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

This study has been withdrawn prior to enrollment.

(The study was not feasible to perform at one institution with the amount of subjects that were needed to complete it.)

Sponsor:

Information provided by (Responsible Party):

Stuart Hart, Ochsner Health System

ClinicalTrials.gov Identifier:

NCT01217580

First received: October 7, 2010

Last updated: October 25, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 7, 2010

Last Updated Date

October 25, 2011

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

hydromorphone consumed by patient controlled analgesia in the first 24 hours after cesarean delivery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01217580 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The presence and severity of pain, nausea, and sedation will be assessed at 2, 4, 6, 12 and 24 hours after the TAP blocks.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Cesarean Section

Intervention ^ICMJE

Drug: 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
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

Study Arm (s)

Experimental: 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.

Intervention: Drug: 0.5% ropivacaine
Placebo Comparator: 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.

Intervention: Drug: 0.9% sodium chloride

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01217580

Other Study ID Numbers ^ICMJE

2010.091.C, PI-Hart

Has Data Monitoring Committee

Yes

Responsible Party

Stuart Hart, Ochsner Health System

Study Sponsor ^ICMJE

Ochsner Health System

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stuart Hart, MD

Ochsner Clinic Foundation

Information Provided By

Ochsner Health System

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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