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

Cesarean Section Clinical Trial

— TAP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01217580
• Other study ID #: 2010.091.C
• Secondary ID: PI-Hart
• Status: Withdrawn
• Phase: N/A
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2023
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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 ch — View 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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hydromorphone consumed by patient controlled analgesia in the first 24 hours after cesarean delivery		24 hours
Secondary	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		24 hours