NCT02292667

Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery

Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ETAP study aim to assess the effect of the addition of an ultrasound-guided transversus abdominis plane (TAP) block to a multimodal intravenous analgesia protocol on the postoperative pain control in open surgical repair of abdominal aortic aneurysm. The ETAP study is a single-center open-label randomized controlled trial. Half of patients included will receive the association of TAP block and multimodal intravenous analgesia, and the other half will receive the multimodal intravenous analgesia alone. The multimodal intravenous analgesia includes intravenous paracetamol and intravenous patient-controlled analgesia with morphine.

Detailed description

The open repair of abdominal aortic aneurysm (AAA) is a painful surgery. Patients suffering from AAA are at high risk of perioperative cardiovascular and pulmonary complications. It has been previously suggested that a bad perioperative pain control could increase the incidence of such complications. Intravenous patient-controlled analgesia (PCA) with morphine is widely considered as the gold standard treatment of the postoperative pain in open repair of AAA. High dose of morphine are often required and could delay the postoperative recovery and discharge. Side effects of morphine, such as respiratory depression, nausea, vomiting or pruritus, are responsible for patient discomfort and dissatisfaction when high doses are used. The efficacy of the ultrasound-guided transversus abdominis plane (TAP) block has been described for pain management following abdominal surgery, such as gastrectomy or kidney transplantation. The efficacy of the association of TAP block and PCA with morphine was higher than multimodal intravenous analgesia including PCA with morphine and than the combination of PCA with morphine and epidural analgesia. To our knowledge, the efficacy of the ultrasound-guided TAP block has never been studied for the postoperative pain control in AAA surgery.

Conditions

• Aortic Aneurysm, Abdominal
• Pain
• Anesthesia, Local

Interventions

Type	Name	Description
PROCEDURE	TAP block	The aim of the Transversus Abdominis Plane (TAP) Block is to deposit local anesthetic in the plane between the internal oblique and the transversus abdominis muscles targeting the spinal nerves in this plane. The local anesthetic used in the ETAP study is Ropivacaine 0.375%. 2 ultrasound-guided injections of 10 ml will be performed on each side of the abdominal wall: 1 subcostal injection and 1 supra-iliac injection.
DRUG	PCA with Chlorhydrate of Morphine	Doses of 1 mg of Chlorhydrate of Morphine will be delivered intravenously by the Patient Controlled Analgesia (PCA) pump. The PCA pump is a computerized pump which contains a syringe of 1 mg/ml of Chlorhydrate of Morphine as prescribed by the physician in charge of the patient, and connected directly to a patient's intravenous line. Doses of Chlorhydrate of Morphine can be self-administered by the patient as needed by the having the patient press a button.
DRUG	Acetaminophen	1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2014-11-17
• Last updated: 2016-08-12

Locations

1 site across 1 country: France