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

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ClinicalTrials.gov Identifier: NCT02292667
Recruitment Status : Unknown
Verified August 2016 by Julien CHENET, Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : November 17, 2014
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Julien CHENET, Centre Hospitalier Universitaire de Besancon

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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Pain Anesthesia, Local Procedure: TAP block Drug: PCA with Chlorhydrate of Morphine Drug: Acetaminophen Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Paracetamol




Primary Outcome Measures :
  1. Morphine consumption during the first postoperative 24 hours [ Time Frame: 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.


Secondary Outcome Measures :
  1. Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit [ Time Frame: 24 hours ]
  2. Morphine consumption during the first postoperative 48 hours [ Time Frame: 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.

  3. Pain intensity at rest assessed by the visual analog scale for pain [ Time Frame: 48 hours ]
  4. Pain intensity at mobilisation assessed by the visual analog scale for pain [ Time Frame: 48 hours ]
  5. Percentage of patients suffering from insomnia during the first and/or the second postoperative night [ Time Frame: 48 hours ]
  6. Percentage of patients suffering from awakenings during the first and/or the second postoperative night [ Time Frame: 48 hours ]
  7. Incidence of morphine side effects [ Time Frame: 48 hours ]
    Morphine side effects include: nausea, vomiting, pruritus, drowsiness, respiratory depression

  8. Incidence of TAP block side effects [ Time Frame: 48 hours ]
    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.

  9. Ropivacaine sides effects [ Time Frame: 48 hours ]
    Ropivacaine sides effects are: cardiac toxicity, neurologic toxicity, allergy

  10. Post-operative morbidity [ Time Frame: Day 30 ]
    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.

  11. 30-day survival [ Time Frame: Day 30 ]
  12. Duration of hospital stay [ Time Frame: Expected average of 10 days ]
    Patients will be followed for the duration of hospital stay, an expected average of 10 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292667


Contacts
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Contact: Julien Chenet, MD +33(0)622640818 julchenet@gmail.com
Contact: Guillaume Besch, MD +33(0)677897039 guillaume.besch@gmail.com

Locations
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France
CHU Besançon Recruiting
Besançon, Doubs, France, 25000
Contact: Julien Chenet, MD    +33381669121    julchenet@gmail.com   
Contact: Guillaume Besch, MD    +33381668166    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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Julien Chenet, MD Centre Hospitalier Régional Universitaire de Besancon

Publications of Results:
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Responsible Party: Julien CHENET, M.D., Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02292667     History of Changes
Other Study ID Numbers: API/2014/52
2014-003665-20 ( EudraCT Number )
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Julien CHENET, Centre Hospitalier Universitaire de Besancon:
Transversus Abdominis Plane Block
Postoperative Pain Management
Open Repair of Aortic Abdominal Aneurysm

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Morphine
Acetaminophen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics