocated to the RSB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared. |
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| conversion to general anesthesia | Procedure | For those who do not respond to TAPB or RSB to allow for completion of the intended procedure. |
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| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |