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

Ochsner Health System

Status: Withdrawn

Conditions: Cesarean Section

Treatments: Drug: 0.9% sodium chloride; Drug: 0.5% ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01217580

PI-Hart (Other Identifier)

2010.091.C

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

20 ml per side of 0.5% ropivacaine

Experimental group

Description:

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.

Treatment:

Drug: 0.5% ropivacaine

20 ml per side of 0.9% sodium chloride

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9% sodium chloride