Clinical trial NCT02292667: Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery
Official title: Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Aortic Aneurysm, Abdominal
Pain
Anesthesia, Local
Keywords: Transversus Abdominis Plane Block
Postoperative Pain Management
Open Repair of Aortic Abdominal Aneurysm
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status 1, 2 or 3
* Elective surgery for open repair of an aortic abdominal aneurysm performed in the Vascular Surgery Unit of the University Hospital of Besancon
* Informed consent given
* Health medical insurance affiliation

Exclusion Criteria:

* Poor adherence to protocol attended
* Incapacity to consent
* Pregnancy and/or breast feeding
* Endovascular repair of aortic abdominal aneurysm
* Emergent surgery of a rupture or a fissuration of aortic abdominal aneurysm
* Chronic medical treatment by clopidogrel if clopidogrel not stopped 5 days before surgery at least
* Chronic medical treatment by prasugrel if prasugrel not stopped 7 days before surgery at least
* Chronic medical treatment by ticlopidine, inhibitors of phosphodiesterase , inhibitors of glycoprotein IIb/IIIa, adenosine triphosphate analogs or thrombin receptor antagonists
* Congenital or acquired bleeding disorder
* Incapacity to use patient-controlled analgesia device
* Chronic opioid abuse or dependence
* Chronic renal failure defined as a clearance \< 30 ml/min
* Severe hepatic failure
* Other contraindications to ropivacaïne (allergy, medical history of porphyria, hypovolemia)
* Contraindications to acetaminophen
* Contraindications to morphine

Primary outcomes:
measure: Morphine consumption during the first postoperative 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit
timeFrame: 24 hours
measure: Morphine consumption during the first postoperative 48 hours
timeFrame: 48 hours
measure: Pain intensity at rest assessed by the visual analog scale for pain
timeFrame: 48 hours
measure: Pain intensity at mobilisation assessed by the visual analog scale for pain
timeFrame: 48 hours
measure: Percentage of patients suffering from insomnia during the first and/or the second postoperative night
timeFrame: 48 hours
measure: Percentage of patients suffering from awakenings during the first and/or the second postoperative night
timeFrame: 48 hours
measure: Incidence of morphine side effects
timeFrame: 48 hours
measure: Incidence of TAP block side effects
timeFrame: 48 hours
measure: Ropivacaine sides effects
timeFrame: 48 hours
measure: Post-operative morbidity
timeFrame: Day 30
measure: 30-day survival
timeFrame: Day 30
measure: Duration of hospital stay
timeFrame: Expected average of 10 days
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
state: Doubs
Study officials:
affiliation: Centre Hospitalier Régional Universitaire de Besancon
name: Julien Chenet, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.