Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain

Study Overview
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Brief Summary
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Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.

Detailed Description
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Participants in the study will be randomized to TAP block with 0.5% or 0.25% bupivacaine or with placebo (normal saline). The number of PCA bolus used within 24 hours post cesarean section will be compared between the groups.

Official Title
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Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).

Conditions
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Obstetrical Complications From Sedation During Parturition

Intervention / Treatment
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* Drug: Bupivicaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia Exclusion Criteria: They are unable or are unwilling to take part in the study They have a history of allergy to any of the medications to be used in the study They have a history of drug abuse or chronic pain or opioid use They weigh less than 60kg They have a multiple gestation, placental disease, preeclampsia other disease of pregnancy They have a contraindication to neuraxial anesthesia (i.e., bleeding problems, bacteremia, etc.) They are unable to understand instructions or questions related to the study ASA III or IV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivicaine 0.5%<br>Drug Bupivacaine 0.5% | Drug: Bupivicaine<br> <br> |
| Experimental: Bupivicaine 0.25%<br>Drug Bupivacaine 0.25% | Drug: Bupivicaine<br> <br> |
| Placebo Comparator: Normal Saline<br>Saline Normal | Drug: Bupivicaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain | In Patient Controlled analgesia (PCA) system, the patient receives a preset dose of morphine by pressing a button on a computerized pump that is connected to an IV catheter. With PCA the patient may receive a small continuous flow of morphine and add more morphine as needed to provide a more constant level of comfort. In this study, we will compare the number of PCAs used by the participants in each arm | The first post operative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the pain score as measured by Visual Analog Scale (VAS) | Visual Analog Scale (VAS) is a numeric scale to measure the pain intensity from 0 to 10, where 0 = no pain, (1-3) = mild pain, (4-6) = moderate pain, and (7-10) = severe pain. The worst imaginable pain = 10 | The first post operative 24 hours |