Pain Relief Study of Ultrasound Guided Transverse Abdominis Plane(TAP)Block

Study Overview
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Brief Summary
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The purpose of this study is to determine if injecting a local anesthetic, or numbing medication, above each hip will decrease the amount of narcotic pain medicine that is typically required by a patient after a cesarean delivery. Ultrasound pictures will be used to guide placement of this injection. Either ropivicaine (a type of numbing medication called a local anesthetic) or a placebo (saline) will be injected. For 24 hours, you will be given a button to press when you have pain. When the button is pressed, you will be given a small amount of pain medication called hydromorphone through your IV. You will also be given a pain medication called ketorolac through your IV every 8 hours for 24 hours after surgery.

Official Title
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Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane Block After Cesarean Delivery in Patients With a BMI > 30

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: 0.5% ropivacaine
* Drug: 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or over ASA class 1 , 2 or 3 BMI greater than 30 kg/m2 (as recorded at the patient's last clinic appointment or as measured on the day of delivery) Scheduled for cesarean section via Pfannenstiel incision (with or without a tubal ligation) 150 cm or taller Informed consent obtained Exclusion Criteria: ASA class 4 Age under 18 Relevant drug allergy Contraindication to spinal anesthesia Height < 150 cm Patient receiving medical therapies considered to result in a tolerance to opioids Any other major surgical procedure performed other than cesarean delivery with or without tubal ligation Patient with relevant contraindications to ketorolac, such as history of gastrointestinal bleeding or impaired renal function Patient refusal

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 ml per side of 0.5% ropivacaine<br>Ultrasound guided TAP blocks will be performed once patient is in the recovery area. Patients will be placed on their back with their hands resting comfortably above their head. Using an ultrasound guided technique, the ultrasound probe will be positioned on abdominal until the three lateral abdominal wall muscles and TAP are clearly imaged. A two or four inch, 20 gauge needle will be advanced using an in-plane technique. After visual confirmation that the needle tip is in the TAP, 1 ml of preservative free 0.9% sodium chloride will be injected to reconfirm correct placement in the TAP. Then 20 ml of 0.5% ropivacaine will be injected. The procedure will be repeated on the other side. | Drug: 0.5% ropivacaine<br>* 20ml each side of the hip of 0.5% ropivacaine into the transverse abdominis plane after patient is brought to the recovery area after elective cesarean delivery<br>|
| Placebo Comparator: 20 ml per side of 0.9% sodium chloride<br>Ultrasound guided TAP blocks will be performed once patient is in the recovery area. Patients will be placed on their back with their hands resting comfortably above their head. Using an ultrasound guided technique, the ultrasound probe will be positioned on abdominal until the three lateral abdominal wall muscles and TAP are clearly imaged. A two or four inch, 20 gauge needle will be advanced using an in-plane technique. After visual confirmation that the needle tip is in the TAP, 1 ml of preservative free 0.9% sodium chloride will be injected to reconfirm correct placement in the TAP. Then 20 ml of 0.9% preservative free sodium chloride will be injected. The procedure will be repeated on the other side. | Drug: 0.9% sodium chloride<br>* 20ml each side of the hip of 0.9% sodium chloride into the transverse abdominis plane after patient is brought to the recovery area after elective cesarean delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hydromorphone consumed by patient controlled analgesia in the first 24 hours after cesarean delivery |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorical pain scores and Visual Analog Scale (VAS) pain scores (at rest and with movement), nausea and sedation will be assessed to evaluate narcotic side effects |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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c-section, cesarean section, TAP block, pain, pain after delivery, pain after C-section, pain after C-section delivery, pain after cesarean delivery, pain after cesarean