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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Anesthesia, Local; Aortic Aneurysm, Abdominal
• Intervention / Treatment: Procedure: TAP block; Drug: PCA with Chlorhydrate of Morphine; Drug: Acetaminophen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Julien Chenet, MD; Phone Number: +33(0)622640818; Email: julchenet@gmail.com
• Study Contact Backup: Name: Guillaume Besch, MD; Phone Number: +33(0)677897039; Email: guillaume.besch@gmail.com

Study Locations

• France
  • Doubs
    • Besançon, Doubs, France, 25000
      • Recruiting
      • CHU Besançon
      • Contact: Julien Chenet, MD; Phone Number: +33381669121; Email: julchenet@gmail.com
      • Contact: Guillaume Besch, MD; Phone Number: +33381668166; Email: guillaume.besch@gmail.com
      • Principal Investigator: Julien Chenet, MD
      • Sub-Investigator: Emmanuel SAMAIN, MD
      • Sub-Investigator: Sébastien Pili-Floury, MD
      • Sub-Investigator: Simon Rinckenbach, MD
      • Sub-Investigator: Guillaume BESCH, MD
      • Sub-Investigator: Thomas Levy, MD
      • Sub-Investigator: Eviane Farah, MD
      • Sub-Investigator: Angeline Chopard-Guillemin, MD
      • Sub-Investigator: Marie-Hélène Tripard, MD
      • Sub-Investigator: Patrick Lemounaud, MD
      • Sub-Investigator: Mazen Al Sayed Obeid, MD
      • Sub-Investigator: Emilie Ducroux, MD
      • Sub-Investigator: Stéphanie Villeminey, MD
      • Sub-Investigator: Vincenzo Ritucci, MD
      • Sub-Investigator: Vivien Salignon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Transversus Abdominis Plane Block; 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.; Other Names: Patient Controlled Analgesia (PCA); Drug: Acetaminophen; 1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure.; Other Names: Paracetamol
Active Comparator: 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.	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.; Other Names: Patient Controlled Analgesia (PCA); Drug: Acetaminophen; 1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure.; Other Names: Paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit		24 hours
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
Pain intensity at rest assessed by the visual analog scale for pain		48 hours
Pain intensity at mobilisation assessed by the visual analog scale for pain		48 hours
Percentage of patients suffering from insomnia during the first and/or the second postoperative night		48 hours
Percentage of patients suffering from awakenings during the first and/or the second postoperative night		48 hours
Incidence of morphine side effects	Morphine side effects include: nausea, vomiting, pruritus, drowsiness, respiratory depression	48 hours
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
Ropivacaine sides effects	Ropivacaine sides effects are: cardiac toxicity, neurologic toxicity, allergy	48 hours
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
30-day survival		Day 30
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Julien Chenet, MD, Centre Hospitalier Régional Universitaire de Besançon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Estimate): August 12, 2016
• Last Update Submitted That Met QC Criteria: August 11, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Transversus Abdominis Plane Block; Postoperative Pain Management; Open Repair of Aortic Abdominal Aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine
• Other Study ID Numbers: API/2014/52; 2014-003665-20 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No