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Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to prolong the effective duration of analgesia in several different peripheral nerve blocks. The study will examine, in a blinded, prospective and randomized fashion, whether the addition of dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will compare local anesthetic with and without the addition of dexamethasone in the TAP block.
The study will be done in two phases. In the first phase, patients will be randomized to receive either 20 cc of 0.125% bupivicaine with or without 2 mg of dexamethasone on each side of their abdomen (40 cc and 4 mg in total) and patients who receive the dexamethasone will be compared with patients who did not receive it. In the second phase, we will assess whether patients can serve as their own controls by adding dexamethasone only to one side of the block (one side of the abdomen) and comparing pain relief/efficacy with the contra-lateral plain local anesthetic effect. The study will assess pain relief, opioid consumption, level of blockade, and operator's prospective assessment of likely efficacy, based on the ultrasound visualization of the local anesthetic injection as compared with actual efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Experimental | Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. |
|
| Treatment Arm 2 | Active Comparator | Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Request of Additional Analgesia | Documenting the time required by patients to the first request of additional analgesia. | 24 hours post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Efficacy of the TAP Block by Measuring Visual Analog Scales, Total Opioid Use During the First 24 Hours Post-op, and Provider Assessments to Recognize the Overall Efficacy of the Procedure With and Without Dexamethasone Adjunct. | 24 hours post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Sternlicht, MD | St. Elizabeth's Medical Center of Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth's Medical Center of Boston | Boston | Massachusetts | 02135 | United States |
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No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm 1 | Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. |
| FG001 | Treatment Arm 2 | Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm 1 | Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. |
| BG001 | Treatment Arm 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Time to First Request of Additional Analgesia | Documenting the time required by patients to the first request of additional analgesia. | No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable. | Posted | 24 hours post-op |
|
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No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.
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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 | Treatment Arm 1 | Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghan Cashman, IRB Manager | Steward St. Elizabeth's Medical Center | 617-789-2804 | 2804 | meghan.cashman@steward.org |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| TAP block |
| Procedure |
Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side |
|
Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side |
|
| Secondary | Assess the Efficacy of the TAP Block by Measuring Visual Analog Scales, Total Opioid Use During the First 24 Hours Post-op, and Provider Assessments to Recognize the Overall Efficacy of the Procedure With and Without Dexamethasone Adjunct. | No data are available for this study, due to the fact that the PI and study staff have left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable. | Posted | 24 hours post-op |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Treatment Arm 2 | Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |