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

NCT ID: NCT02292667

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-01-31

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.

Conditions

Aortic Aneurysm, Abdominal; Pain; Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAP BLOCK

Patients included in the ETAP group will receive the combination of a bilateral ultrasound-guided Transversus Abdominis Plane (TAP) block and a multimodal intravenous analgesia protocol for the postoperative pain management after the surgical open repair of an aortic abdominal aneurysm.

The TAP block consists in 2 ultrasound-guided injections of Ropivacaine 0.375% on each side of the abdominal wall between the internal oblique and transversus abdominis muscles: 1 subcostal injection and 1 supra-iliac injection (i.e 10 ml of Ropivacaine 0.375% by injection).

The multimodal intravenous analgesia protocol consists in the association of intravenous infusion of 1 g of Acetaminophen every 6 h and intravenous patient-controlled analgesia (PCA) with Chlorhydrate of Morphine 1 mg/ml.

Group Type: EXPERIMENTAL

TAP block

Intervention Type: PROCEDURE

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.

PCA with Chlorhydrate of Morphine

Intervention Type: DRUG

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

Intervention Type: DRUG

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

CONTROL

Patients included in the CONTROL group will receive a multimodal intravenous analgesia protocol alone for the postoperative pain management after the surgical open repair of an aortic abdominal aneurysm.

The multimodal intravenous analgesia protocol consists in the association of intravenous infusion of 1 g of Acetaminophen every 6 h and intravenous patient-controlled analgesia (PCA) with Chlorhydrate of Morphine 1 mg/ml.

Group Type: ACTIVE_COMPARATOR

PCA with Chlorhydrate of Morphine

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Acetaminophen

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

Intervention Type: DRUG

Other Intervention Names

Transversus Abdominis Plane Block; Patient Controlled Analgesia (PCA); Paracetamol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Julien CHENET

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julien Chenet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional Universitaire de Besancon

Locations

CHU Besançon

Besançon, Doubs, France

Site Status: RECRUITING

Countries

France

Central Contacts

Julien Chenet, MD

Role: CONTACT

julchenet@gmail.com

+33(0)622640818

Guillaume Besch, MD

Role: CONTACT

guillaume.besch@gmail.com

+33(0)677897039

Facility Contacts

Julien Chenet, MD

Role: primary

julchenet@gmail.com

+33381669121

Guillaume Besch, MD

Role: backup

guillaume.besch@gmail.com

+33381668166

References

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.

Reference Type: RESULT

PMID: 18165577 (View on PubMed)

Other Identifiers

2014-003665-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

API/2014/52

Identifier Type: -

Identifier Source: org_study_id