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A better study with a better drug was started and thus this study was terminated
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With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section).
With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section). The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. The investigators will inject the local anesthetic ropivacaine into this space to freeze these nerves and prevent pain following c-section. The investigators will compare three different doses of ropivacaine (0.5%, 0.25%, 0%) to determine the lowest dose that controls pain with the fewest side effects. Participants in this study will receive 0.5% (Group 1), 0.25% (Group 2), or 0% (Group 3) ropivacaine TAP blocks to control pain after c-section. At 2, 6, 12, 24, and 48 hours after cesarean section visual analog pain scores (VAS) for pain on movement, pain at rest, and pain with cough will be collected along with the time to first postoperative analgesic request, patient satisfaction scores, and patient demographics. The analgesic regimen will be considered effective if it provides lower average visual analog scores for pain with movement. Secondary outcomes will be higher patient satisfaction, better pain control, fewer postoperative analgesic requests, and fewer side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - 0.5% Ropivacaine | Active Comparator | Patients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin |
|
| Group 2 - 0.25% Ropivacaine | Active Comparator | Patients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin |
|
| Group 3 - No Tap Block | No Intervention | Patients will not receive a TAP BLOCK |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| POSTOPERATIVE PAIN | Severity of postoperative pain will be assessed using(VAS) scale. Post-operative pain scale name: Visual Analog Scale (0-10) with 0 being no-pain and 10 being maximum pain. | 48 hours |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KALPANA TYAGARAJ, MD | MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - 0.5% Ropivacaine | Patients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients |
| FG001 | Group 2 - 0.25% Ropivacaine | Patients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients |
| FG002 | Group 3 - No Tap Block | Patients will not receive a TAP BLOCK |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - 0.5% Ropivacaine | Patients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | POSTOPERATIVE PAIN | Severity of postoperative pain will be assessed using(VAS) scale. Post-operative pain scale name: Visual Analog Scale (0-10) with 0 being no-pain and 10 being maximum pain. | Posted | Mean | Standard Deviation | score on a scale | 48 hours |
|
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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 | Group 1 - 0.5% Ropivacaine | Patients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kalpana Tyagaraj | Maimonides Medical Center | 718-283-1753 | KTyagaraj@maimonidesmed.org |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| BG001 |
| Group 2 - 0.25% Ropivacaine |
Patients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients |
| BG002 | Group 3 - No Tap Block | Patients will not receive a TAP BLOCK |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Group 3 - No Tap Block | Patients will not receive a TAP BLOCK |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Group 2 - 0.25% Ropivacaine | Patients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Group 3 - No Tap Block | Patients will not receive a TAP BLOCK | 0 | 18 | 0 | 18 | 0 | 18 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |