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

Primary Purpose

Aortic Aneurysm, Abdominal, Pain, Anesthesia, Local

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
TAP block
PCA with Chlorhydrate of Morphine
Acetaminophen
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring Transversus Abdominis Plane Block, Postoperative Pain Management, Open Repair of Aortic Abdominal Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU BesançonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP BLOCK

CONTROL

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit
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.
Pain intensity at rest assessed by the visual analog scale for pain
Pain intensity at mobilisation assessed by the visual analog scale for pain
Percentage of patients suffering from insomnia during the first and/or the second postoperative night
Percentage of patients suffering from awakenings during the first and/or the second postoperative night
Incidence of morphine side effects
Morphine side effects include: nausea, vomiting, pruritus, drowsiness, respiratory depression
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.
Ropivacaine sides effects
Ropivacaine sides effects are: cardiac toxicity, neurologic toxicity, allergy
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.
30-day survival
Duration of hospital stay
Patients will be followed for the duration of hospital stay, an expected average of 10 days.

Full Information

First Posted
November 5, 2014
Last Updated
August 11, 2016
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02292667
Brief Title
Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery
Acronym
ETAP
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal, Pain, Anesthesia, Local
Keywords
Transversus Abdominis Plane Block, Postoperative Pain Management, Open Repair of Aortic Abdominal Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAP BLOCK
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TAP block
Other Intervention Name(s)
Transversus Abdominis Plane Block
Intervention Description
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
Drug
Intervention Name(s)
PCA with Chlorhydrate of Morphine
Other Intervention Name(s)
Patient Controlled Analgesia (PCA)
Intervention Description
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
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Paracetamol
Intervention Description
1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure.
Primary Outcome Measure Information:
Title
Morphine consumption during the first postoperative 24 hours
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit
Time Frame
24 hours
Title
Morphine consumption during the first postoperative 48 hours
Description
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.
Time Frame
48 hours
Title
Pain intensity at rest assessed by the visual analog scale for pain
Time Frame
48 hours
Title
Pain intensity at mobilisation assessed by the visual analog scale for pain
Time Frame
48 hours
Title
Percentage of patients suffering from insomnia during the first and/or the second postoperative night
Time Frame
48 hours
Title
Percentage of patients suffering from awakenings during the first and/or the second postoperative night
Time Frame
48 hours
Title
Incidence of morphine side effects
Description
Morphine side effects include: nausea, vomiting, pruritus, drowsiness, respiratory depression
Time Frame
48 hours
Title
Incidence of TAP block side effects
Description
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.
Time Frame
48 hours
Title
Ropivacaine sides effects
Description
Ropivacaine sides effects are: cardiac toxicity, neurologic toxicity, allergy
Time Frame
48 hours
Title
Post-operative morbidity
Description
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.
Time Frame
Day 30
Title
30-day survival
Time Frame
Day 30
Title
Duration of hospital stay
Description
Patients will be followed for the duration of hospital stay, an expected average of 10 days.
Time Frame
Expected average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Chenet, MD
Phone
+33(0)622640818
Email
julchenet@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Besch, MD
Phone
+33(0)677897039
Email
guillaume.besch@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Chenet, MD
Organizational Affiliation
Centre Hospitalier Régional Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Chenet, MD
Phone
+33381669121
Email
julchenet@gmail.com
First Name & Middle Initial & Last Name & Degree
Guillaume Besch, MD
Phone
+33381668166
Email
guillaume.besch@gmail.com
First Name & Middle Initial & Last Name & Degree
Julien Chenet, MD
First Name & Middle Initial & Last Name & Degree
Emmanuel Samain, MD
First Name & Middle Initial & Last Name & Degree
Sébastien Pili-Floury, MD
First Name & Middle Initial & Last Name & Degree
Simon Rinckenbach, MD
First Name & Middle Initial & Last Name & Degree
Guillaume Besch, MD
First Name & Middle Initial & Last Name & Degree
Thomas Levy, MD
First Name & Middle Initial & Last Name & Degree
Eviane Farah, MD
First Name & Middle Initial & Last Name & Degree
Angeline Chopard-Guillemin, MD
First Name & Middle Initial & Last Name & Degree
Marie-Hélène Tripard, MD
First Name & Middle Initial & Last Name & Degree
Patrick Lemounaud, MD
First Name & Middle Initial & Last Name & Degree
Mazen Al Sayed Obeid, MD
First Name & Middle Initial & Last Name & Degree
Emilie Ducroux, MD
First Name & Middle Initial & Last Name & Degree
Stéphanie Villeminey, MD
First Name & Middle Initial & Last Name & Degree
Vincenzo Ritucci, MD
First Name & Middle Initial & Last Name & Degree
Vivien Salignon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18165577
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.
Results Reference
result

Learn more about this trial

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

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