Aortic Aneurysm, AbdominalPhase 3ETAPNCT02292667
Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery
A Phase 3 study testing TAP block, PCA with Chlorhydrate of Morphine and Acetaminophen in people with Aortic Aneurysm, Abdominal and Pain, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Pain, Anesthesia, Local
- What is being tested?
- TAP block, PCA with Chlorhydrate of Morphine and Acetaminophen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon, Doubs, 25000
Julien Chenet, MD, +33381669121, julchenet@gmail.com
Guillaume Besch, MD, +33381668166, guillaume.besch@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- TAP block, PCA with Chlorhydrate of Morphine, Acetaminophen
- Keywords
- Transversus Abdominis Plane Block, Postoperative Pain Management, Open Repair of Aortic Abdominal Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
Also called Transversus Abdominis Plane 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.
PCA with Chlorhydrate of MorphineDrug
Also called Patient Controlled Analgesia (PCA)
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.
AcetaminophenDrug
Also called Paracetamol
1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| TAP BLOCK | Experimental | 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. Receives: Procedure: TAP block; Drug: PCA with Chlorhydrate of Morphine; Drug: Acetaminophen |
| CONTROL | Active comparator | 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. Receives: Drug: PCA with Chlorhydrate of Morphine; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (12)
Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit
Measured: 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.
Measured: 48 hours
Pain intensity at rest assessed by the visual analog scale for pain
Measured: 48 hours
Pain intensity at mobilisation assessed by the visual analog scale for pain
Measured: 48 hours
Percentage of patients suffering from insomnia during the first and/or the second postoperative night
Measured: 48 hours
Percentage of patients suffering from awakenings during the first and/or the second postoperative night
Measured: 48 hours
Incidence of morphine side effects
Morphine side effects include: nausea, vomiting, pruritus, drowsiness, respiratory depression
Measured: 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.
Measured: 48 hours
Ropivacaine sides effects
Ropivacaine sides effects are: cardiac toxicity, neurologic toxicity, allergy
Measured: 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.
Measured: Day 30
30-day survival
Measured: Day 30
Duration of hospital stay
Patients will be followed for the duration of hospital stay, an expected average of 10 days.
Measured: Expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien CHENET, Centre Hospitalier Universitaire de Besancon
- Investigators
- Julien Chenet, MD, Principal investigator, Centre Hospitalier Régional Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292667
- Sponsor's protocol ID
- API/2014/52
- Other IDs
- 2014-003665-20, 2014
- Acronym
- ETAP
- Status last verified
- Aug 2016
- First submitted
- 5 Nov 2014
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 18165577
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery
- ClinicalTrials.gov ID
- NCT02292667
- Acronym / sponsor ID
- ETAP / API/2014/52
- Conditions
- Aortic Aneurysm, Abdominal, Pain, Anesthesia, Local
- Keywords
- Transversus Abdominis Plane Block, Postoperative Pain Management, Open Repair of Aortic Abdominal Aneurysm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP BLOCK | Experimental | Procedure: TAP block, Drug: PCA with Chlorhydrate of Morphine, Drug: AcetaminophenPatients 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. |
| CONTROL | Active comparator | Drug: PCA with Chlorhydrate of Morphine, Drug: AcetaminophenPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP blockAlso: Transversus Abdominis Plane BlockThe 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. | Procedure or surgery | TAP BLOCK |
| PCA with Chlorhydrate of MorphineAlso: Patient Controlled Analgesia (PCA)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. | Drug | CONTROL, TAP BLOCK |
| AcetaminophenAlso: Paracetamol1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure. | Drug | CONTROL, TAP BLOCK |
Primary outcome
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.
12 secondary outcomes
Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit
Time frame: 24 hours
Morphine consumption during the first postoperative 48 hours
Time frame: 48 hours
Pain intensity at rest assessed by the visual analog scale for pain
Time frame: 48 hours
Pain intensity at mobilisation assessed by the visual analog scale for pain
Time frame: 48 hours
Percentage of patients suffering from insomnia during the first and/or the second postoperative night
Time frame: 48 hours
Percentage of patients suffering from awakenings during the first and/or the second postoperative night
Time frame: 48 hours
Incidence of morphine side effects
Time frame: 48 hours
Incidence of TAP block side effects
Time frame: 48 hours
Ropivacaine sides effects
Time frame: 48 hours
Post-operative morbidity
Time frame: Day 30
30-day survival
Time frame: Day 30
Duration of hospital stay
Time frame: Expected average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Results publication: PubMed 18165577McDonnell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Chenet, MD principal investigator
Centre Hospitalier Régional Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAP block, PCA with Chlorhydrate of Morphine and Acetaminophen in people with Aortic Aneurysm, Abdominal and Pain, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Chenet, MD (+33(0)622640818, julchenet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption during the first postoperative 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.