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This study has been withdrawn prior to enrollment.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

October 7, 2010
October 25, 2011
October 2010
October 2011   (final data collection date for primary outcome measure)
hydromorphone consumed by patient controlled analgesia in the first 24 hours after cesarean delivery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01217580 on ClinicalTrials.gov Archive Site
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 ]
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 ]
The presence and severity of pain, nausea, and sedation will be assessed at 2, 4, 6, 12 and 24 hours after the TAP blocks.
Not Provided
Not Provided
 
Pain Relief Study of Ultrasound Guided Transverse Abdominis Plane(TAP)Block
Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane Block After Cesarean Delivery in Patients With a BMI > 30

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cesarean Section
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
50
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01217580
2010.091.C, PI-Hart
Yes
Stuart Hart, Ochsner Health System
Ochsner Health System
Not Provided
Principal Investigator: Stuart Hart, MD Ochsner Clinic Foundation
Ochsner Health System
October 2011

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