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Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese patients (BMI >35) undergoing laparoscopic bariatric surgery for weight loss will significantly reduce opioid use in the recovery room
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP, Bupivacaine | Experimental | This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. |
|
| No intervention | No Intervention | General anesthesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transverse abdominal plane block | Procedure | Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Opioid Usage | The amounts of opioids used by the patient will be collected by a person blinded to the allocation group | 24 hour after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score Assessed With Visual Analog Score (VAS) | Visual Analog Score (VAS) scores correlate to Pain scores (0-10, 0 being no pain and 10 being the worst pain). VAS will be taken within 30 minutes of arrival to post anesthesia care unit (PACU) | 30 minutes within arrival to PACU |
| Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karina Gritsenko, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAP, Bupivacaine | This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. |
| FG001 | No Intervention | General anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAP, Bupivacaine | This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Post Operative Opioid Usage | The amounts of opioids used by the patient will be collected by a person blinded to the allocation group | Posted | Median | Inter-Quartile Range | morphine equivalent | 24 hour after surgery |
|
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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 | TAP, Bupivacaine | This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karina Gritsenko | Montefiore Medical Center | 718-920-7246 | kgritsen@montefiore.org |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Ropivacaine | Drug | Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. |
|
The number of participants experiencing nausea will be assessed by chart review |
| Up to 5 hours |
| Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review | The number of participants experiencing vomiting will be assessed by chart review | Up to 5 hours |
| BG001 | No Intervention | General anesthesia |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| No Intervention |
General anesthesia |
|
|
| Secondary | Pain Score Assessed With Visual Analog Score (VAS) | Visual Analog Score (VAS) scores correlate to Pain scores (0-10, 0 being no pain and 10 being the worst pain). VAS will be taken within 30 minutes of arrival to post anesthesia care unit (PACU) | Posted | Median | Inter-Quartile Range | units on a scale | 30 minutes within arrival to PACU |
|
|
|
| Secondary | Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review | The number of participants experiencing nausea will be assessed by chart review | Posted | Count of Participants | Participants | Up to 5 hours |
|
|
|
| Secondary | Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review | The number of participants experiencing vomiting will be assessed by chart review | Posted | Count of Participants | Participants | Up to 5 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | No Intervention | General anesthesia | 0 | 11 | 0 | 11 | 0 | 11 |
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| D000588 |
| Amines |