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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Cesarean Section
Drug: 0.5% ropivacaine
Drug: 0.9% sodium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane Block After Cesarean Delivery in Patients With a BMI > 30

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217580

Locations
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Investigators
Principal Investigator: Stuart Hart, MD Ochsner Clinic Foundation
  More Information

Additional Information:
Publications:

Responsible Party: Stuart Hart, Director of Obstetric Anesthesiology, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01217580     History of Changes
Other Study ID Numbers: 2010.091.C, PI-Hart
Study First Received: October 7, 2010
Last Updated: October 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ochsner Health System:
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

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014