Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair

Study Overview
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Brief Summary
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The aim of the study is to determine wether continuous wound infusion with local anaesthetic plus a single dose intravenous morphine is non-inferior to postoperative analgesia provided with continuous thoracic epidural infusion of local anaesthetic plus opiate, in patients undergoing open abdominal aortic aneurism repair.

Official Title
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Analgesia Postoperatoria Mediante Catetere Perdurare e Analgesia Postoperatoria Mediante Infusione Continua Periferia Nell'Intervento Chirurgico Per Riparazione Chirurgica di Aneurismi Dell'Aorta Addominale: Tecniche a Confronto

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Levobupivacaine wound infiltration
* Drug: Levobupivacaine epidural bolus
* Drug: Sufentanil epidural bolus
* Drug: Morphine
* Device: Epidural catheter placement
* Device: Wound infusion catheters placement
* Drug: Levobupivacaine plus sufentanil epidural infusion
* Drug: Levobupivacaine wound infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for elective open aortic aneurism repair Exclusion Criteria: Patient refusal Platelet count < 80*10^3/mcL International Normalised Ratio > 1.5 Other contraindications to the placement of epidural catheter, including ongoing anti platelet or anticoagulant treatment not suspended according to national guidelines

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural infusion<br>Thoracic epidural bolus of 10 ml levobupivacaine 0.25% plus sufentanil 0.15 mcg/kg before end of surgery, followed by continuous epidural infusion of 0.12% levobupivacaine plus 0.4 mcg/ml at 5 ml/h infusion rate for 48 hours. | Drug: Paracetamol<br>* 1 g every 8 hours<br>Drug: Levobupivacaine epidural bolus<br>* Epidural bolus of 10 ml 0.25% levobupivacaine<br>Drug: Sufentanil epidural bolus<br>* Epidural bolus of 0.15 mcg/kg sufentanil<br>Device: Epidural catheter placement<br>* Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space<br>Drug: Levobupivacaine plus sufentanil epidural infusion<br>* Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h<br>|
| Experimental: Wound infusion plus morphine bolus<br>Intravenous slow bolus of 10 mg morphine, wound infiltration with 10 ml levobupivacaine 0.5%, followed by pre-peritoneal continuous wound infusion of levobupivacaine 0.25% at 4 ml/h infusion rate for 48 hours. | Drug: Paracetamol<br>* 1 g every 8 hours<br>Drug: Levobupivacaine wound infiltration<br>* Wound infiltration with 10 ml levobupivacaine 0.5%<br>Drug: Morphine<br>* Intravenous slow bolus of 10 mg morphine<br>Device: Wound infusion catheters placement<br>* Pre-peritoneal placement of two catheters for wound infusion<br>Drug: Levobupivacaine wound infusion<br>* Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours |  | Average of the NRS recorded at the different time-points (up to 48 hours after emergence from general anaesthesia) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for rescue doses of morphine at each time-point | Need for a bolus of 5 mg intravenous morphine to relief pain | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | 
| Number of patients requiring oxygen administration at each time-point |  | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | 
| Number of patients that have restored bowel function at each time-point | Time to first stool analysis | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | 
| Number of patients whose urinary catheter was removed at each time-point | Time to catheter removal analysis | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | 
| Number of patients that have restored ability to walk at each time-point |  | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | 
| Non-invasive blood pressure (mmHg) at each time-point | Blood pressure (systolic, diastolic, mean in mmHg) | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | 
| Length of hospital stay |  | Follow-up of up to 3 months after surgery | 
| Heart rate (bpm) at each time-point |  | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia | 
| Incidence of postoperative nausea and vomiting |  | 0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia |