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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
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Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under direct visualization will be compared it to a standard anesthetic technique (control) following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are hypothesizing that the bilateral TAP block and preperitoneal instillation of local anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction and post-operative pain control when compared to a standard anesthetic technique (no regional technique).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound guided bilateral TAP block | Active Comparator | Ultrasound guided TAP Block with local anesthetic and dexamethasone. |
|
| Instillation of surgical site with local anesthestic. | Active Comparator | Instillation of surgical site under direct visualization with local anesthetics and dexamethasone. |
|
| Control Group | Placebo Comparator | Standard anesthetic technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transversus abdominis plane block (TAP BLOCK) | Procedure | Ultrasound guided TAP block with local anesthetics and dexamethasone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Assessment will be done postoperatively using a Quality of Recovery 40 (QoR-40) questionnaire after surgery. | Post-operatively (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Total opioid use in the post anesthesia care unit (PACU) and the period following surgery. | Post-operatively (Day 0 to 1) |
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Sakamoto, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush Veterans Affairs Medical Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27653293 | Derived | Sakamoto B, Harker G, Eppstein AC, Gwirtz K. Efficacy of Local Anesthetic With Dexamethasone on the Quality of Recovery Following Total Extraperitoneal Bilateral Inguinal Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2016 Dec 1;151(12):1108-1114. doi: 10.1001/jamasurg.2016.2905. |
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| Instillation of surgical site with local anesthetic. | Procedure | Instillation of surgical site with local anesthetics and dexamethasone. |
|
| Opioid IV medications (Control) | Procedure | Standard anesthetic technique. |
|
Pain scores in the PACU |
| Post-operatively (day 0) |
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Pain scores post-operatively. | Post-operatively (day 1) |
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Any side effects secondary to any of the post-operative pain procedures. | Post-operatively (day 0 to 1) |
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Time spent in the PACU | Post-operatively (day 0) |
| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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