Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery
Overview
- Phase
- Phase 3
- Intervention
- TAP block
- Conditions
- Aortic Aneurysm, Abdominal
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Morphine consumption during the first postoperative 24 hours
- Last Updated
- 9 years ago
Overview
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.
Investigators
Julien CHENET
M.D.
Centre Hospitalier Universitaire de Besancon
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
Arms & Interventions
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.
Intervention: TAP block
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.
Intervention: PCA with Chlorhydrate of Morphine
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.
Intervention: Acetaminophen
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.
Intervention: PCA with Chlorhydrate of Morphine
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.
Intervention: Acetaminophen
Outcomes
Primary Outcomes
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 Outcomes
- Percentage of patients suffering from awakenings during the first and/or the second postoperative night(48 hours)
- Incidence of morphine side effects(48 hours)
- Incidence of TAP block side effects(48 hours)
- Ropivacaine sides effects(48 hours)
- Post-operative morbidity(Day 30)
- 30-day survival(Day 30)
- Duration of hospital stay(Expected average of 10 days)
- 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(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)