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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

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.

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Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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20 ml per side of 0.5% ropivacaine

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.

Group Type EXPERIMENTAL

0.5% ropivacaine

Intervention Type DRUG

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

20 ml per side of 0.9% sodium chloride

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.

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

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

Interventions

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0.5% ropivacaine

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

Intervention Type DRUG

0.9% sodium chloride

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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No