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

Pain Clinical Trial

— ETAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02292667
• Other study ID #: API/2014/52
• Secondary ID: 2014-003665-20
• Status: Recruiting
• Phase: Phase 3
• First received: November 5, 2014
• Last updated: August 11, 2016
• Start date: January 2015
• Est. completion date: January 2019

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Julien Chenet, MD
• Phone: +33(0)622640818
• Email: julchenet[@]gmail.com
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Local
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Pain

Intervention

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.
• Acetaminophen
1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure.

Locations

Country	Name	City	State
France	CHU Besançon	Besançon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption during the first postoperative 24 hours	The morphine consumption during the first postoperative 24 hours is the total dose of morphine delivered both by the patient-controlled analgesia device and during the titration of morphine by the nurse in the post-anesthesia care unit.	24 hours	No
Secondary	Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit		24 hours	No
Secondary	Morphine consumption during the first postoperative 48 hours	The morphine consumption during the first postoperative 48 hours is the total dose of morphine delivered both by the patient-controlled analgesia device and during the titration of morphine by the nurse in the post-anesthesia care unit.	48 hours	No
Secondary	Pain intensity at rest assessed by the visual analog scale for pain		48 hours	No
Secondary	Pain intensity at mobilisation assessed by the visual analog scale for pain		48 hours	No
Secondary	Percentage of patients suffering from insomnia during the first and/or the second postoperative night		48 hours	No
Secondary	Percentage of patients suffering from awakenings during the first and/or the second postoperative night		48 hours	No
Secondary	Incidence of morphine side effects	Morphine side effects include: nausea, vomiting, pruritus, drowsiness, respiratory depression	48 hours	Yes
Secondary	Incidence of TAP block side effects	TAP block side effects are any side effect occuring in the ETAP group and considered to be related to the TAP block by the safety board of the study.	48 hours	Yes
Secondary	Ropivacaine sides effects	Ropivacaine sides effects are: cardiac toxicity, neurologic toxicity, allergy	48 hours	Yes
Secondary	Post-operative morbidity	Any of the following events occuring within the 30 first post-operative days: myocardial infarction, acute congestive heart failure, ventricular tachycardia, ventricular fibrillation, atelectasis, pneumonia, acute respiratory failure requiring invasive or non invasive mechanical ventilation, acute kidney failure, non infectious systemic inflammatory response syndrome, sepsis, surgical wound complication.	Day 30	No
Secondary	30-day survival		Day 30	No
Secondary	Duration of hospital stay	Patients will be followed for the duration of hospital stay, an expected average of 10 days.	Expected average of 10 days	No