Clinical trial NCT01217580: Pain Relief Study of Ultrasound Guided Transverse Abdominis Plane(TAP)Block
Official title: Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane Block After Cesarean Delivery in Patients With a BMI > 30
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cesarean Section
Keywords: 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
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: hydromorphone consumed by patient controlled analgesia in the first 24 hours after cesarean delivery
timeFrame: 24 hours
Secondary outcomes:
measure: 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
timeFrame: 24 hours
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Stuart Hart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saravanakumar K, Rao SG, Cooper GM. Obesity and obstetric anaesthesia. Anaesthesia. 2006 Jan;61(1):36-48. doi: 10.1111/j.1365-2044.2005.04433.x.
citation: American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available.
citation: McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
citation: McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
citation: Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22.
citation: Tran TM, Ivanusic JJ, Hebbard P, Barrington MJ. Determination of spread of injectate after ultrasound-guided transversus abdominis plane block: a cadaveric study. Br J Anaesth. 2009 Jan;102(1):123-7. doi: 10.1093/bja/aen344.
citation: El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.